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Report for Clinical Trial NCT04042558

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Multicentre Phase II, Open-label, Non-randomized 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

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.

NCT04042558 NSCLC Stage IIIB NSCLC Stage IV EGFR Gene Mutation ALK Gene Rearrangement Positive ROS1 Gene Mutation
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

2 Interventions

Name: Carboplatin + Pemetrexed + Atezolizumab + Bevacizumab

Description: 4 cycles of induction every 3 weeks of cisplatine,pemetrexed, atezolizumab + bevacizumab and patients without disease progression, treatment will be followed by maintenance therapy by Atezolizumab + Pemetrexed +/- Bevacizumab administered at the same dosage on 3-week cycles
Type: Drug
Group Labels: 1

Cohort with Bevacizumab

Name: Carboplatin + Pemetrexed + Atezolizumab

Description: Carboplatin + Pemetrexed + Atezolizumab
Type: Drug
Group Labels: 1

Cohort without Bevacizumab


Primary Outcomes

Measure: Objective response rate (ORR) according to RECIST 1.1

Time: After the end of 4 cycles (15 weeks)

Secondary Outcomes

Measure: The progression-free survival (PFS)

Time: 1 year

Measure: The overall survival

Time: 1 year

Measure: The duration of response

Time: 1 year

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 T790M

After a first line of treatment with a TKI, most patients progress and are eligible according to the mechanism of progression to a TKI of 3rd generation in case of T790M resistance or chemotherapy. --- T790M ---



HPO Nodes


HPO: