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    Clinical Trial Results:
    A multicentre single-arm phase II trial assessing the safety and efficacy of first-line osimertinib and locally ablative radiotherapy in patients with synchronous oligo-metastatic EGFR-mutant non-small cell lung cancer

    Summary
    EudraCT number
    		 2020-004114-35
    Trial protocol
    		 ES   IT   NL  
    Global end of trial date
    29 Feb 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Oct 2025
    First version publication date
    23 Oct 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ETOP17-20
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04908956
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 AstraZeneca Number: ESR-19-20384
    Sponsors
    Sponsor organisation name
    ETOP IBCSG Partners Foundation
    Sponsor organisation address
    Effingerstrasse 33 , Bern, Switzerland, 3008
    Public contact
    ETOP Coordinating Center, ETOP IBCSG Partners Foundation, +41 315119400, etop-regulatory@etop.ibcsg.org
    Scientific contact
    ETOP Coordinating Center, ETOP IBCSG Partners Foundation, +41 315119400, etop-regulatory@etop.ibcsg.org
    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
    07 Mar 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Feb 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this trial is to evaluate safety (in terms of grade ≥2 pneumonitis, requiring medical treatment) and efficacy (in terms of PFS) in patients with synchronous oligo-metastatic EGFR-mutant NSCLC treated with osimertinib and locally ablative radiotherapy to all cancer sites.
    Protection of trial subjects
    Participating institutions’ ethics committees or Institutional Review Boards approved the trial according to local laws and regulations. All patients gave written informed consent, and the trial was performed in compliance with the Helsinki Declaration. The Data Safety and Monitoring Board reviewed the data from this research throughout the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Jan 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 4
    Country: Number of subjects enrolled
    Spain: 2
    Worldwide total number of subjects
    6
    EEA total number of subjects
    2
    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)
    2
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 There were 2 screening failures.

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

    Arms
    Arm title
    		 Osimertinib
    Arm description
    		 Osimertinib, 80 mg once daily p.o., until progression or unacceptable toxicity + locally ablative radiotherapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    Osimertinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    80mg once daily p.o. until progression or unacceptable toxicity

    Number of subjects in period 1
    		Osimertinib
    Started
    6
    Completed
    0
    Not completed
    6
         Early termination of trial
    5
         Treatment failure
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 -

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 6 6
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 70 (49 to 75) -
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    Osimertinib
    Reporting group description
    		 Osimertinib, 80 mg once daily p.o., until progression or unacceptable toxicity + locally ablative radiotherapy

    Primary: Rate of grade ≥2 pneumonitis requiring medical treatment

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    End point title
    		 Rate of grade ≥2 pneumonitis requiring medical treatment [1]
    End point description
    Rate of grade ≥2 pneumonitis, requiring medical treatment, observed any time during the first 18 months of follow-up from enrolment, in the primary-endpoint safety cohort. If safety is proven, efficacy will be hierarchically tested in terms of PFS according to RECIST v1.1, in the efficacy cohort.
    End point type
    Primary
    End point timeframe
    During the first 18 months of follow-up from enrolment.
    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 analysis was perfomed due to early termination
    End point values
    		 Osimertinib
    Number of subjects analysed
    0 [2]
    Units: Participant
    Notes
    [2] - End point not met as trial was terminated prematurely
    No statistical analyses for this end point

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    Overall survival (OS) is defined as the time from the date of enrolment until death from any cause. Censoring will occur at the last follow-up date.
    End point type
    Secondary
    End point timeframe
    From the date of enrolment until death from any cause.
    End point values
    		 Osimertinib
    Number of subjects analysed
    0 [3]
    Units: month
        median (confidence interval 95%)
    ( to )
    Notes
    [3] - no data due to early termination
    No statistical analyses for this end point

    Secondary: Pattern of disease progression

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    End point title
    		 Pattern of disease progression
    End point description
    The pattern of disease progression is defined as the site of first progression: None, locoregional, distant (bone, brain, liver, etc.) or both locoregional and distant, evaluated up to 18-months post enrolment.
    End point type
    Secondary
    End point timeframe
    Up to 18-months post enrolment
    End point values
    		 Osimertinib
    Number of subjects analysed
    0 [4]
    Units: descriptive or qualitative endpoint
    Notes
    [4] - no data due to early termination of trial
    No statistical analyses for this end point

    Secondary: Distant progression-free survival

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    End point title
    		 Distant progression-free survival
    End point description
    Distant PFS is defined as the time from date of enrolment until development of new metastases, excluding oligo-metastases diagnosed at enrolment.
    End point type
    Secondary
    End point timeframe
    From date of enrolment until development of new metastases
    End point values
    		 Osimertinib
    Number of subjects analysed
    0 [5]
    Units: month
        median (confidence interval 95%)
    ( to )
    Notes
    [5] - no data due to early termination
    No statistical analyses for this end point

    Secondary: Objective response rate

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    End point title
    		 Objective response rate
    End point description
    Objective response rate (ORR) is defined as the percentage of patients that achieve a best overall response [complete response (CR) or partial response (PR)] according to RECIST v1.1 from enrolment across all trial assessment time-points.
    End point type
    Secondary
    End point timeframe
    From enrolment across all trial assessment time-points.
    End point values
    		 Osimertinib
    Number of subjects analysed
    0 [6]
    Units: Participant
    Notes
    [6] - no data due to early termination
    No statistical analyses for this end point

    Secondary: Duration of response

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    End point title
    		 Duration of response
    End point description
    Duration of Response (DoR) is defined as the interval from the date of first documentation of objective response (CR or PR, according to RECIST v1.1) to the date of first documented progression, relapse or death.
    End point type
    Secondary
    End point timeframe
    From the date of first documentation of objective response to the date of first documented progression, relapse or death.
    End point values
    		 Osimertinib
    Number of subjects analysed
    0 [7]
    Units: month
        median (confidence interval 95%)
    ( to )
    Notes
    [7] - no data due to early termination
    No statistical analyses for this end point

    Secondary: Toxicity

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    End point title
    		 Toxicity
    End point description
    All safety parameters will be summarised in tables to evaluate the safety profile of the protocol treatment in terms of: - Adverse events according to CTCAE v5.0 including adverse events leading to dose interruptions, withdrawal of protocol treatment, and death - Severe, serious, and selected adverse events - Deaths - Laboratory parameters and abnormalities, and vital signs
    End point type
    Secondary
    End point timeframe
    from the date of enrolment
    End point values
    		 Osimertinib
    Number of subjects analysed
    0 [8]
    Units: Participant
    Notes
    [8] - all available data is listed in adverse events section
    No statistical analyses for this end point

    Secondary: Symptom-specific and global Quality of Life

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    End point title
    		 Symptom-specific and global Quality of Life
    End point description
    QoL will be assessed by the Lung Cancer Symptom Scale, a 9-item questionnaire including six symptoms (i.e., appetite loss, fatigue, cough, dyspnoea, haemoptysis and pain) and three items addressing symptomatic distress, normal activity, and global QoL. The primary QoL endpoints will be the change in the LCSS total score (average of all 9 items) from baseline to 24 weeks on treatment.
    End point type
    Secondary
    End point timeframe
    From baseline to 24 weeks on treatment.
    End point values
    		 Osimertinib
    Number of subjects analysed
    0 [9]
    Units: number
        number (not applicable)
    Notes
    [9] - no data available due to early termination
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the date of enrolment until 6 weeks after all protocol treatment discontinuation, regardless of whether it is considered related to a medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5.0
    Reporting groups
    Reporting group title
    Osimertinib
    Reporting group description
    		 -

    Serious adverse events
    		 Osimertinib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 6 (16.67%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    Respiratory, thoracic and mediastinal disorders
    Pneumoperitoneum
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Osimertinib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 6 (83.33%)
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Serum amylase increased
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Vascular disorders
    Thromboembolic event
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    General disorders and administration site conditions
    Edema limbs
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    2
    Constipation
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    2
    Hemorrhoidal hemorrhage
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Mucositis oral
         subjects affected / exposed
    3 / 6 (50.00%)
         occurrences all number
    3
    Esophagitis
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Upper tract respiratory infection
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Cough
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Nasal congestion
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Rhinorrhea
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Rash acneiform
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Urticaria
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Infections and infestations
    Covid-19 infection
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Folliculitis
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Paronychia
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Apr 2022
    The protocol has been updated to account account for the sponsor change from ETOP to ETOP IBCSG partners. In addition, aplastic anaemia has been added as new safety risk, as well as some clarifications on the management of patients with past or chronic hepatitis Revised documents – Working protocol – Synopsis – Patient information and informed consent (revised) – Patient card, patient diary, pregnant partner informed consent form, withdrawal of consent form, letter to general practitioner

    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.
    The trial struggled with low activation due to staff shortages at the various participating centres as a result of the COVID pandemic. The Steering Committee had to take the decision to close the accrual in the STEREO trial as of 31 October 2023.
    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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