Summary
Niraparib has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Lung Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Lung Cancer. ClinicalTrials.gov lists 8 registered trials linking Niraparib to Lung Cancer: 1 is currently recruiting; 2 are active or not yet recruiting; 2 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT03654833). It plans or enrolled 186 participants. Registration activity spans 2017 to 2023. The literature layer holds 4 publications for this pair: 4 clinical trial publications. Publication years run from 2013 to 2024. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
The RepurpOS disease-intelligence file for Lung Cancer ranks 465 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous regression is rare (<0.5% of cases); 5-year survival without treatment: <5% for advanced NSCLC; ~20% for stage I-II with surgery.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 51.0 (trials 23.0, literature 8.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 2 active / not yet recruiting, 2 completed, 3 other |
| Linked publications | 4 (4 clinical trial publications) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | BRCA1 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT04701307 | Niraparib and Dostarlimab for the Treatment of Small Cell Lung Cancer and Other High-Grade Neuroendocrine Carcinomas 2021 | active, not recruiting | Phase 2 | 48 |
| NCT03308942 | Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants 2017 | completed | Phase 2 | 53 |
| NCT05455424 | Niraparib Efficacy in Patient With Unresectable Mesothelioma 2022 | completed | Phase 2 | 88 |
| NCT05718323 | Niraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLC 2023 | recruiting | Phase 2 | 44 |
| NCT05169437 | Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors 2022 | terminated | Phase 2 | 22 |
| NCT03654833 | Mesothelioma Stratified Therapy (MiST) : A Multi-drug Phase II Trial in Malignant Mesothelioma 2019 | status unknown | Phase 2 | 186 |
| NCT03891615 | Niraparib in Combination With Osimertinib in EGFR-Mutated Advanced Lung Cancer 2019 | status unknown | Phase 1 | 30 |
| NCT03830918 | Niraparib, Temozolomide and Atezolizumab in Treating Patients With Advanced Solid Tumors and Extensive-Stage Small Cell Lung Cancer With a Complete or Partial Response to Platinum-Based First-Line Chemotherapy 2019 | active, not recruiting | PHASE1, PHASE2 | 59 |
Published literature
- Clinical trial publication Niraparib plus Dostarlimab in Pleural Mesothelioma or Non-Small Cell Lung Cancer Harboring HRR Mutations: Interim Results of the UNITO-001 Phase II Prospective TrialPassiglia F, Righi L, Bironzo P et al. · Clinical cancer research : an official journal of the American Association for Cancer Research · 2024 · PMID 38109438
- Clinical trial publication JASPER: Phase 2 trial of first-line niraparib plus pembrolizumab in patients with advanced non-small cell lung cancerRamalingam SS, Thara E, Awad MM et al. · Cancer · 2022 · PMID 34478166
- Clinical trial publication Efficacy and Safety of Niraparib as Maintenance Treatment in Patients With Extensive-Stage SCLC After First-Line Chemotherapy: A Randomized, Double-Blind, Phase 3 StudyAi X, Pan Y, Shi J et al. · Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2021 · PMID 33915252
- Clinical trial publication The poly(ADP-ribose) polymerase inhibitor niraparib (MK4827) in BRCA mutation carriers and patients with sporadic cancer: a phase 1 dose-escalation trialSandhu SK, Schelman WR, Wilding G et al. · The Lancet. Oncology · 2013 · PMID 23810788
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target BRCA1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Niraparib approved for Lung Cancer?
Niraparib has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Lung Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Lung Cancer. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Niraparib in clinical trials for Lung Cancer?
ClinicalTrials.gov lists 8 registered trials linking Niraparib to Lung Cancer: 1 is currently recruiting; 2 are active or not yet recruiting; 2 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT03654833). It plans or enrolled 186 participants. Registration activity spans 2017 to 2023.
What does the evidence show for Niraparib in Lung Cancer?
Niraparib has 2 completed trials and 4 linked publications for Lung Cancer. Completed trials may or may not have posted results; follow the NCT links to check. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target BRCA1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.