Abstract 1411TiP
Background
For patients (pts) with NSCLC stage IIIB/IV, immuno-checkpoint inhibitors (ICI) have emerged as a standard in first-line setting of pts without oncogenic addiction. Several data suggest a lower efficacy of immunotherapy as single treatment in pts with oncogenic addiction (especially EGFR mutation or ALK/ROS1 rearrangement). Assuming the addition of chemotherapy to immunotherapy may improve the management of patients with oncogenic addiction, we implemented a trial aiming to assess the efficacy of this combination in these subgroups of pts.
Trial design
This is a French open, multicenter, non-randomized phase II Study with two parallel cohorts: Cohort A (Platinum-Pemetrexed-Atezolizumab-Bevacizumab) and Cohort B (Platinum-Pemetrexed-Atezolizumab). To be included, pts must have an EGFR mutation or an ALK / ROS1 rearrangement, have progressed under one or more targeted therapies and be naïve of systemic chemotherapy for metastatic disease or no prior chemotherapy treatment for Stage IV non-squamous NSCLC except if <3 cycles, with treatment free-interval ≥ 1 year from inclusion since last chemotherapy. Pts on cohort A must also meet the eligibility criteria for Bevacizumab. The primary endpoint is objective response rate (ORR) after 4 treatment cycles, defined as the proportion of pts with radiologically confirmed complete or partial response according to RECIST v1.1 criteria assessed by masked, independent central review. The secondary endpoints are progression-free survival, duration of response, time to deterioration in lung symptoms, ORR according to immune RECIST criteria, overall survival, and tolerance profile. Blood banking is realised for further exploration of mutations in circulating DNA notably. We plan to enrol a total of 149 pts (75 for Cohort A and 74 for Cohort B) over 24 months. Since September 2019, 16 and 9 pts have been respectively included in cohort A and B.
Clinical trial identification
NCT04042558, registered on 2019, August, 1st.
Editorial acknowledgement
Legal entity responsible for the study
Comprehensive Cancer Centre François Baclesse, Caen, FRANCE.
Funding
Roche S.A.S.
Disclosure
All authors have declared no conflicts of interest.