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Report for Clinical Trial NCT03977194

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase III Randomized Trial of Atezolizumab in Elderly Patients With Advanced Non-Small-Cell Lung Cancer and Receiving Monthly Carboplatin With Weekly Paclitaxel Chemotherapy

Non Small Cell Lung Cancer (NSCLC) remains the leading cause of death by cancer in the world. Because of the increase in lung cancer incidence with age and the increase of life expectancy, about half of the patients are patients aged 70 or older. Several clinical trials have shown the interest of adding immunotherapy to standard 1st line chemotherapy in NSCLC. Although in these studies there was not necessarily a higher age limit, in fact the proportion of included patients aged 75 or older remains low (between 7 and 10%). It is therefore necessary to conduct a trial dedicated to these patients in order to determine whether immunotherapy is as effective and tolerated as in the general population.

NCT03977194 Non Small Cell Lung Cancer Metastatic
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

3 Interventions

Name: Carboplatin

Description: AUC 6 every 4 weeks
Type: Drug
Group Labels: 2

Arm A : standard treatment Arm B : standard treatment + immunotherapy

Name: Paclitaxel

Description: 90 mg/m² D1, 8, 15, every 4 weeks
Type: Drug
Group Labels: 2

Arm A : standard treatment Arm B : standard treatment + immunotherapy

Name: Atezolizumab

Description: 1200 mg every 3 weeks
Type: Drug
Group Labels: 1

Arm B : standard treatment + immunotherapy


Primary Outcomes

Description: Time from randomization until death due to any cause

Measure: Overall Survival

Time: 11 months after randomization of the last subject

Secondary Outcomes

Description: Time from randomization to first observation of progression (according to RECIST v1.1) or date of death (from any cause).

Measure: Progression-free survival

Time: 11 months after randomization of the last subject

Description: Best response according to RECIST v1.1 from start to end of study treatment

Measure: Best overall response rate

Time: 11 months after randomization of the last subject

Description: Time from documentation of tumor response to disease progression

Measure: Duration of response

Time: 11 months after randomization of the last subject

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 G719A

Exclusion Criteria: 1. Small cell lung cancer or tumors with mixt histology including a SCLC component 2. Known EGFR activating tumor mutation (deletion LREA in exon 19, L858R ou L861X mutations in exon 21, G719A/S mutation in exon 18) or HER2 exon 20 insertion (either tissue or plasma cfDNA mutation). --- L858R --- --- G719A ---


2 L858R

Exclusion Criteria: 1. Small cell lung cancer or tumors with mixt histology including a SCLC component 2. Known EGFR activating tumor mutation (deletion LREA in exon 19, L858R ou L861X mutations in exon 21, G719A/S mutation in exon 18) or HER2 exon 20 insertion (either tissue or plasma cfDNA mutation). --- L858R ---



HPO Nodes


HPO: