NCT04701307

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

Active, enrolled Phase 2 Last updated 15 December 2025

What this trial tests

Phase 2 trial testing Dostarlimab in Lung Small Cell Carcinoma in 48 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 February 2021

Primary endpoint
30 April 2026

30 April 2026

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	1 February 2021
Primary completion	30 April 2026
Estimated completion	30 April 2026
Sites	1 location across United States

Drugs / interventions tested

• Dostarlimab (DOSTARLIMAB) — full drug profile →
• Niraparib (niraparib) — full drug profile →

Conditions studied

• Lung Small Cell Carcinoma — all drugs for Lung Small Cell Carcinoma →
• Neuroendocrine Carcinoma — all drugs for Neuroendocrine Carcinoma →
• Stage III Lung Cancer AJCC v8 — all drugs for Stage III Lung Cancer AJCC v8 →
• Stage IIIA Lung Cancer AJCC v8 — all drugs for Stage IIIA Lung Cancer AJCC v8 →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Lung Small Cell Carcinoma or Neuroendocrine Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting DNA repair pathway in cancer: Mechanisms and clinical application.
   Wang M, Chen S, Ao D. · · 2021 · cited 84× · PMID 34977872 · DOI 10.1002/mco2.103
2. A Comprehensive Review on Neuroendocrine Neoplasms: Presentation, Pathophysiology and Management.
   Sultana Q, Kar J, Verma A, Sanghvi S, et al · · 2023 · cited 60× · PMID 37568540 · DOI 10.3390/jcm12155138
3. The role of DNA damage repair (DDR) system in response to immune checkpoint inhibitor (ICI) therapy.
   Shi C, Qin K, Lin A, Jiang A, et al · · 2022 · cited 60× · PMID 36071479 · DOI 10.1186/s13046-022-02469-0
4. PARP inhibitors as single agents and in combination therapy: the most promising treatment strategies in clinical trials for BRCA-mutant ovarian and triple-negative breast cancers.
   Luo L, Keyomarsi K. · · 2022 · cited 56× · PMID 35435784 · DOI 10.1080/13543784.2022.2067527
5. Advances in cervical cancer: current insights and future directions.
   Xu M, Cao C, Wu P, Huang X, et al · · 2025 · cited 55× · PMID 39611440 · DOI 10.1002/cac2.12629
6. Small cells - big issues: biological implications and preclinical advancements in small cell lung cancer.
   Solta A, Ernhofer B, Boettiger K, Megyesfalvi Z, et al · · 2024 · cited 30× · PMID 38395864 · DOI 10.1186/s12943-024-01953-9
7. Expanding Therapeutic Opportunities for Extrapulmonary Neuroendocrine Carcinoma.
   Frizziero M, Kilgour E, Simpson KL, Rothwell DG, et al · · 2022 · cited 30× · PMID 35091446 · DOI 10.1158/1078-0432.ccr-21-3058
8. Advances in Treatment of Recurrent Small Cell Lung Cancer (SCLC): Insights for Optimizing Patient Outcomes from an Expert Roundtable Discussion.
   Das M, Padda SK, Weiss J, Owonikoko TK. · · 2021 · cited 30× · PMID 34564806 · DOI 10.1007/s12325-021-01909-1