Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Adults Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers

AbbVie

Status and phase: Completed; Phase 3

Conditions: Non-squamous Non-small Cell Lung Cancer

Treatments: Drug: Pemetrexed; Drug: Paclitaxel; Drug: Cisplatin; Drug: Carboplatin; Drug: Veliparib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02264990

M14-359

2014-002565-30 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of veliparib plus carboplatin and paclitaxel versus the Investigator's choice of standard chemotherapy in adults with metastatic or advanced non-squamous non-small cell lung cancer.

Enrollment: 595 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject must be ≥ 18 years of age with life expectancy > 12 weeks.
• Subject must have cytologically or histologically confirmed advanced or metastatic non-squamous NSCLC and are current or former smokers.
• Subject must have NSCLC that is not amenable to surgical resection or radiation with curative intent at time of screening.
• Subject must have at least 1 unidimensional measurable NSCLC lesion on a computed tomography (CT) scan as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Exclusion criteria

• Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor).
• Subject has a known hypersensitivity to platinum compounds.
• Subject has peripheral neuropathy ≥ grade 2.
• Subject has squamous NSCLC, or an untreated 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.
• Subject has received prior cytotoxic chemotherapy or chemoradiotherapy for NSCLC.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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595 participants in 2 patient groups

Veliparib + Carboplatin + Paclitaxel

Experimental group

Description:

Participants received 120 mg veliparib twice a day (BID) on Days -2 to 5 (7 days), carboplatin at an area under the curve (AUC) of 6 mg/mL\*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles. After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.

Treatment:

Drug: Veliparib

Drug: Paclitaxel

Drug: Carboplatin

Drug: Pemetrexed

Investigator's Choice Chemotherapy

Active Comparator group

Description:

Participants received Investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles: * Carboplatin AUC 6 mg/mL\*min + paclitaxel 200 mg/m² * Cisplatin 75 mg/m² + pemetrexed 500 mg/m² * Carboplatin AUC 6 or AUC 5 mg/mL\*min + pemetrexed 500 mg/m² After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.

Treatment:

Drug: Cisplatin

Drug: Paclitaxel

Drug: Carboplatin

Drug: Pemetrexed