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Report for Clinical Trial NCT02264990

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Randomized, Open-Label, Multicenter, Phase 3 Trial Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Subjects Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers

This is a 2-arm, Phase 3 study to evaluate the safety and efficacy of veliparib plus carboplatin and paclitaxel versus the Investigator's choice of standard chemotherapy in Lung Subtype Panel (LSP) positive subjects with metastatic or advanced non-squamous non-small cell lung cancer.

NCT02264990 Non-squamous Non-small Cell Lung Cancer
MeSH: Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO: Neoplasm of the lung Non-small cell lung carcinoma

5 Interventions

Name: Paclitaxel

Description: Intravenous infusion

Type: Drug

Investigator's choice of platinum doublet Veliparib/Carboplatin/Paclitaxel

Name: Pemetrexed

Description: Intravenous infusion

Type: Drug

Investigator's choice of platinum doublet

Name: Carboplatin

Description: Intravenous infusion

Type: Drug

Investigator's choice of platinum doublet Veliparib/Carboplatin/Paclitaxel

Name: Cisplatin

Description: Intravenous infection

Type: Drug

Investigator's choice of platinum doublet

Name: Veliparib

Description: Oral Capsule

Type: Drug

Veliparib/Carboplatin/Paclitaxel


Primary Outcomes

Description: Overall survival is defined as the number of days from the date that the participant was randomized to the date of the participant's death.

Measure: Overall Survival (OS) in the LSP (Lung Subtype Panel) positive subgroup

Time: Up to 3 years from first dose of study drug.

Secondary Outcomes

Description: Objective response rate is defined as the proportion of participants with complete or partial response as determined by the investigator per Response Evaluation Criteria In Solid Tumors (version 1.1).

Measure: Objective Response Rate (ORR) in the LSP (Lung Subtype Panel) positive subgroup and all participants

Time: Up to 3 years from first dose of study drug

Description: Progression-free survival is defined as the number of days from participant randomization to the date the participant experiences an event of disease progression (PD) or death (all causes of mortality), if PD is not reached.

Measure: Progression Free Survival (PFS) in the LSP (Lung Subtype Panel) positive subgroup and all participants

Time: Up to 5 years from first dose of study drug

Description: Overall survival is defined as the number of days from the date that the participant was randomized to the date of the participant's death.

Measure: Overall Survival (OS) in all participants

Time: Up to 5 years from first dose of study drug.

Other Outcomes

Description: Participants will answer the European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L) and the Functional Assessment of Cancer Therapy (FACT) Lung Symptom Index-17 questionnaire.

Measure: Change in Quality of Life in the LSP (Lung Subtype Panel) positive subgroup and in all participants

Time: From Screening (prior to dosing) up to 2 years

Description: The duration of overall response for a participant is defined as the number of days from when the criteria is met for a complete or partial response (whichever occurs first), to the date that progressive disease (PD) is objectively documented.

Measure: Duration of overall response (DOR) in the LSP (Lung Subtype Panel) positive subgroup and in all participants

Time: Up to 3 years from randomization.

Measure: Change in Eastern Cooperative Oncology Group (ECOG) Performance Status in the LSP (Lung Subtype Panel) positive subgroup and in all participants

Time: From Screening (prior to dosing) up to 2 years

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 L858R

- Subject has peripheral neuropathy ≥ grade 2. - Subject has squamous NSCLC, or an untreated known EGFR mutation of exon 19 deletion or L858R mutation in exon 21, or a known ALK gene rearrangement. --- L858R ---



HPO Nodes


HPO:
Neoplasm of the lung
Genes 61
REST GPC3 WT1 HPGD BRAF PIK3CA TP53 TRIM28 RB1 TRIP13 SLCO2A1 AKT1 CASP8 KRAS TSC1 POU6F2 EWSR1 PRKN LMNA NAB2 TERT TSC2 SLC22A18 BRCA2 PPP2R1B STAT6 STK11 MUC5B ERBB2 TSC2 MBTPS2 BAP1 TSC2 DICER1 PDGFRB PERP EGFR TSC1 DIS3L2 NOTCH3 KEAP1 DICER1 DICER1 WT1 TSC1 C11ORF95 IRF1 CYP2A6 WRN RELA WT1 PTEN SFTPC SFTPA2 ERCC6 TRPV3 TP53 H19 TRIM28 FASLG MAP3K8
Non-small cell lung carcinoma
Genes 3
TP53 TP53 BAP1