SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03977194

Developed by Shray Alag, 2019.
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

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

Name: Paclitaxel

Description: 90 mg/m² D1, 8, 15, every 4 weeks

Type: Drug

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

Name: Atezolizumab

Description: 1200 mg every 3 weeks

Type: Drug

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:
Neoplasm of the lung
Genes 43
WT1 KRAS SLC22A18 STK11 IRF1 AKT1 C11ORF95 PRKN PPP2R1B ERBB2 TRPV3 TSC1 POU6F2 TSC2 EWSR1 RELA KEAP1 REST DIS3L2 SFTPA2 GPC3 MBTPS2 LMNA PTEN BRAF BRCA2 EGFR RB1 TRIP13 PDGFRB TERT SFTPC PIK3CA TRIM28 DICER1 MAP3K8 HPGD SLCO2A1 H19 TP53 NOTCH3 BAP1 WRN
Non-small cell lung carcinoma
Genes 2
TP53 BAP1