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    Clinical Trial Results:
    TACTI-002 (Two ACTive Immunotherapeutics): A multicenter, open label, Phase II study in patients with previously untreated unresectable or metastatic non-small cell lung cancer (NSCLC), or recurrent PD-X refractory NSCLC or with recurrent or metastatic squamous head and neck cancer (HNSCC) receiving the soluble LAG-3 fusion protein eftilagimod alpha (IMP321) in combination with pembrolizumab (PD-1 antagonist)

    Summary
    EudraCT number
    		 2018-001994-25
    Trial protocol
    		 GB   ES   PL  
    Global end of trial date
    25 Nov 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Dec 2025
    First version publication date
    11 Dec 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TACTI-002(P015);Keynote-PN798
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03625323
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Immutep S.A.S.
    Sponsor organisation address
    Parc Les Algorithmes Bâtiment 7- Le Pythagore Route de l’Orme – RD128 , SAINT-AUBIN, France, 91190
    Public contact
    Clinical Trial Disclosure Enquiries, Immutep S.A.S., +33 160 123 250, enquiries@immutep.com
    Scientific contact
    Clinical Trial Disclosure Enquiries, Immutep S.A.S., +33 160 123 250, enquiries@immutep.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Nov 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Jun 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Nov 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the response rate of eftilagimod alpha in combination with pembrolizumab in patients with advanced, metastatic, recurrent NSCLC and HNSCC
    Protection of trial subjects
    The study was conducted in accordance with the most recent version of the Declaration of Helsinki and the International Council for Harmonization (ICH) E6 Good Clinical Practices (GCP) guidelines. At regular intervals, the Data Monitoring Committee (DMC) monitored the available safety and efficacy data and demographics of all subjects (Parts A-C). Additionally, the DMC reviewed the efficacy and safety data after the minimum number of responses was reached for each part of the study. Subjects included in this decision required at least one tumor imaging after initiating treatment. The DMC then made a recommendation for each part of the study, whether stage 2 or an extension could be independently opened
    Background therapy
    		 No background therapy was given during the study
    Evidence for comparator
    		 No comparator was used during the study
    Actual start date of recruitment
    21 Feb 2019
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 2
    Country: Number of subjects enrolled
    Spain: 107
    Country: Number of subjects enrolled
    United Kingdom: 32
    Country: Number of subjects enrolled
    United States: 18
    Country: Number of subjects enrolled
    Ukraine: 12
    Country: Number of subjects enrolled
    Australia: 16
    Worldwide total number of subjects
    187
    EEA total number of subjects
    109
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    74
    From 65 to 84 years
    112
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 The first ICF for the study was signed on February 21, 2019. Recruitment ended on November 30, 2021. 18 sites in 6 countries. Number of sites per country: Australia (2), Poland (1), Spain (8), UK (3), Ukraine (2) and US (2).

    Pre-assignment
    Screening details
    		 Participants could enrol in the study if: NSCLC previously untreated for stage IIIB or stage IV disease (Part A); NSCLC after confirmed progression on first-line treatment and proven resistance to PD (L)1 inhibitors (Part B) or HNSCC of the oral cavity, oropharynx, hypopharynx, or larynx after failure of prior platinum-based therapy (Part C)

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part A: 1st Line NSCLC
    Arm description
    		 1st line, PD (L)1 naïve participants in metastatic setting NSCLC: histologically- or cytologically-confirmed diagnosis of NSCLC stage IIIB not amenable to curative treatment or stage IV not amenable to EGFR/ALK based therapy, treatment-naïve for systemic therapy given for advanced/metastatic disease (previous palliative radiotherapy for advanced/metastatic disease acceptable).
    Arm type
    		 Experimental

    Investigational medicinal product name
    eftilagimod alpha
    Investigational medicinal product code
    IMP321
    Other name
    eftilagimod alfa, efti
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Eftilagimod alpha (efti; IMP321) was injected every 2 weeks until end of Cycle 8 (12 doses). Thereafter efti was administered every 3 weeks starting Cycle 9 until end of Cycle 18 (10 doses). Efti was administered as a s.c. injection (single anatomical site) on the anterior face of the thigh

    Investigational medicinal product name
    pembrolizumab KEYTRUDA®
    Investigational medicinal product code
    MK-3475
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Pembrolizumab was administered at a dose of 200 mg using a 30-minute i.v. infusion on Day 1 of each 3-week treatment Cycle after all procedures and assessments had been completed. Pembrolizumab was given on Day 1 from Cycle 1 to Cycle 35.

    Arm title
    		 Part B: 2nd line NSCLC
    Arm description
    		 2nd line, PD (L)1 refractory NSCLC: Histologically- or cytologically-confirmed diagnosis of NSCLC after failure of first-line treatment (for metastatic disease) with at least two cycles of any PD 1/PD L1 containing based therapy (e.g., nivolumab, pembrolizumab, avelumab, durvalumab, etc.) alone, or in combination with any other immunotherapeutic or chemotherapy given as part of first-line treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    eftilagimod alpha
    Investigational medicinal product code
    IMP321
    Other name
    eftilagimod alfa, efti
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Eftilagimod alpha (efti; IMP321) was injected every 2 weeks until end of Cycle 8 (12 doses). Thereafter efti was administered every 3 weeks starting Cycle 9 until end of Cycle 18 (10 doses). Efti was administered as a s.c. injection (single anatomical site) on the anterior face of the thigh

    Investigational medicinal product name
    pembrolizumab KEYTRUDA®
    Investigational medicinal product code
    MK-3475
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Pembrolizumab was administered at a dose of 200 mg using a 30-minute i.v. infusion on Day 1 of each 3-week treatment Cycle after all procedures and assessments had been completed. Pembrolizumab was given on Day 1 from Cycle 1 to Cycle 35.

    Arm title
    		 Part C: 2nd line HNSCC
    Arm description
    		 2nd line PD (L)1-naïve HNSCC: Histologically- or cytologically-confirmed recurrent disease not amenable to curative treatment with local or systemic therapy, or metastatic (disseminated) head and HNSCC of the oral cavity, oropharynx, hypopharynx, or larynx that was considered incurable by local therapies after failure of prior platinum-based therapy.
    Arm type
    		 Experimental

    Investigational medicinal product name
    eftilagimod alpha
    Investigational medicinal product code
    IMP321
    Other name
    eftilagimod alfa, efti
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Eftilagimod alpha (efti; IMP321) was injected every 2 weeks until end of Cycle 8 (12 doses). Thereafter efti was administered every 3 weeks starting Cycle 9 until end of Cycle 18 (10 doses). Efti was administered as a s.c. injection (single anatomical site) on the anterior face of the thigh

    Investigational medicinal product name
    pembrolizumab KEYTRUDA®
    Investigational medicinal product code
    MK-3475
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Pembrolizumab was administered at a dose of 200 mg using a 30-minute i.v. infusion on Day 1 of each 3-week treatment Cycle after all procedures and assessments had been completed. Pembrolizumab was given on Day 1 from Cycle 1 to Cycle 35.

    Number of subjects in period 1
    		Part A: 1st Line NSCLC Part B: 2nd line NSCLC Part C: 2nd line HNSCC
    Started
    114
    36
    37
    Completed
    22
    2
    4
    Not completed
    92
    34
    33
         Physician decision
    3
    -
    2
         Consent withdrawn by subject
    2
    -
    1
         Disease progression
    47
    31
    19
         Death
    11
    1
    6
         Other
    14
    2
    -
         Adverse event
    14
    -
    5
         Prohibited medication
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part A: 1st Line NSCLC
    Reporting group description
    		 1st line, PD (L)1 naïve participants in metastatic setting NSCLC: histologically- or cytologically-confirmed diagnosis of NSCLC stage IIIB not amenable to curative treatment or stage IV not amenable to EGFR/ALK based therapy, treatment-naïve for systemic therapy given for advanced/metastatic disease (previous palliative radiotherapy for advanced/metastatic disease acceptable).

    Reporting group title
    Part B: 2nd line NSCLC
    Reporting group description
    		 2nd line, PD (L)1 refractory NSCLC: Histologically- or cytologically-confirmed diagnosis of NSCLC after failure of first-line treatment (for metastatic disease) with at least two cycles of any PD 1/PD L1 containing based therapy (e.g., nivolumab, pembrolizumab, avelumab, durvalumab, etc.) alone, or in combination with any other immunotherapeutic or chemotherapy given as part of first-line treatment.

    Reporting group title
    Part C: 2nd line HNSCC
    Reporting group description
    		 2nd line PD (L)1-naïve HNSCC: Histologically- or cytologically-confirmed recurrent disease not amenable to curative treatment with local or systemic therapy, or metastatic (disseminated) head and HNSCC of the oral cavity, oropharynx, hypopharynx, or larynx that was considered incurable by local therapies after failure of prior platinum-based therapy.

    Reporting group values
    		 Part A: 1st Line NSCLC Part B: 2nd line NSCLC Part C: 2nd line HNSCC Total
    Number of subjects
    		 114 36 37 187
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 39 15 20 74
        From 65 years
    		 75 21 17 113
    Age continuous
    Units: years
        median (full range (min-max))
    		 67.0 (44 to 85) 67.0 (46 to 84) 63.0 (48 to 84) -
    Gender categorical
    Units: Subjects
        Female
    		 30 14 4 48
        Male
    		 84 22 33 139
    Race
    Units: Subjects
        White
    		 109 34 35 178
        Black or African American
    		 2 2 0 4
        Asian
    		 1 0 1 2
        Unknown
    		 2 0 1 3
    Smoking history
    Units: Subjects
        Non-smoker
    		 6 5 5 16
        Ex- or current smoker
    		 108 31 32 171

    End points

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    End points reporting groups
    Reporting group title
    Part A: 1st Line NSCLC
    Reporting group description
    		 1st line, PD (L)1 naïve participants in metastatic setting NSCLC: histologically- or cytologically-confirmed diagnosis of NSCLC stage IIIB not amenable to curative treatment or stage IV not amenable to EGFR/ALK based therapy, treatment-naïve for systemic therapy given for advanced/metastatic disease (previous palliative radiotherapy for advanced/metastatic disease acceptable).

    Reporting group title
    Part B: 2nd line NSCLC
    Reporting group description
    		 2nd line, PD (L)1 refractory NSCLC: Histologically- or cytologically-confirmed diagnosis of NSCLC after failure of first-line treatment (for metastatic disease) with at least two cycles of any PD 1/PD L1 containing based therapy (e.g., nivolumab, pembrolizumab, avelumab, durvalumab, etc.) alone, or in combination with any other immunotherapeutic or chemotherapy given as part of first-line treatment.

    Reporting group title
    Part C: 2nd line HNSCC
    Reporting group description
    		 2nd line PD (L)1-naïve HNSCC: Histologically- or cytologically-confirmed recurrent disease not amenable to curative treatment with local or systemic therapy, or metastatic (disseminated) head and HNSCC of the oral cavity, oropharynx, hypopharynx, or larynx that was considered incurable by local therapies after failure of prior platinum-based therapy.

    Primary: Overall Response Rate Unconfirmed

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    End point title
    		 Overall Response Rate Unconfirmed [1]
    End point description
    ORR was defined as the number of participants for each dose level whose best overall response is rated as iCR or iPR per immune Response Evaluation Criteria In Solid Tumors (iRECIST) for target lesions and assessed by CT or MRI per local assessment. iCR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. 95% Confidence interval calculated using Clopper-Pearson method.
    End point type
    Primary
    End point timeframe
    Radiological assessments according to iRECIST. from screening onwards every 9 weeks until week 36, then every 12 weeks thereafter.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this endpoint
    End point values
    		 Part A: 1st Line NSCLC Part B: 2nd line NSCLC Part C: 2nd line HNSCC
    Number of subjects analysed
    114
    36
    37
    Units: Number of patients
    46
    3
    11
    No statistical analyses for this end point

    Primary: Overall Response Rate Confirmed

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    End point title
    		 Overall Response Rate Confirmed [2]
    End point description
    ORR was defined as the number of participants for each dose level whose best overall response is rated as iCR or iPR per immune Response Evaluation Criteria In Solid Tumors (iRECIST) for target lesions and assessed by CT or MRI per local assessment. iCR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. 95% Confidence interval calculated using Clopper-Pearson method.
    End point type
    Primary
    End point timeframe
    Radiological assessments according to iRECIST. from screening onwards every 9 weeks until week 36, then every 12 weeks thereafter.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this endpoint
    End point values
    		 Part A: 1st Line NSCLC Part B: 2nd line NSCLC Part C: 2nd line HNSCC
    Number of subjects analysed
    114
    36
    37
    Units: Number of paticipants
    40
    3
    10
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 27 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Part A: 1st Line NSCLC
    Reporting group description
    		 Reported data is based on adverse events with onset dates on or after the first dose of study drug regardless of causality

    Reporting group title
    Part B: 2nd line NSCLC
    Reporting group description
    		 Reported data is based on adverse events with onset dates on or after the first dose of study drug regardless of causality

    Reporting group title
    Part C: 2nd line HNSCC
    Reporting group description
    		 Reported data is based on adverse events with onset dates on or after the first dose of study drug regardless of causality

    Serious adverse events
    		 Part A: 1st Line NSCLC Part B: 2nd line NSCLC Part C: 2nd line HNSCC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    54 / 114 (47.37%)
    9 / 36 (25.00%)
    20 / 37 (54.05%)
         number of deaths (all causes)
    84
    30
    31
         number of deaths resulting from adverse events
    14
    2
    7
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour pain
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 36 (2.78%)
    2 / 37 (5.41%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphoma
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Prostate cancer
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tumour haemorrhage
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Arterial thrombosis
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    3 / 114 (2.63%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 3
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gait disturbance
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Asthma
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    8 / 114 (7.02%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Pneumonitis
         subjects affected / exposed
    4 / 114 (3.51%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    4 / 5
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    4 / 114 (3.51%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 36 (2.78%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 36 (0.00%)
    2 / 37 (5.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    Acute respiratory failure
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 36 (2.78%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Bronchial fistula
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Immune-mediated pneumonitis
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 36 (2.78%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biopsy lymph gland
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal stoma complication
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Toxicity to various agents
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    3 / 114 (2.63%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    2 / 114 (1.75%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial thrombosis
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Nervous system disorders
    Seizure
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 36 (0.00%)
    2 / 37 (5.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 114 (2.63%)
    1 / 36 (2.78%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 36 (2.78%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune-mediated hepatitis
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 36 (2.78%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 36 (2.78%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toxic skin eruption
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Neck pain
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 114 (1.75%)
    1 / 36 (2.78%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 114 (2.63%)
    1 / 36 (2.78%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    3 / 114 (2.63%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 36 (2.78%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    2 / 114 (1.75%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 36 (0.00%)
    2 / 37 (5.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Achromobacter infection
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocarditis enterococcal
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Large intestine infection
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural infection
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostate infection
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypercalcaemia
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 36 (0.00%)
    2 / 37 (5.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 36 (2.78%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Part A: 1st Line NSCLC Part B: 2nd line NSCLC Part C: 2nd line HNSCC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    114 / 114 (100.00%)
    35 / 36 (97.22%)
    36 / 37 (97.30%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    6 / 114 (5.26%)
    1 / 36 (2.78%)
    3 / 37 (8.11%)
         occurrences all number
    8
    1
    5
    Vascular disorders
    Hypotension
         subjects affected / exposed
    6 / 114 (5.26%)
    0 / 36 (0.00%)
    4 / 37 (10.81%)
         occurrences all number
    7
    0
    5
    Hypertension
         subjects affected / exposed
    6 / 114 (5.26%)
    0 / 36 (0.00%)
    3 / 37 (8.11%)
         occurrences all number
    6
    0
    8
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    39 / 114 (34.21%)
    8 / 36 (22.22%)
    8 / 37 (21.62%)
         occurrences all number
    91
    14
    12
    Fatigue
         subjects affected / exposed
    26 / 114 (22.81%)
    8 / 36 (22.22%)
    6 / 37 (16.22%)
         occurrences all number
    47
    11
    11
    Pyrexia
         subjects affected / exposed
    17 / 114 (14.91%)
    2 / 36 (5.56%)
    2 / 37 (5.41%)
         occurrences all number
    24
    5
    2
    Oedema peripheral
         subjects affected / exposed
    11 / 114 (9.65%)
    6 / 36 (16.67%)
    0 / 37 (0.00%)
         occurrences all number
    20
    6
    0
    Injection site pain
         subjects affected / exposed
    10 / 114 (8.77%)
    5 / 36 (13.89%)
    0 / 37 (0.00%)
         occurrences all number
    38
    9
    0
    Non-cardiac chest pain
         subjects affected / exposed
    10 / 114 (8.77%)
    5 / 36 (13.89%)
    0 / 37 (0.00%)
         occurrences all number
    12
    6
    0
    Injection site erythema
         subjects affected / exposed
    8 / 114 (7.02%)
    5 / 36 (13.89%)
    0 / 37 (0.00%)
         occurrences all number
    14
    17
    0
    Injection site reaction
         subjects affected / exposed
    7 / 114 (6.14%)
    4 / 36 (11.11%)
    0 / 37 (0.00%)
         occurrences all number
    28
    4
    0
    Injection site swelling
         subjects affected / exposed
    4 / 114 (3.51%)
    3 / 36 (8.33%)
    0 / 37 (0.00%)
         occurrences all number
    6
    3
    0
    Injection site pruritus
         subjects affected / exposed
    4 / 114 (3.51%)
    2 / 36 (5.56%)
    0 / 37 (0.00%)
         occurrences all number
    11
    2
    0
    Malaise
         subjects affected / exposed
    2 / 114 (1.75%)
    3 / 36 (8.33%)
    0 / 37 (0.00%)
         occurrences all number
    2
    3
    0
    Chest pain
         subjects affected / exposed
    1 / 114 (0.88%)
    2 / 36 (5.56%)
    0 / 37 (0.00%)
         occurrences all number
    1
    2
    0
    Facial pain
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    1
    0
    2
    Pain
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    1
    0
    2
    Face oedema
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 36 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    0
    4
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    39 / 114 (34.21%)
    13 / 36 (36.11%)
    3 / 37 (8.11%)
         occurrences all number
    64
    18
    4
    Cough
         subjects affected / exposed
    34 / 114 (29.82%)
    11 / 36 (30.56%)
    7 / 37 (18.92%)
         occurrences all number
    54
    12
    10
    Haemoptysis
         subjects affected / exposed
    15 / 114 (13.16%)
    1 / 36 (2.78%)
    2 / 37 (5.41%)
         occurrences all number
    22
    1
    2
    Productive cough
         subjects affected / exposed
    12 / 114 (10.53%)
    3 / 36 (8.33%)
    0 / 37 (0.00%)
         occurrences all number
    19
    3
    0
    Dysphonia
         subjects affected / exposed
    3 / 114 (2.63%)
    2 / 36 (5.56%)
    2 / 37 (5.41%)
         occurrences all number
    3
    3
    2
    Dyspnoea exertional
         subjects affected / exposed
    2 / 114 (1.75%)
    2 / 36 (5.56%)
    0 / 37 (0.00%)
         occurrences all number
    2
    2
    0
    Wheezing
         subjects affected / exposed
    1 / 114 (0.88%)
    2 / 36 (5.56%)
    0 / 37 (0.00%)
         occurrences all number
    1
    2
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    11 / 114 (9.65%)
    2 / 36 (5.56%)
    1 / 37 (2.70%)
         occurrences all number
    14
    2
    1
    Investigations
    Weight decreased
         subjects affected / exposed
    6 / 114 (5.26%)
    6 / 36 (16.67%)
    7 / 37 (18.92%)
         occurrences all number
    9
    6
    7
    Amylase increased
         subjects affected / exposed
    13 / 114 (11.40%)
    3 / 36 (8.33%)
    1 / 37 (2.70%)
         occurrences all number
    24
    8
    4
    Aspartate aminotransferase increased
         subjects affected / exposed
    6 / 114 (5.26%)
    3 / 36 (8.33%)
    3 / 37 (8.11%)
         occurrences all number
    6
    3
    4
    Alanine aminotransferase increased
         subjects affected / exposed
    7 / 114 (6.14%)
    2 / 36 (5.56%)
    1 / 37 (2.70%)
         occurrences all number
    11
    2
    1
    Blood creatine increased
         subjects affected / exposed
    7 / 114 (6.14%)
    1 / 36 (2.78%)
    0 / 37 (0.00%)
         occurrences all number
    9
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    5 / 114 (4.39%)
    2 / 36 (5.56%)
    0 / 37 (0.00%)
         occurrences all number
    7
    2
    0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    1 / 114 (0.88%)
    2 / 36 (5.56%)
    0 / 37 (0.00%)
         occurrences all number
    1
    2
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    7 / 114 (6.14%)
    4 / 36 (11.11%)
    2 / 37 (5.41%)
         occurrences all number
    9
    4
    2
    Headache
         subjects affected / exposed
    7 / 114 (6.14%)
    4 / 36 (11.11%)
    2 / 37 (5.41%)
         occurrences all number
    7
    4
    2
    Paraesthesia
         subjects affected / exposed
    4 / 114 (3.51%)
    2 / 36 (5.56%)
    0 / 37 (0.00%)
         occurrences all number
    5
    2
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    28 / 114 (24.56%)
    1 / 36 (2.78%)
    7 / 37 (18.92%)
         occurrences all number
    46
    5
    9
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    19 / 114 (16.67%)
    6 / 36 (16.67%)
    4 / 37 (10.81%)
         occurrences all number
    28
    9
    5
    Diarrhoea
         subjects affected / exposed
    20 / 114 (17.54%)
    3 / 36 (8.33%)
    5 / 37 (13.51%)
         occurrences all number
    38
    3
    8
    Constipation
         subjects affected / exposed
    21 / 114 (18.42%)
    4 / 36 (11.11%)
    2 / 37 (5.41%)
         occurrences all number
    31
    7
    2
    Vomiting
         subjects affected / exposed
    13 / 114 (11.40%)
    5 / 36 (13.89%)
    3 / 37 (8.11%)
         occurrences all number
    16
    6
    3
    Abdominal pain
         subjects affected / exposed
    6 / 114 (5.26%)
    3 / 36 (8.33%)
    2 / 37 (5.41%)
         occurrences all number
    8
    7
    2
    Abdominal pain upper
         subjects affected / exposed
    7 / 114 (6.14%)
    2 / 36 (5.56%)
    0 / 37 (0.00%)
         occurrences all number
    8
    2
    0
    Dysphagia
         subjects affected / exposed
    7 / 114 (6.14%)
    1 / 36 (2.78%)
    1 / 37 (2.70%)
         occurrences all number
    8
    1
    2
    Stomatitis
         subjects affected / exposed
    2 / 114 (1.75%)
    1 / 36 (2.78%)
    4 / 37 (10.81%)
         occurrences all number
    3
    1
    5
    Dry mouth
         subjects affected / exposed
    6 / 114 (5.26%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    12
    0
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    27 / 114 (23.68%)
    5 / 36 (13.89%)
    4 / 37 (10.81%)
         occurrences all number
    60
    7
    6
    Rash
         subjects affected / exposed
    18 / 114 (15.79%)
    0 / 36 (0.00%)
    3 / 37 (8.11%)
         occurrences all number
    46
    0
    4
    Dry skin
         subjects affected / exposed
    9 / 114 (7.89%)
    2 / 36 (5.56%)
    2 / 37 (5.41%)
         occurrences all number
    11
    2
    2
    Rash erythematous
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    2
    0
    2
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 36 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    0
    2
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    11 / 114 (9.65%)
    1 / 36 (2.78%)
    7 / 37 (18.92%)
         occurrences all number
    11
    1
    9
    Hyperthyroidism
         subjects affected / exposed
    7 / 114 (6.14%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    8
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    19 / 114 (16.67%)
    7 / 36 (19.44%)
    4 / 37 (10.81%)
         occurrences all number
    29
    8
    10
    Back pain
         subjects affected / exposed
    15 / 114 (13.16%)
    3 / 36 (8.33%)
    5 / 37 (13.51%)
         occurrences all number
    30
    3
    7
    Musculoskeletal pain
         subjects affected / exposed
    13 / 114 (11.40%)
    4 / 36 (11.11%)
    2 / 37 (5.41%)
         occurrences all number
    18
    4
    2
    Neck pain
         subjects affected / exposed
    8 / 114 (7.02%)
    1 / 36 (2.78%)
    3 / 37 (8.11%)
         occurrences all number
    9
    1
    3
    Pain in extremity
         subjects affected / exposed
    8 / 114 (7.02%)
    1 / 36 (2.78%)
    2 / 37 (5.41%)
         occurrences all number
    15
    1
    2
    Musculoskeletal chest pain
         subjects affected / exposed
    6 / 114 (5.26%)
    3 / 36 (8.33%)
    0 / 37 (0.00%)
         occurrences all number
    6
    3
    0
    Myalgia
         subjects affected / exposed
    8 / 114 (7.02%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    11
    0
    0
    Pain in jaw
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    1
    0
    4
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    8 / 114 (7.02%)
    2 / 36 (5.56%)
    2 / 37 (5.41%)
         occurrences all number
    10
    5
    3
    COVID-19
         subjects affected / exposed
    8 / 114 (7.02%)
    2 / 36 (5.56%)
    1 / 37 (2.70%)
         occurrences all number
    9
    2
    1
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 114 (4.39%)
    3 / 36 (8.33%)
    4 / 37 (10.81%)
         occurrences all number
    5
    3
    4
    Urinary tract infection
         subjects affected / exposed
    7 / 114 (6.14%)
    1 / 36 (2.78%)
    3 / 37 (8.11%)
         occurrences all number
    9
    1
    3
    Respiratory tract infection
         subjects affected / exposed
    5 / 114 (4.39%)
    1 / 36 (2.78%)
    2 / 37 (5.41%)
         occurrences all number
    5
    1
    3
    Bronchitis
         subjects affected / exposed
    4 / 114 (3.51%)
    1 / 36 (2.78%)
    2 / 37 (5.41%)
         occurrences all number
    6
    1
    2
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 114 (2.63%)
    2 / 36 (5.56%)
    1 / 37 (2.70%)
         occurrences all number
    4
    3
    1
    Oral candidiasis
         subjects affected / exposed
    4 / 114 (3.51%)
    1 / 36 (2.78%)
    2 / 37 (5.41%)
         occurrences all number
    6
    1
    2
    Nasopharyngitis
         subjects affected / exposed
    6 / 114 (5.26%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    9
    0
    0
    Rhinitis
         subjects affected / exposed
    3 / 114 (2.63%)
    2 / 36 (5.56%)
    0 / 37 (0.00%)
         occurrences all number
    6
    3
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    30 / 114 (26.32%)
    13 / 36 (36.11%)
    4 / 37 (10.81%)
         occurrences all number
    40
    14
    4
    Hyperglycaemia
         subjects affected / exposed
    9 / 114 (7.89%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    12
    0
    0
    Hypercalcaemia
         subjects affected / exposed
    3 / 114 (2.63%)
    2 / 36 (5.56%)
    1 / 37 (2.70%)
         occurrences all number
    4
    3
    2
    Hyponatraemia
         subjects affected / exposed
    4 / 114 (3.51%)
    3 / 36 (8.33%)
    1 / 37 (2.70%)
         occurrences all number
    6
    5
    2
    Hyperkalaemia
         subjects affected / exposed
    6 / 114 (5.26%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    7
    0
    0
    Dehydration
         subjects affected / exposed
    2 / 114 (1.75%)
    1 / 36 (2.78%)
    2 / 37 (5.41%)
         occurrences all number
    2
    1
    2
    Hypokalaemia
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 36 (2.78%)
    2 / 37 (5.41%)
         occurrences all number
    1
    1
    2
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 36 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    1
    0
    3
    Hypomagnesaemia
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 36 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    0
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Jan 2019
    • Update on pembrolizumab’s relevant approved indication • Update of clinical data of eftilagimod alpha • Study Stopping Rules updated according to CA comments • Inclusion criteria updated to specify NSCLC patient population eligible for the study e.g. clarification on the prior use of durvalumab • Exclusion criteria updated #´specifing NSCLC patient population e.g. clarification on the wash-out for patients receiving pembrolizumab and clarification on the definition/detection of hepatitis • Additional safety data added and update of related risk language • Update to management and discontinuation guidelines
    28 Jul 2020
    • Part A cohort extension • Clarifications regarding Part B patient selection and inclusion exclusion criteria • Clarification on rules of efti treatment delay and allowed study treatment interruptions • Update to pembrolizumab dose modification rules • Clarification on patient rescreening, pregnancy testing and laboratory analyses used for tumour tissue • Additions to allow for adapting to COVID-19, replacement of patients who discontinue early due to COVID, remote monitoring under special circumstances • PK sampling window extended for late PK timepoints • Clarification on interim analyses and timing
    08 Jun 2021
    • Update to Sponsor's address and other contact details • Clarification to reporting deadline for Events of Clinical Interest
    18 Aug 2023
    • Update on study timelines, extending study end by 12 month to collect additional PFS/OS FU data

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Limitations include lack of randomization and a control group, and a small sample size
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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