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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
Group Labels: 2

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

Name: Pemetrexed

Description: Intravenous infusion
Type: Drug
Group Labels: 1

Investigator's choice of platinum doublet

Name: Carboplatin

Description: Intravenous infusion
Type: Drug
Group Labels: 2

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

Name: Cisplatin

Description: Intravenous infection
Type: Drug
Group Labels: 1

Investigator's choice of platinum doublet

Name: Veliparib

Description: Oral Capsule
Type: Drug
Group Labels: 1

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: