NCT04701307

Niraparib and Dostarlimab for the Treatment of Small Cell Lung Cancer and Other High-Grade Neuroendocrine Carcinomas

Niraparib (PARP Inhibitor) Plus Dostarlimab (Anti-PD1) for Small Cell Lung Cancer (SCLC) and Other High-Grade Neuroendocrine Carcinomas (NEC)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the effect of niraparib and dostarlimab in treating small cell lung cancer and other high-grade neuroendocrine carcinomas. Niraparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Immunotherapy with monoclonal antibodies, such as dostarlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving niraparib and dostarlimab may help to control the diseases.

Detailed description

PRIMARY OBJECTIVE: I. To determine objective response rate (ORR) and 6-month progression free survival (PFS) in response to combined niraparib plus dostarlimab in patients with recurrent small cell lung cancer (SCLC) and high-grade neuroendocrine carcinomas (NECs). SECONDARY OBJECTIVES: I. To evaluate toxicity of combined niraparib plus dostarlimab (PARP inhibition plus anti-PD-1) in patients with recurrent SCLC and other high-grade NECs. II. To determine overall survival (OS), PFS, disease control rate (response plus stable disease \> 12 weeks) to combined niraparib plus dostarlimab in patients with recurrent SCLC and other high-grade NECs. EXPLORATORY OBJECTIVE: I. To determine treatment-related changes in immune profiles or other biomarker in response to combined niraparib plus dostarlimab in patients with recurrent SCLC and other high-grade NECs. OUTLINE: Patients receive niraparib orally (PO) once daily (QD) on days 1-21 of cycles 1-4, and on days 1-42 of subsequent cycles. Patients also receive dostarlimab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days for cycles 1-4 and every 42 days for subsequent cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up within 90 days, every 6 months for 2 years, then annually for 3 years.

Conditions

• Lung Small Cell Carcinoma
• Neuroendocrine Carcinoma
• Stage III Lung Cancer AJCC v8
• Stage IIIA Lung Cancer AJCC v8
• Stage IIIB Lung Cancer AJCC v8
• Stage IIIC Lung Cancer AJCC v8

Interventions

Type	Name	Description
BIOLOGICAL	Dostarlimab	Given IV
DRUG	Niraparib	Given PO

Timeline

• Start date: 2021-02-01
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2021-01-08
• Last updated: 2025-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study