EGFRmutant Stage IIIB/C or IV Non-squamous NSCLCPhase 2ABC-lungNCT04245085
ABC-lung: Atezolizumab, Bevacizumab and Chemotherapy in EGFR-mutant Non-small Cell Lung Carcinoma
A Phase 2 study testing Atezolizumab, Bevacizumab and Carboplatin in people with EGFRmutant Stage IIIB/C or IV Non-squamous NSCLC, run by ETOP IBCSG Partners Foundation at 18 sites in 5 countries.
Trial summary
ETOP 15-19 ABC-lung is an international, multi-centre open-label, randomized phase II trial with two non-comparative parallel arms of atezolizumab plus bevacizumab with carboplatin-paclitaxel (Arm A) or atezolizumab, bevacizumab and pemetrexed (Arm B) in patients with stage IIIB-IV non-squamous non-small cell lung… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- EGFRmutant Stage IIIB/C or IV Non-squamous NSCLC
- What is being tested?
- Atezolizumab, Bevacizumab and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 18 sitesin 5 countries
- Study dates
- 29 Sep 2020to 22 Jul 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients (male/female) must be ≥18 years of age.
- Chemotherapy naïve, non-squamous NSCLC, stage IIIB/C (not amenable to radical therapy) or IV. Patients who have received previous adjuvant or neoadjuvant chemotherapy are eligible if the date of last dose of treatment was at least 12 months before randomisation.
- Known EGFR mutations genotypes by tissue or ctDNA, patients with common mutations (L858R or Del19) and other rare mutations (e.g. S768I, G719X) are eligible.
- Measurable or evaluable disease by RECIST v1.1.
- Disease progression (during or after) or unacceptable side effects from prior treatment with at least one EGFR TKI (washout period = 7 days).
- If most recent line of treatment (1st or 2nd line) was a third-generation EGFR TKI (e.g. osimertinib):
Show all 26Show fewer
- Patient must be known to be EGFR mutation positive, either on fresh tumour biopsy taken >7 days prior to protocol treatment start or by recent ctDNA analysis (informative ctDNA test, local test).
- T790M genotype is allowed
- If most recent line of treatment (1st or 2nd line) was a first- or second-generation EGFR TKI (e.g. afatinib, dacomitinib, erlotinib, gefitinib):
- Patient must be known to be tissue EGFR T790M wild type (local test) on most recent line of EGFR TKI or if no tissue re-biopsy, no evidence of T790M on ctDNA but identified L858R, del19, S768I or G719X genotypes (informative ctDNA test, local test)
- Treatment with an EGFR TKI therapy for at least 30 days
- Adequate haematological function:
- Haemoglobin greater or equal 90 g/L
- Absolute neutrophils count (ANC) greater or equal 1.5× 109/L
- Platelet count greater or equal 100× 109/L
- Adequate renal function:
- Creatinine clearance greater or equal 45 mL/min (using the Cockcroft-Gault formula)
- Adequate liver function:
- ALT and AST less or equal 2.5× ULN. If the patient has liver metastases, ALT and AST must be less or equal 5× ULN
- Total bilirubin less or equal 1.5x ULN.
- Willingness to provide any surplus tumour sample obtained at the time of acquired resistance to prior EGFR TKI
- Men and women of childbearing potential must agree to use adequate contraception
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Life expectancy greater or equal 12 weeks
- Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 7 days before randomisation.
- Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits and examinations including follow up.
Who cannot join
- Prior systemic cytotoxic chemotherapy for advanced stage NSCLC Patients who had received previous adjuvant or neoadjuvant chemotherapy are eligible if the last dose of treatment was at least 12 months before randomisation.
- Prior therapy with bevacizumab or other anti-angiogenic agent
- Prior immune checkpoint inhibitor therapy
- More than two lines of EGFR TKI therapy
- Known small-cell lung carcinoma (SCLC) or high grade neuroendocrine carcinoma (if progression biopsy has been performed locally).
- Squamous cell histologic subtype
Show all 45Show fewer
- Known EGFR T790M positive genotype by tissue on most recent EGFR TKI progression or ctDNA and have not received an approved EGFR TKI targeting T790M (e.g. a third-generation EGFR TKI such as osimertinib).
- Active or untreated CNS metastases as determined by brain MRI
- Patients with CNS metastases must be non-progressive by RECIST v1.1 and symptomatically stable with no ongoing requirement for corticosteroids as therapy for CNS disease; anticonvulsants at a stable dose allowed
- Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of randomization.
- Presence or history of a malignant disease that has been diagnosed and/or required therapy within the past 3 years. Exceptions to this exclusion include the following: completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type.
- Clear tumour infiltration into the thoracic great vessels (seen on imaging)
- QTc of grade ≥3 according to CTCAE v5.0
- Active autoimmune disease that has required systemic treatment in past 2 years. Patients with vitiligo, controlled type I diabetes mellitus on stable insulin, or residual autoimmune-related hypothyroidism only requiring hormone replacement or psoriasis not requiring systemic treatment are permitted
- Active or uncontrolled HIV, tuberculosis, hepatitis B or C infection
- Live attenuated vaccination within 4 weeks prior to randomisation.
- Subject receiving any biologic drugs targeting the immune system (for example, TNF blockers, anakinra, rituximab, abatacept, or tocilizumab) within 6 weeks prior to treatment start.
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
- Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg)
- Anti-hypertensive therapy to achieve these parameters is allowable.
- Prior history of hypertensive crisis or hypertensive encephalopathy
- Significant vascular disease (e.g. aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to randomization
- History of haemoptysis (greater or equal 2.5mL of bright red blood per episode) within 1 month prior to randomization
- Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
- Current or recent (within 10 days before randomization) use of aspirin (>325 mg/day) or treatment with dipyramidole, ticlopidine, clopidogrel, and clostazol
- Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes that has not been stable for >2 weeks prior to randomization
- The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to the medical standard of the enrolling institution) and the patient has been on a stable dose of anticoagulants for at least 2 weeks prior to randomization.
- Prophylactic anticoagulation for the patency of venous access devices is allowed, provided the activity of the agent results in an INR <1.5× ULN and aPTT is within normal limits within 14 days prior to randomization.
- Prophylactic use of low-molecular-weight heparin (i.e., enoxaparin 40 mg/day) is permitted.
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to the first dose of bevacizumab
- Major surgery or significant traumatic injury 28 days prior to the first dose of bevacizumab.
- Minor surgical procedure within 7 days, or placement of a vascular access device 2 days prior to the first dose of bevacizumab.
- History of abdominal or tracheoesophageal fistula or gastrointestinal perforation within 6 months prior to randomization
- Clinical signs of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding
- Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
- Serious, non-healing wound, active ulcer, or untreated bone fracture
- Proteinuria, as demonstrated by urine dipstick or >1.0 g of protein in a 24-hour urine collection
- All patients with greater or equal 2+ protein on dipstick urine analysis at baseline must undergo a 24 hour urine collection and must demonstrate lesser or equal 1 g of protein in 24 hours.
- Any unresolved toxicities from prior therapy greater than CTCAE v5.0 grade 1 at the time of starting trial treatment with the exception of alopecia
- History of hypersensitivity to the known active substances (atezolizumab, bevacizumab and chemotherapy drugs) or to any of the excipients.
- History of hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies.
- Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
- Women who are pregnant or in the period of lactation.
- Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the trial and up to 6 months after discontinuing trial treatment
- History of active diverticulitis
Trial locations and contacts
18 sites in 5 countries.
18 sites in 5 countries
Spain10 sites
Hospital Teresa Herrera
A Coruña
ICO - Hospital Universitari Germans Trias i Pujol
Badalona
Hospital De La Santa Creu I Sant Pau
Barcelona
Vall d'Hebron University Hospital
Barcelona
OSI Bilbao Basurto
Bilbao
Complejo Hospitalario de Jaén
Jaén
Hospital Universitario Insular Gran Canaria
Las Palmas de Gran Canaria
Hospital Puerta de Hierro
Madrid
Hospital Universitario Fundacion Jimenez Díaz
Madrid
Hospital General de Valencia
Valencia
Switzerland3 sites
Hôpitaux Universitaires de Genève
Geneva
Kantonsspital St. Gallen
Sankt Gallen
UniversitätsSpital Zürich
Zurich
Germany2 sites
LungenClinic Grosshansdorf
Großhansdorf
Asklepios Fachkliniken München-Gauting
München
South Korea2 sites
National Cancer Center
Goyang
Severance Hospital, Yonsei University Health System
Seoul
About this study
Official title: A Randomised Non-comparative Open Label Phase II Trial of Atezolizumab Plus Bevacizumab, With Carboplatin-paclitaxel or Pemetrexed, in EGFR-mutant Non-small Cell Lung Carcinoma With Acquired Resistance
ETOP 15-19 ABC-lung is an international, multi-centre open-label, randomized phase II trial with two non-comparative parallel arms of atezolizumab plus bevacizumab with carboplatin-paclitaxel (Arm A) or atezolizumab, bevacizumab and pemetrexed (Arm B) in patients with stage IIIB-IV non-squamous non-small cell lung cancer (NSCLC) harbouring EGFR mutations after failure of standard EGFR tyrosine kinase inhibitors (TKIs).
- Being tested
- Atezolizumab, Bevacizumab, Carboplatin, Paclitaxel, Pemetrexed
- Keywords
- NSLC, EGFRm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabDrug
Also called Tecentriq
Patients in both treatment arms will receive atezolizumab at a fixed dose of 1200 mg i.v. on day one of every 3-week (3 days) cycle, until progression of disease determined according to RECIST v1.1 or lack of tolerability, or patient declines further treatment.
Treatment beyond RECIST-defined progression will be allowed if patient is continuing to derive clinical benefit.
BevacizumabDrug
Also called Avastin
Patients in both treatment arms will receive bevacizumab at a dose of 15 mg/kg i.v. on day one of every 3-week (+/- 3 days) cycle, until progression of disease determined according to RECIST v1.1 or lack of tolerability, or patient declines further treatment.
CarboplatinDrug
Patients in treatment Arm A will receive carboplatin, AUC5 every 3 weeks for 4-6 cycles.
PaclitaxelDrug
Patients in treatment Arm A will receive paclitaxel, 175-200 mg/m2 (at the investigators' discretion), every 3 weeks for 4-6 cycles.
PemetrexedDrug
Also called Alimta
Patients in treatment Arm B will receive Pemetrexed, 500 mg/m2 every 3 weeks until progression of disease determined according to RECIST v1.1 or lack of tolerability, or patient declines further treatment.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | * Atezolizumab (1200 mg) Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Carboplatin (AUC5) Q3W, 4-6 cycles
* Paclitaxel (175-200 mg/m2), Q3W, 4-6 cycles Receives: Drug: Atezolizumab; Drug: Bevacizumab; Drug: Carboplatin; Drug: Paclitaxel |
| Arm B | Active comparator | * Atezolizumab (1200 mg), Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Pemetrexed (500 mg/m2), Q3W, until PD Receives: Drug: Atezolizumab; Drug: Bevacizumab; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) Rate at 12-months
Progression-Free Survival (PFS) rate at 12-months is defined as the rate of patients without a PFS event at 12 months from randomisation. PFS is defined as the time from the date of randomisation until documented progression (according to RECIST v1.1) or death, if progression is not documented. Censoring (for patients without a PFS/death event) will occur at the last tumour assessment if the patient is lost to follow-up or refuses further documentation of follow-up.
Measured: From randomization to 12 months; participants assessed for progression-free survival status at 12 months.
Secondary outcomes (10)
Progression-Free Survival
PFS is defined as the time from the date of randomisation until documented progression (according to RECIST v1.1) or death, if progression is not documented. Censoring (for patients without a PFS/death event) will occur at the last tumour assessment if the patient is lost to follow-up or refuses further documentation of follow-up.
Measured: From randomization until documented progression (PD) according to RECIST v1.1 or death from any cause (whichever occurred first), up to 3 years.
Adverse Events
Adverse events, graded by CTCAE version 5.0.
Measured: Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
Overall Survival
OS is defined as the time from the date of randomisation until death from any cause. Censoring will occur at the last follow-up date.
Measured: From randomization until death from any cause, up to 3 years.
Objective Response
Objective response is defined as best overall response (CR or PR) across all assessment time-points according to RECIST v1.1, from randomisation until either the end of protocol treatment or the end of follow-up.
Measured: From randomisation to termination of trial treatment, up to 3 years.
Time to Deterioration (TTDet) in the QLQ-C30 Global Health Status/Global QoL Scale
TTDet is defined as the time from baseline to the first time that the patient's score shows a ≥10-point decrease above baseline in the EORTC-QLQ-C30 global health/ QoL scale. Patients with no definitive deterioration events will be censored at the date of the last available QoL assessment.
Deterioration must be held for at least two consecutive assessments or be followed by PD and/or death within the next 3 weeks.
Measured: From randomization until patient deterioration status (score for QLQ-C30 global health status/QoL scale shows a ≥10-point decrease from baseline), up to 3 years.
Time to Deterioration (TTDet) in the QLQ-LC13 'Cough' Symptom
TTDet is defined as the time from baseline to the first time that the patient's score shows a ≥10-point increase above baseline in the QLQ-LC13 'Cough' symptom. Patients with no definitive deterioration events will be censored at the date of the last available QoL assessment.
Deterioration must be held for at least two consecutive assessments or be followed by PD and/or death within the next 3 weeks.
Measured: From randomization until patient deterioration status (score for QLQ-LC13 'Cough' symptom shows a ≥10-point increase from baseline), up to 3 years.
Time to Deterioration (TTDet) in the QLQ-LC13 'Dyspnoea' Symptom
TTDet is defined as the time from baseline to the first time that the patient's score shows a ≥10-point increase above baseline in the QLQ-LC13 'Dyspnoea' symptom. Patients with no definitive deterioration events will be censored at the date of the last available QoL assessment.
Deterioration must be held for at least two consecutive assessments or be followed by PD and/or death within the next 3 weeks.
Measured: From randomization until patient deterioration status (score for QLQ-LC13 'Dyspnoea' symptom shows a ≥10-point increase from baseline), up to 3 years.
Time to Deterioration (TTDet) in the QLQ-LC13 'Chest Pain' Symptom
TTDet is defined as the time from baseline to the first time that the patient's score shows a ≥10-point increase above baseline in the QLQ-LC13 'Chest pain' symptom. Patients with no definitive deterioration events will be censored at the date of the last available QoL assessment.
Deterioration must be held for at least two consecutive assessments or be followed by PD and/or death within the next 3 weeks.
Measured: From randomization until patient deterioration status (score for QLQ-LC13 'Chest pain' symptom shows a ≥10-point increase from baseline), up to 3 years.
Extra-cranial PFS
Extra-cranial progression-free-survival is the time from randomisation to documentation of disease progression outside the central nervous system (CNS) as per RECIST v1.1 or death, whichever occurred first.
Measured: From randomization until documented progression (PD) outside the central nervous system (CNS) according to RECIST v1.1 or death from any cause (whichever occurred first), up to 3 years.
Intracranial PFS
Intracranial progression-free-survival is defined as the time from randomisation to first documented radiographic evidence of CNS progression or death, whichever occurred first. CNS progression is defined as progression due to newly developed CNS lesions and/or progression of pre-existing baseline CNS lesions.
Measured: From randomization until first documented radiographic evidence of CNS progression according to RECIST v1.1 or death from any cause (whichever occurred first), up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start29 Sep 2020
- Primary completion22 Jul 2024
- Study completion22 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EGFRmutant Stage IIIB/C or IV Non-squamous NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- ETOP IBCSG Partners Foundation
- Sponsor type
- Research network
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245085
- Sponsor's protocol ID
- ETOP 15-19
- Other IDs
- MO40586
- Acronym
- ABC-lung
- Status last verified
- Apr 2026
- First submitted
- 16 Dec 2019
- Last updated
- 29 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Soo RA, Vervita K, Fruh M, Cho BC, Majem M, Rodriguez Abreu D, Ribi K, Callejo A, Moran T, Domine Gomez M, Provencio M, Addeo A, Han JY, Ortega Granados AL, Reck M, Blasco A, Garcia Campelo R, Sala Gonzalez MA, Britschgi C, Roschitzki-Voser H, Ruepp B, Gasca-Ruchti A, Haberecker M, Dafni U, Peters S, Stahel RA; ETOP 15-19 ABC-lung collaborators. A randomised non-comparative phase II study of atezolizumab, bevacizumab and chemotherapy in EGFR-mutant NSCLC with acquired resistance - The ETOP 15-19 ABC-lung trial. Lung Cancer. 2025 Apr;202:108454. doi: 10.1016/j.lungcan.2025.108454. Epub 2025 Feb 20.
PubMed 40023017
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Non-comparative Open Label Phase II Trial of Atezolizumab Plus Bevacizumab, With Carboplatin-paclitaxel or Pemetrexed, in EGFR-mutant Non-small Cell Lung Carcinoma With Acquired Resistance
- ClinicalTrials.gov ID
- NCT04245085
- Acronym / sponsor ID
- ABC-lung / ETOP 15-19
- Keywords
- NSLC, EGFRm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- ETOP IBCSG Partners FoundationResearch network
- Collaborators
- Roche Pharma AG
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 22 Jul 2024 (actual)
- Study completion
- 22 Jul 2024 (actual)
- First posted
- 28 Jan 2020 (actual)
- Results
- Posted 12 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ETOP 15-19 ABC-lung is an international, multi-centre open-label, randomized phase II trial with two non-comparative parallel arms of atezolizumab plus bevacizumab with carboplatin-paclitaxel (Arm A) or atezolizumab, bevacizumab and pemetrexed (Arm B) in patients with stage IIIB-IV non-squamous non-small cell lung cancer (NSCLC) harbouring EGFR mutations after failure of standard EGFR tyrosine kinase inhibitors (TKIs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: Atezolizumab, Drug: Bevacizumab, Drug: Carboplatin, Drug: Paclitaxel* Atezolizumab (1200 mg) Q3W, until PD * Bevacizumab (15 mg/kg), Q3W, until PD * Carboplatin (AUC5) Q3W, 4-6 cycles * Paclitaxel (175-200 mg/m2), Q3W, 4-6 cycles |
| Arm B | Active comparator | Drug: Atezolizumab, Drug: Bevacizumab, Drug: Pemetrexed* Atezolizumab (1200 mg), Q3W, until PD * Bevacizumab (15 mg/kg), Q3W, until PD * Pemetrexed (500 mg/m2), Q3W, until PD |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Patients (male/female) must be ≥18 years of age.
- Chemotherapy naïve, non-squamous NSCLC, stage IIIB/C (not amenable to radical therapy) or IV. Patients who have received previous adjuvant or neoadjuvant chemotherapy are eligible if the date of last dose of treatment was at least 12 months before randomisation.
- Known EGFR mutations genotypes by tissue or ctDNA, patients with common mutations (L858R or Del19) and other rare mutations (e.g. S768I, G719X) are eligible.
- Measurable or evaluable disease by RECIST v1.1.
- Disease progression (during or after) or unacceptable side effects from prior treatment with at least one EGFR TKI (washout period = 7 days).
Key exclusion criteria (45 listed)
- Prior systemic cytotoxic chemotherapy for advanced stage NSCLC Patients who had received previous adjuvant or neoadjuvant chemotherapy are eligible if the last dose of treatment was at least 12 months before randomisation.
- Prior therapy with bevacizumab or other anti-angiogenic agent
- Prior immune checkpoint inhibitor therapy
- More than two lines of EGFR TKI therapy
- Known small-cell lung carcinoma (SCLC) or high grade neuroendocrine carcinoma (if progression biopsy has been performed locally).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtezolizumabAlso: TecentriqPatients in both treatment arms will receive atezolizumab at a fixed dose of 1200 mg i.v. on day one of every 3-week (3 days) cycle, until progression of disease determined according to RECIST v1.1 or lack of tolerability, or patient declines further treatment. Treatment beyond RECIST-defined progression will be allowed if patient is continuing to derive clinical benefit. | Drug | Arm A, Arm B |
| BevacizumabAlso: AvastinPatients in both treatment arms will receive bevacizumab at a dose of 15 mg/kg i.v. on day one of every 3-week (+/- 3 days) cycle, until progression of disease determined according to RECIST v1.1 or lack of tolerability, or patient declines further treatment. | Drug | Arm A, Arm B |
| CarboplatinPatients in treatment Arm A will receive carboplatin, AUC5 every 3 weeks for 4-6 cycles. | Drug | Arm A |
| PaclitaxelPatients in treatment Arm A will receive paclitaxel, 175-200 mg/m2 (at the investigators' discretion), every 3 weeks for 4-6 cycles. | Drug | Arm A |
| PemetrexedAlso: AlimtaPatients in treatment Arm B will receive Pemetrexed, 500 mg/m2 every 3 weeks until progression of disease determined according to RECIST v1.1 or lack of tolerability, or patient declines further treatment. | Drug | Arm B |
Primary outcome
Progression-Free Survival (PFS) Rate at 12-months
Time frame: From randomization to 12 months; participants assessed for progression-free survival status at 12 months.
Progression-Free Survival (PFS) rate at 12-months is defined as the rate of patients without a PFS event at 12 months from randomisation. PFS is defined as the time from the date of randomisation until documented progression (according to RECIST v1.1) or death, if progression is not documented. Censoring (for patients without a PFS/death event) will occur at the last tumour assessment if the patient is lost to follow-up or refuses further documentation of follow-up.
10 secondary outcomes
Progression-Free Survival
Time frame: From randomization until documented progression (PD) according to RECIST v1.1 or death from any cause (whichever occurred first), up to 3 years.
Adverse Events
Time frame: Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
Overall Survival
Time frame: From randomization until death from any cause, up to 3 years.
Objective Response
Time frame: From randomisation to termination of trial treatment, up to 3 years.
Time to Deterioration (TTDet) in the QLQ-C30 Global Health Status/Global QoL Scale
Time frame: From randomization until patient deterioration status (score for QLQ-C30 global health status/QoL scale shows a ≥10-point decrease from baseline), up to 3 years.
Time to Deterioration (TTDet) in the QLQ-LC13 'Cough' Symptom
Time frame: From randomization until patient deterioration status (score for QLQ-LC13 'Cough' symptom shows a ≥10-point increase from baseline), up to 3 years.
Time to Deterioration (TTDet) in the QLQ-LC13 'Dyspnoea' Symptom
Time frame: From randomization until patient deterioration status (score for QLQ-LC13 'Dyspnoea' symptom shows a ≥10-point increase from baseline), up to 3 years.
Time to Deterioration (TTDet) in the QLQ-LC13 'Chest Pain' Symptom
Time frame: From randomization until patient deterioration status (score for QLQ-LC13 'Chest pain' symptom shows a ≥10-point increase from baseline), up to 3 years.
Extra-cranial PFS
Time frame: From randomization until documented progression (PD) outside the central nervous system (CNS) according to RECIST v1.1 or death from any cause (whichever occurred first), up to 3 years.
Intracranial PFS
Time frame: From randomization until first documented radiographic evidence of CNS progression according to RECIST v1.1 or death from any cause (whichever occurred first), up to 3 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40023017Soo RA, Vervita K, Fruh M, Cho BC, Majem M, Rodriguez Abreu D, Ribi K, Callejo A, Moran T, Domine Gomez M, Provencio M, Addeo A, Han JY, Ortega Granados AL, Reck M, Blasco A, Garcia Campelo R, Sala Gonzalez MA, Britschgi C, Roschitzki-Voser H, Ruepp B, Gasca-Ruchti A, Haberecker M, Dafni U, Peters S, Stahel RA; ETOP 15-19 ABC-lung collaborators. A randomised non-comparative phase II study of atezolizumab, bevacizumab and chemotherapy in EGFR-mutant NSCLC with acquired resistance - The ETOP 15-19 ABC-lung trial. Lung Cancer. 2025 Apr;202:108454. doi: 10.1016/j.lungcan.2025.108454. Epub 2025 Feb 20.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atezolizumab, Bevacizumab and Carboplatin in people with EGFRmutant Stage IIIB/C or IV Non-squamous NSCLC, run by ETOP IBCSG Partners Foundation at 18 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Spain, Switzerland, Germany, South Korea, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) Rate at 12-months (time frame: From randomization to 12 months; participants assessed for progression-free survival status at 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04245085, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.