Study of Veliparib in Combination With Nivolumab and Platinum Doublet Chemotherapy in Participants With Metastatic or Advanced Non-Small Cell Lung Cancer (NSCLC)

AbbVie

Status and phase: Completed; Phase 1

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: veliparib; Drug: pemetrexed; Drug: carboplatin; Drug: nivolumab; Drug: paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02944396

2016-001658-16 (EudraCT Number)

M15-534

Details and patient eligibility

About

This study seeks to establish the recommended Phase 2 dose (RPTD) of veliparib in combination with nivolumab and platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed) (Phase 1 portion) and to assess whether the addition of nivolumab to veliparib in combination with platinum doublet chemotherapy results will improve progression free survival (PFS) compared to veliparib with platinum doublet chemotherapy alone in participants with metastatic or advanced Non-small Cell Lung Cancer (NSCLC) (Phase 2 portion).

A strategy decision was made not to proceed to Phase 2 portion of this study due to change in standard of care.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant must have a life expectancy greater than 12 weeks,
• Participant must have cytologically or histologically confirmed Non-small Cell Lung Cancer (NSCLC).
• Participant must have metastatic or advanced NSCLC (Stage IIIB or IV) that is not amenable to surgical resection or radiation or chemoradiation with curative intent at time of study screening.
• Participant 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).
• Participant must have resolution to Grade 1 or lower of any toxic effects (excepting alopecia) of the most recent therapy prior to Cycle 1 Day 2.
• Participant must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 to 1.
• Participant must have adequate bone marrow, renal, and hepatic function.

Exclusion criteria

• Participant has received prior cytotoxic chemotherapy (including chemotherapy in combination with radiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy accompanied by surgery with curative intent that was completed one year prior to Cycle 1 Day -2.
• Participant has received prior therapy with a Poly-(ADP-ribose)-Polymerase (PARP) inhibitor.
• Participant has received prior treatment with any anti-programmed cell death protein-1 (anti-PD-1), or PD Ligand-1 (PD-L1) or PD Ligand-2 (PD-L2) agent or an antibody targeting other immunoregulatory receptors or mechanisms.
• Participant has received radiation therapy to lung greater than 30 Gy within 6 months, or antineoplastic biologic therapy within 21 days, or major surgery within 21 days, or tyrosine kinase inhibitor therapy within 7 days, or palliative radiation within 7 days of the first dose of study medication.
• Participant has untreated central nervous system (CNS) metastases.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Veliparib and nivolumab with platinum doublet chemotherapy

Experimental group

Description:

Veliparib and nivolumab in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed)

Treatment:

Drug: paclitaxel

Drug: nivolumab

Drug: carboplatin

Drug: pemetrexed

Drug: veliparib

Veliparib with platinum doublet chemotherapy

Experimental group

Description:

Veliparib in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed)

Treatment:

Drug: paclitaxel

Drug: carboplatin

Drug: pemetrexed

Drug: veliparib