Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04701307 · ClinicalTrials.gov registry record · Phase 2
Niraparib and Dostarlimab for the Treatment of Small Cell Lung Cancer and Other High-Grade Neuroendocrine Carcinomas
A Phase 2 study of Stage III Lung Cancer AJCC v8 and Stage IIIB Lung Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT04701307: Active Phase 2 study of Stage III Lung Cancer AJCC v8 and Stage IIIB Lung Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
NCT04701307 is a Phase 2 study of Stage III Lung Cancer AJCC v8 and Stage IIIB Lung Cancer AJCC v8 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 48 participants, below the 99-participant average among 40 other Stage III Lung Cancer AJCC v8 trials with a reported enrollment target (52% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04701307, a Phase 2 study of Stage III Lung Cancer AJCC v8 and Stage IIIB Lung Cancer AJCC v8, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Defined as the number (or fraction) of patients who are alive without evidence of progression at 6 months from initiation of therapy. Progression will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version (v.)1.1 criteria using investigator's review. As there is no comparator arm, the rates will be considered in the context of historical controls. Will be performed using Kaplan-Meier methods for each cohort. Quartiles (i.e. 25th percentile, median, 75th percentile) and ass
Conditions Studied
Interventions
- DRUG Niraparib
- BIOLOGICAL Dostarlimab
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2021-02-01 |
| Est. Completion | 2026-04-30 |
| Phase | Phase 2 |
What the registry record for NCT04701307 still lists
NCT04701307 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 99-participant average among 40 other Stage III Lung Cancer AJCC v8 trials with a reported enrollment target (52% lower).
The record links to 6 conditions, with Stage III Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 2 interventions - of which Niraparib is the first listed.
NCT04701307 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04701307 about?
NCT04701307 is a clinical study titled "Niraparib and Dostarlimab for the Treatment of Small Cell Lung Cancer and Other High-Grade Neuroendocrine Carcinomas". 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 cance...
What is the current status of trial NCT04701307?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2021-02-01. Estimated completion is 2026-04-30.
What conditions does trial NCT04701307 study?
This clinical trial studies the following conditions: Stage III Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Neuroendocrine Carcinoma.
What interventions are being tested in trial NCT04701307?
The interventions under investigation include: Niraparib (DRUG), Dostarlimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04701307?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04701307 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage III Lung Cancer AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04701307's enrollment target sits among peer trials
48 20th of 40 higher than 21 of 40 other Stage III Lung Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage III Lung Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Defactinib, Avutometinib and Nivolumab for the Treatment of Anti-PD1 Refractory LKB1-Mutant Advanced Non-Small Cell Lung Cancer
RECRUITING · Phase 2
-
Local Consolidative Therapy and Durvalumab for Oligoprogressive and Polyprogressive Stage III NSCLC After Chemoradiation and Anti-PD-L1 Therapy
RECRUITING · Phase 2
-
Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer
RECRUITING · Phase 2
-
Diclofenac for the Treatment of Patients With Metastatic Non-small Cell Lung Cancer on Single Agent Immunotherapy
RECRUITING · Phase 2
-
GT103 in Combination With Pembrolizumab for the Treatment of Advanced or Metastatic STK11 Mutant Non-Small Cell Lung Cancer
RECRUITING · Phase 2
-
Canakinumab for the Prevention of Lung Cancer, the Can-Prevent-Lung Trial
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01765777 · 48 participants · NA
Efficacy of Osteopathic Manipulative Medicine (OMM) and Phototherapy for Patients With Chronic Lower Back Pain
- NCT03073343 · 48 participants · NA
A Prospective, Randomized, Open Label Trial of Two Doses of Oral Betaine
- NCT03431064 · 48 participants
Lung Recruitment Maneuver as a Potential Predictor of Fluid Responsiveness in Mechanically Ventilated Pediatric Patients
- NCT03514602 · 48 participants · NA
Maternal Smoking Cessation and Pediatric Obesity Prevention
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI