SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02106546

Developed by Shray Alag, 2019.
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

veliparib and carboplatin and paclitaxel placebo and carboplatin and paclitaxel

Name: veliparib

Description: Oral Capsule

Type: Drug

veliparib and carboplatin and paclitaxel

Name: paclitaxel

Description: Intravenous infusion

Type: Drug

veliparib and carboplatin and paclitaxel placebo 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 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