NCT04245085

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: ETOP IBCSG Partners Foundation · Network
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Atezolizumab	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.
DRUG	Bevacizumab	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.
DRUG	Carboplatin	Patients in treatment Arm A will receive carboplatin, AUC5 every 3 weeks for 4-6 cycles.
DRUG	Paclitaxel	Patients in treatment Arm A will receive paclitaxel, 175-200 mg/m2 (at the investigators' discretion), every 3 weeks for 4-6 cycles.
DRUG	Pemetrexed	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.

Timeline

• Start date: 2020-09-29
• Primary completion: 2024-07-22
• Completion: 2024-07-22
• First posted: 2020-01-28
• Last updated: 2025-01-08

Locations

18 sites across 5 countries: Germany, Singapore, South Korea, Spain, Switzerland