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    Clinical Trial Results:
    A RANDOMIZED, PHASE 2, DOUBLE-BLIND STUDY TO EVALUATE THE EFFICACY OF DOSTARLIMAB PLUS CHEMOTHERAPY VERSUS PEMBROLIZUMAB PLUS CHEMOTHERAPY IN METASTATIC NON-SQUAMOUS NON-SMALL CELL LUNG CANCER

    Summary
    EudraCT number
    		 2020-002327-11
    Trial protocol
    		 DE   FR   IT   RO  
    Global end of trial date

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Aug 2023
    First version publication date
    18 Aug 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    213403
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04581824
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom, TW8 9GS
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.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
    Interim
    Date of interim/final analysis
    22 Sep 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Aug 2022
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    To compare the ORR of PD-1 inhibitor dostarlimab vs pembrolizumab administered in combination with chemotherapy as evaluated using RECIST v1.1 based on BICR in participants with metastatic non-squamous NSCLC, without a known EGFR, ALK, ROS-1, or BRAF V600E mutation or other genomic aberration for which a targeted therapy is available, who have received no prior treatment of metastatic disease.
    Protection of trial subjects
    Not Applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Nov 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 40
    Country: Number of subjects enrolled
    Brazil: 27
    Country: Number of subjects enrolled
    Chile: 2
    Country: Number of subjects enrolled
    France: 15
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    Italy: 25
    Country: Number of subjects enrolled
    Korea, Republic of: 40
    Country: Number of subjects enrolled
    Poland: 28
    Country: Number of subjects enrolled
    Romania: 10
    Country: Number of subjects enrolled
    Spain: 41
    Country: Number of subjects enrolled
    Taiwan: 4
    Country: Number of subjects enrolled
    United States: 3
    Worldwide total number of subjects
    243
    EEA total number of subjects
    127
    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)
    122
    From 65 to 84 years
    121
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The results presented are till the primary completion date. Data collection is still ongoing and additional results will be provided after study completion.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind [1]
    Roles blinded
    		 Subject, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dostarlimab + Chemotherapy
    Arm description
    		 Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received Dostarlimab and Chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of Dostarlimab was administered as 30-minute intravenous (IV) infusion of as every three weeks (Q3W). 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cisplatin was administered at 75 mg/m^2 through a 30 minute IV infusion Q3W for 4 cycles (each cycle of 21 days) as per investigator decision.

    Investigational medicinal product name
    Dostarlimab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dostarlimab will be administered through a 30 minute infusion at a dose of 500 milligrams (mg) intravenously (IV) every 3 weeks (Q3W) up to a maximum of 35 cycles (each cycle of 21 days).

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin was administered at area under the concentration time curve 5 milligram/milliliters/minute (mg/mL/min) (maximum dose: 750 mg) through a 15 to 60 minute IV infusion Q3W for 4 cycles (each cycle of 21 days) as per investigator decision.

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Pemetrexed was administered at 500 milligram per meter square (mg/m^2) IV through a 10 minute IV infusion Q3W, up to a maximum of 35 cycles (each cycle of 21 days).

    Arm title
    		 Pembrolizumab + Chemotherapy
    Arm description
    		 Participants with metastatic NSCLC received Pembrolizumab and Chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: Pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of Pembrolizumab was administered as 30-minute IV infusion Q3W. 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Pembrolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Pembrolizumab was administered through a 30 minute infusion at a dose of 200 mg Q3W up to a maximum of 35 cycles (each cycle of 21 days).

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cisplatin was administered at 75 mg/m^2 through a 30 minute IV infusion Q3W for 4 cycles (each cycle of 21 days) as per investigator decision.

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin was administered at area under the concentration time curve 5 milligram/milliliters/minute (mg/mL/min) (maximum dose: 750 mg) through a 15 to 60 minute IV infusion Q3W for 4 cycles (each cycle of 21 days) as per investigator decision.

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Pemetrexed was administered at 500 milligram per meter square (mg/m^2) IV through a 10 minute IV infusion Q3W, up to a maximum of 35 cycles (each cycle of 21 days).

    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: Study design required to keep the Subject and Caregiver blinded
    Number of subjects in period 1
    		Dostarlimab + Chemotherapy Pembrolizumab + Chemotherapy
    Started
    121
    122
    Completed
    42
    48
    Not completed
    79
    74
         Consent withdrawn by subject
    3
    5
         Ongoing
    75
    69
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dostarlimab + Chemotherapy
    Reporting group description
    		 Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received Dostarlimab and Chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of Dostarlimab was administered as 30-minute intravenous (IV) infusion of as every three weeks (Q3W). 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.

    Reporting group title
    Pembrolizumab + Chemotherapy
    Reporting group description
    		 Participants with metastatic NSCLC received Pembrolizumab and Chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: Pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of Pembrolizumab was administered as 30-minute IV infusion Q3W. 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.

    Reporting group values
    		 Dostarlimab + Chemotherapy Pembrolizumab + Chemotherapy Total
    Number of subjects
    		 121 122 243
    Age categorical
    Units: Subjects
        <=18 years
    		 0 0 0
        19-64 years
    		 65 57 122
        >=65 years
    		 56 65 121
    Age continuous
    Units: years
        median (full range (min-max))
    		 64.0 (25 to 80) 65.0 (46 to 86) -
    Sex: Female, Male
    Units: Participants
        Female
    		 36 45 81
        Male
    		 85 77 162
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian or Alaska Native
    		 1 0 1
        Asian
    		 23 21 44
        Black or African American
    		 1 3 4
        White
    		 87 84 171
        Multiple
    		 3 3 6
        Not Reported
    		 2 5 7
        Unknown
    		 4 6 10
    Age, Continuous
    Units: YEARS
        arithmetic mean (standard deviation)
    		 63.4 ± 9.43 65.4 ± 8.51 -

    End points

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    End points reporting groups
    Reporting group title
    Dostarlimab + Chemotherapy
    Reporting group description
    		 Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received Dostarlimab and Chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of Dostarlimab was administered as 30-minute intravenous (IV) infusion of as every three weeks (Q3W). 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.

    Reporting group title
    Pembrolizumab + Chemotherapy
    Reporting group description
    		 Participants with metastatic NSCLC received Pembrolizumab and Chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: Pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of Pembrolizumab was administered as 30-minute IV infusion Q3W. 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.

    Primary: Overall response rate (ORR)

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    End point title
    		 Overall response rate (ORR)
    End point description
    ORR per response was defined as the percentage of participants who had a confirmed complete response (CR) or confirmed partial response (PR) as their best overall response (BOR ) recorded from the date of randomization until disease progression or initiation of new anti-cancer therapy, whichever is earlier based on blinded independent central review (BICR) evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeter in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters (e.g., percent change from baseline).
    End point type
    Primary
    End point timeframe
    Up to approximately 20 months
    End point values
    		 Dostarlimab + Chemotherapy Pembrolizumab + Chemotherapy
    Number of subjects analysed
    121
    122
    Units: Percentage of Participants
        number (confidence interval 95%)
    46 (37.2 to 55.6)
    37 (28.3 to 46.1)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Dostarlimab + Chemotherapy v Pembrolizumab + Chemotherapy
    Number of subjects included in analysis
    243
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Difference in Response Rate
    Point estimate
    9.32
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 1.46
         upper limit
    		 17.18

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 20 months.
    Adverse event reporting additional description
    Safety population included all participants who received at least 1 dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 V 25.0
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Pembrolizumab + Chemotherapy
    Reporting group description
    		 Participants with metastatic NSCLC received Pembrolizumab and Chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: Pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of Pembrolizumab was administered as 30-minute IV infusion Q3W. 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.

    Reporting group title
    Dostarlimab + Chemotherapy
    Reporting group description
    		 Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received Dostarlimab and Chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of Dostarlimab was administered as 30-minute intravenous (IV) infusion of as every three weeks (Q3W). 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.

    Serious adverse events
    		 Pembrolizumab + Chemotherapy Dostarlimab + Chemotherapy
    Total subjects affected by serious adverse events
         subjects affected / exposed
    55 / 122 (45.08%)
    46 / 121 (38.02%)
         number of deaths (all causes)
    48
    42
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Gastrointestinal neoplasm
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cancer pain
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral artery stenosis
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 122 (0.82%)
    3 / 121 (2.48%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disease progression
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pain
         subjects affected / exposed
    0 / 122 (0.00%)
    2 / 121 (1.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    4 / 122 (3.28%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    3 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Sudden death
         subjects affected / exposed
    0 / 122 (0.00%)
    2 / 121 (1.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    3 / 122 (2.46%)
    5 / 121 (4.13%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    2 / 122 (1.64%)
    2 / 121 (1.65%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspiration
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    2 / 122 (1.64%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    2 / 122 (1.64%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 122 (0.82%)
    2 / 121 (1.65%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonitis
         subjects affected / exposed
    5 / 122 (4.10%)
    3 / 121 (2.48%)
         occurrences causally related to treatment / all
    5 / 5
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Pleural effusion
         subjects affected / exposed
    1 / 122 (0.82%)
    4 / 121 (3.31%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune-mediated lung disease
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 122 (0.82%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    2 / 122 (1.64%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical condition abnormal
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Gastroenteritis radiation
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    2 / 122 (1.64%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    2 / 122 (1.64%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Seizure
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysarthria
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient aphasia
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 122 (4.10%)
    8 / 121 (6.61%)
         occurrences causally related to treatment / all
    6 / 6
    9 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    4 / 122 (3.28%)
    4 / 121 (3.31%)
         occurrences causally related to treatment / all
    4 / 4
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    3 / 122 (2.46%)
    3 / 121 (2.48%)
         occurrences causally related to treatment / all
    3 / 3
    3 / 3
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Neutropenia
         subjects affected / exposed
    3 / 122 (2.46%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelosuppression
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    2 / 122 (1.64%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    2 / 122 (1.64%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 122 (1.64%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angioedema
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    1 / 122 (0.82%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    COVID-19
         subjects affected / exposed
    0 / 122 (0.00%)
    4 / 121 (3.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia
         subjects affected / exposed
    12 / 122 (9.84%)
    4 / 121 (3.31%)
         occurrences causally related to treatment / all
    2 / 12
    2 / 4
         deaths causally related to treatment / all
    1 / 4
    0 / 1
    Pulmonary sepsis
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory tract infection
         subjects affected / exposed
    1 / 122 (0.82%)
    3 / 121 (2.48%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 122 (1.64%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 122 (0.82%)
    2 / 121 (1.65%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    1 / 1
    0 / 2
    Strongyloidiasis
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Viral infection
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    2 / 122 (1.64%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pembrolizumab + Chemotherapy Dostarlimab + Chemotherapy
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    110 / 122 (90.16%)
    114 / 121 (94.21%)
    Investigations
    Weight decreased
         subjects affected / exposed
    6 / 122 (4.92%)
    7 / 121 (5.79%)
         occurrences all number
    6
    9
    Platelet count decreased
         subjects affected / exposed
    9 / 122 (7.38%)
    2 / 121 (1.65%)
         occurrences all number
    17
    2
    Blood creatinine increased
         subjects affected / exposed
    6 / 122 (4.92%)
    13 / 121 (10.74%)
         occurrences all number
    7
    15
    Blood alkaline phosphatase increased
         subjects affected / exposed
    7 / 122 (5.74%)
    5 / 121 (4.13%)
         occurrences all number
    8
    6
    Aspartate aminotransferase increased
         subjects affected / exposed
    8 / 122 (6.56%)
    9 / 121 (7.44%)
         occurrences all number
    13
    14
    Alanine aminotransferase increased
         subjects affected / exposed
    13 / 122 (10.66%)
    11 / 121 (9.09%)
         occurrences all number
    21
    14
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 122 (6.56%)
    7 / 121 (5.79%)
         occurrences all number
    9
    11
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    57 / 122 (46.72%)
    55 / 121 (45.45%)
         occurrences all number
    121
    151
    Neutropenia
         subjects affected / exposed
    25 / 122 (20.49%)
    16 / 121 (13.22%)
         occurrences all number
    36
    28
    Thrombocytopenia
         subjects affected / exposed
    9 / 122 (7.38%)
    13 / 121 (10.74%)
         occurrences all number
    14
    28
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    3 / 122 (2.46%)
    7 / 121 (5.79%)
         occurrences all number
    3
    8
    Oedema peripheral
         subjects affected / exposed
    9 / 122 (7.38%)
    8 / 121 (6.61%)
         occurrences all number
    11
    8
    Mucosal inflammation
         subjects affected / exposed
    7 / 122 (5.74%)
    7 / 121 (5.79%)
         occurrences all number
    10
    8
    Fatigue
         subjects affected / exposed
    12 / 122 (9.84%)
    14 / 121 (11.57%)
         occurrences all number
    16
    26
    Chest pain
         subjects affected / exposed
    7 / 122 (5.74%)
    3 / 121 (2.48%)
         occurrences all number
    8
    3
    Asthenia
         subjects affected / exposed
    40 / 122 (32.79%)
    38 / 121 (31.40%)
         occurrences all number
    69
    74
    Pyrexia
         subjects affected / exposed
    12 / 122 (9.84%)
    12 / 121 (9.92%)
         occurrences all number
    19
    15
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    14 / 122 (11.48%)
    20 / 121 (16.53%)
         occurrences all number
    18
    29
    Stomatitis
         subjects affected / exposed
    5 / 122 (4.10%)
    7 / 121 (5.79%)
         occurrences all number
    5
    8
    Nausea
         subjects affected / exposed
    29 / 122 (23.77%)
    28 / 121 (23.14%)
         occurrences all number
    56
    65
    Diarrhoea
         subjects affected / exposed
    15 / 122 (12.30%)
    15 / 121 (12.40%)
         occurrences all number
    18
    21
    Constipation
         subjects affected / exposed
    22 / 122 (18.03%)
    22 / 121 (18.18%)
         occurrences all number
    27
    33
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    19 / 122 (15.57%)
    19 / 121 (15.70%)
         occurrences all number
    29
    30
    Cough
         subjects affected / exposed
    20 / 122 (16.39%)
    22 / 121 (18.18%)
         occurrences all number
    25
    24
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    10 / 122 (8.20%)
    8 / 121 (6.61%)
         occurrences all number
    10
    12
    Rash
         subjects affected / exposed
    6 / 122 (4.92%)
    15 / 121 (12.40%)
         occurrences all number
    6
    15
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    5 / 122 (4.10%)
    10 / 121 (8.26%)
         occurrences all number
    5
    12
    Hyperthyroidism
         subjects affected / exposed
    2 / 122 (1.64%)
    7 / 121 (5.79%)
         occurrences all number
    3
    10
    Musculoskeletal and connective tissue disorders
    Musculoskeletal chest pain
         subjects affected / exposed
    7 / 122 (5.74%)
    3 / 121 (2.48%)
         occurrences all number
    8
    3
    Back pain
         subjects affected / exposed
    14 / 122 (11.48%)
    7 / 121 (5.79%)
         occurrences all number
    15
    7
    Arthralgia
         subjects affected / exposed
    9 / 122 (7.38%)
    7 / 121 (5.79%)
         occurrences all number
    9
    11
    Infections and infestations
    Respiratory tract infection
         subjects affected / exposed
    9 / 122 (7.38%)
    6 / 121 (4.96%)
         occurrences all number
    9
    7
    Pneumonia
         subjects affected / exposed
    6 / 122 (4.92%)
    7 / 121 (5.79%)
         occurrences all number
    6
    9
    Metabolism and nutrition disorders
    Hypomagnesaemia
         subjects affected / exposed
    8 / 122 (6.56%)
    8 / 121 (6.61%)
         occurrences all number
    12
    13
    Hyperglycaemia
         subjects affected / exposed
    8 / 122 (6.56%)
    7 / 121 (5.79%)
         occurrences all number
    10
    7
    Decreased appetite
         subjects affected / exposed
    16 / 122 (13.11%)
    19 / 121 (15.70%)
         occurrences all number
    18
    25

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jul 2020
    Created in response to Health Authority feedback to modify the disease eligibility criterion.
    10 Sep 2020
    Created in response to Health Authority feedback to modify the contraception eligibility criterion and the chemotherapy study treatments section to ensure that the protocol instructions take local labeling variability into account regarding chemotherapeutic agents.
    17 Jun 2021
    Intended to provide a number of clarifications to aspects of the study conduct.
    30 Nov 2021
    Intended to allow better study accessibility to patients and to ensure good enrollment rate by lifting the requirement to completely fill 3 TPS stratification cohorts. Per protocol, patients are stratified into 3 TPS cohorts <1%, 1-49% and >50% PD-L1 expression. Additional minor updates to the management of immunotherapy related AEs were done to align with dostarlimab program.
    14 Feb 2023
    Intended to allow a better characterization of study efficacy endpoints.

    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.
    None reported
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    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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