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.

ABC-lung: Atezolizumab, Bevacizumab and Chemotherapy in EGFR mutant non-small cell lung carcinoma

The trials explores the efficacy in terms of progression-free survival of atezolizumab and bevacizumab in in combination with carboplatin and paclitaxel or with pemetrexed in patients with EGFR-mutant NSCLC after failure of standard EGFR-targeted therapies.

Trial Scheme

 

 trial scheme

 

Primary Endpoint: Progression-free survival rate at 12 months according to RECIST v1.1
Secondary Endpoints:

Objective response according to RECIST v1.1

Extra-cranial progression-free survival

Intracranial progression-free survival

Overall survival, including overall survival rate at 12 months

Adverse events according to CTCAE v5.0

Patient reported quality of life

Target Sample Size: 95 randomised patients
Protocol Release Date: 15 November 2019
Trial Activation Date:  23 April 2020
   

Trial Organisation

Trial Chair: Ross Soo, Singapore
Trial Co-Chairs:

Martin Früh, St. Gallen

Delvys Rodriguez Abreu, Gran Canaria

Margarita Majem Tarruella, Barcelona

Sponsor: ETOP
Coordinating Group: ETOP
Participating Group: SLCG
Participating Countries:

Europe: Germany, Spain, Switzerland and the United Kingdom

Asia: Singapore and South Korea

Registrations:

EudraCT number: 2019-001687-30

clinicaltrials.gov: NCT04245085


Contact

Robin Schweri (Trial Manager)

Tel: +41 31 511 94 45

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European Thoracic Oncology Platform

c/o IBCSG

Effingerstrasse 40

3008 Bern, Switzerland

Tel: +41 31 511 94 00