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Report for Clinical Trial NCT02106546

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Randomized, Double-Blind, Multicenter, Phase 3 Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

This is a 2 arm Phase 3 study to evaluate the safety and efficacy of the addition of veliparib plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin and paclitaxel in subjects with advanced or metastatic squamous NSCLC.

NCT02106546 Squamous Non-Small Cell Lung Cancer
MeSH: Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO: Neoplasm of the lung Non-small cell lung carcinoma

4 Interventions

Name: carboplatin

Description: Intravenous infusion

Type: Drug

placebo and carboplatin and paclitaxel veliparib and carboplatin and paclitaxel

Name: veliparib

Description: Oral Capsule

Type: Drug

veliparib and carboplatin and paclitaxel

Name: paclitaxel

Description: Intravenous infusion

Type: Drug

placebo and carboplatin and paclitaxel veliparib and carboplatin and paclitaxel

Name: placebo

Description: Oral Capsule

Type: Drug

placebo and carboplatin and paclitaxel


Primary Outcomes

Description: Time to death for a given subject will be defined as the number of days from the date that the subject was randomized to the date of the subject's death.

Measure: Overall Survival (OS) in current smokers

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

Secondary Outcomes

Description: Time to death for a given subject will be defined as the number of days from the date that the subject was randomized to the date of the subject's death.

Measure: Overall Survival (OS) in all subjects

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

Description: Defined as the number of days from the date that the subject was randomized to the date the subject experiences an event of disease progression or to the date of death (all causes of mortality) if disease progression is not reached.

Measure: Progressive-Free Survival (PFS) in current smokers and in all subjects

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

Description: Objective response rate is defined as the proportion of subjects with complete or partial response as determined by the investigator per RECIST (version 1.1)

Measure: Objective Response Rate (ORR) in current smokers and in all subjects

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

Other Outcomes

Measure: Change in Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life Core 30 Question Questionnaire (EORTC-QLQ-C30).

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

Measure: Change in Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life Lung Cancer 13 Question Questionnaire (EORTC-LC13).

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

Measure: Change in Eastern Cooperative Oncology Group (ECOG) Performance Status

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

Measure: Change in Quality of Life: European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L)

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

Description: The duration of overall response for a given subject will be defined as the number of days from the day the criteria are met for Complete or Partial Response (whichever is recorded first) to the date that Progressive Disease (PD) is objectively documented.

Measure: Duration of Response

Time: From complete or partial response to disease progression (up to 3 years from randomization).

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 L858R

3. Subject has peripheral neuropathy >= grade 2. 4. Subject has non-squamous NSCLC, or a known Epidermal Growth Factor Receptor (EGFR) mutation of exon 19 deletion or L858R mutation in exon 21, or a known Anaplastic Lymphoma Kinase (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