ETOP 15-19 ABC-lung; version 2.0, dated 12 January 2021
Research type
Research Study
Full title
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
IRAS ID
275908
Contact name
Anita Hiltbrunner
Contact email
Sponsor organisation
European Thoracic Oncology Platform (ETOP)
Eudract number
2019-001687-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 17 days
Research summary
Non-small cell lung cancer (NSCLC)represents up to 85% of all lung cancers and at time of diagnosis, about 70 % of patients have advanced disease not amenable to surgical resection. Mutations in a receptor called EGFR are identified in 10-40% of NSCLC patients. Tyrosine kinase inhibitors (TKIs) are the standard treatment in patients with advanced NSCLC and with EGFR mutations. However, acquired resistance often occur, resulting in failure with TKI targeted therapy.
Chemotherapy is the standard treatment when resistance with TKIs occurs. The effect of the treatment can be improved by combining chemotherapy with bevacizumab (an immune protein that prevents the development of blood vessels to the tumour) and with atezolizumab (a protein that enhances the activity of a type of immune cells).
The aim of this clinical trial is to explore the combination of atezolizumab and bevacizumab in patients with EGFR mutated NSCLC after failure of EGFR targeted therapies, by independently verifying outcomes in patients treated with carboplatin-pacitaxel (Arm A) and also explore outcomes with an investigational backbone of pemetrexed monotherapy (Arm B).
Chemotherapy naive NSCLC stage IIIB/C or IV patients older than 18 years with EGFR mutations after failure of EGFR TKI treatment, who have adequate haematological, renal and liver functions are eligible to take part. 95 patients from 25 centers are expected to be included in this trial.
Subjects will receive either atezolizumab, bevacizumab and 4-6 cycles of the chemotherapy combination carboplatin and paclitaxel (Arm A) or atezolizumab, bevacizumab and pemetrexed (Arm B) every 3 weeks until worsening of disease. The condition of the subjects will be assessed every three weeks with blood tests and quality of life questionnaires and every 6 and 12 weeks with radiological examinations (CT and MRI, respectively).
The research project is funded by European Thoracic Oncology Platform.
REC name
London - Central Research Ethics Committee
REC reference
21/LO/0491
Date of REC Opinion
6 Jul 2021
REC opinion
Favourable Opinion