ABC-lung: Atezolizumab, Bevacizumab and Chemotherapy in EGFR-mutant Non-small Cell Lung Carcinoma

NCT04245085 | Completed Phase 2 Results DMC

• 2 other identifiers: ETOP 15-19MO40586
• Study Type: interventional
• Target: 95
• Locations: 5 countries
• Sites: 18

Brief 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 cancer (NSCLC) harbouring EGFR mutations after failure of standard EGFR tyrosine kinase inhibitors (TKIs).

Conditions

EGFRmutant Stage IIIB/C or IV Non-squamous NSCLC

Keywords

NSLC; EGFRm

Outcome Measures

Primary Outcomes (1)

• 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.

  From randomization to 12 months; participants assessed for progression-free survival status at 12 months.

Secondary Outcomes (10)

• Progression-Free Survival

  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 were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.

• Overall Survival

  From randomization until death from any cause, up to 3 years.

• Objective Response

  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

  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.

Study Arms (2)

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

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

Drug: Atezolizumab; Drug: Bevacizumab; Drug: Pemetrexed

Interventions

Pemetrexed DRUG

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.

Also known as: Alimta

Arm B

Paclitaxel DRUG

Patients in treatment Arm A will receive paclitaxel, 175-200 mg/m2 (at the investigators' discretion), every 3 weeks for 4-6 cycles.

Arm A

Atezolizumab DRUG

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.

Also known as: Tecentriq

Arm A; Arm B

Bevacizumab DRUG

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.

Also known as: Avastin

Arm A; Arm B

Carboplatin DRUG

Patients in treatment Arm A will receive carboplatin, AUC5 every 3 weeks for 4-6 cycles.

Arm A

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• 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

You may not qualify if:

• 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
• 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.
• 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.

Sponsors & Collaborators

• Roche Pharma AG: collaborator
• ETOP IBCSG Partners Foundation: lead

Study Sites (18)

LungenClinic Grosshansdorf

Großhansdorf, Germany

Location

Asklepios Fachkliniken München-Gauting

München, Germany

Location

National University Hospital

Singapore, Singapore

Location

National Cancer Center

Goyang, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Location

Hospital Teresa Herrera

A Coruña, Spain

Location

ICO - Hospital Universitari Germans Trias i Pujol

Badalona, Spain

Location

Hospital De La Santa Creu I Sant Pau

Barcelona, Spain

Location

Vall d'Hebron University Hospital

Barcelona, Spain

Location

OSI Bilbao Basurto

Bilbao, Spain

Location

Complejo Hospitalario de Jaén

Jaén, Spain

Location

Hospital Universitario Insular Gran Canaria

Las Palmas de Gran Canaria, Spain

Location

Hospital Puerta de Hierro

Madrid, Spain

Location

Hospital Universitario Fundacion Jimenez Díaz

Madrid, Spain

Location

Hospital General de Valencia

Valencia, Spain

Location

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Location

UniversitätsSpital Zürich

Zurich, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 40023017 DERIVED

MeSH Terms

Interventions

atezolizumab; Bevacizumab; Carboplatin; Paclitaxel; Pemetrexed

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic

Results Point of Contact

• Title: Dr. Heidi Roschitzki-Voser, PhD
• Organization: ETOP IBCSG Partners Foundation

heidi.roschitzki@etop.ibcsg.org

+41 31 511 94 00

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: January 28, 2020
• Study Start: September 29, 2020
• Primary Completion: July 22, 2024
• Study Completion: July 22, 2024
• Last Updated: May 12, 2026
• Results First Posted: May 12, 2026

Record last verified: 2026-04

Locations

CH (3); DE (2); SG (1); KR (2); ES (10)