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

Sponsor
ETOP IBCSG Partners Foundation
Study ID
NCT04245085
Phase
PHASE2
Status
Completed

Conditions

  • EGFRmutant Stage IIIB/C or IV Non-squamous NSCLC

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Sep 29, 2020
Status verified
Apr 2026
Primary completion
Jul 22, 2024
Completion
Jul 22, 2024

Study Design

Enrollment
95 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A
    * 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
  • Active Comparator: Arm B
    * Atezolizumab (1200 mg), Q3W, until PD * Bevacizumab (15 mg/kg), Q3W, until PD * Pemetrexed (500 mg/m2), Q3W, until PD

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. ]

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