A Study Evaluating Platinum-Pemetrexed-Atezolizumab (+/-Bevacizumab) for Patients With Stage IIIB/IV Non-squamous Non-small Cell Lung Cancer With EGFR Mutations, ALK Rearrangement or ROS1 Fusion Progressing After Targeted Therapies

Sponsor
Centre Francois Baclesse
Study ID
NCT04042558
Phase
PHASE2
Status
Completed

Conditions

  • ALK Gene Rearrangement Positive
  • EGFR Gene Mutation
  • NSCLC Stage IIIB
  • NSCLC Stage IV
  • ROS1 Gene Mutation

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The objective of this study is to assess the efficacy of the combination of Platinum (carboplatin or cisplatin), Pemetrexed, Atezolizumab+/- Bevacizumab if eligible, in stage IIIB/IV non-squamous non-small cell lung cancer patients with progression-enhancing mutations following targeted therapies.

Key Dates

Start date
Sep 26, 2019
Status verified
May 2026
Primary completion
Oct 22, 2021
Completion
Apr 9, 2025

Study Design

Enrollment
150 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort with Bevacizumab
    4 cycles of induction every 3 weeks with : * Carboplatin area under curve 6 mg/mL per minute per IV route or Cisplatin 75 mg/m² per IV route * Pemetrexed 500 mg/m² per IV route * Atezolizumab 1200 mg per IV route * Bevacizumab 15 mg/kg per IV route For patients without disease progression, treatment will be followed by maintenance therapy by Atezolizumab + Pemetrexed and Bevacizumab administered at the same dosage on 3-week cycles
  • Experimental: Cohort without Bevacizumab
    4 cycles of induction every 3 weeks with : * Carboplatin area under curve 6 mg/mL per minute per IV route or Cisplatin 75 mg/m² per IV route * Pemetrexed 500 mg/m² per IV route * Atezolizumab 1200 mg per IV route For patients without disease progression, treatment will be followed by maintenance therapy by Atezolizumab + Pemetrexed administered at the same dosage on 3-week cycles

Primary Outcome Measure

Objective Response Rate (ORR) According to RECIST 1.1 [ Time Frame: After the end of 4 cycles (15 weeks) ]

Related coverage on Hipa.ai

Related Studies