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15-19 ABC-lung

Details

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 was exploring 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 Information

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
First Patient In:
29 September 2020
Accrual Closure Day:
27 September 2022

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 IBCSG Partners Foundation
Coordinating Group:
ETOP IBCSG Partners Foundation
Participating Group:
Spanish Lung Cancer Group (SLCG)
Participating Countries:
Europe: Germany, Spain, Switzerland
Asia: Singapore, South Korea
Registrations:
EudraCT number: 2019-001687-30
clinicaltrials.gov: NCT04245085

Contact

ETOP IBCSG Partners Foundation
Effingerstrasse 33
3008 Bern, Switzerland
ABC-lung@etop.ibcsg.org