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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
| 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 |
Trial Organisation |
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| 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 |
| Coordinating Group: | ETOP IBCSG Partners |
| 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
Uli Kodjadjiku (Clinical Trial Manager)
ETOP IBCSG Partners Foundation
Effingerstrasse 33
3008 Bern, Switzerland
