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NCT03308942 · ClinicalTrials.gov registry record · Phase 2
Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants
A Phase 2 study, sponsored by Tesaro.
- Completed
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
NCT03308942: Completed Phase 2 study, sponsored by Tesaro.
NCT03308942 is a Phase 2 study that has completed, run by Tesaro. The registered enrollment target is 53 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03308942, a Phase 2 study, has completed, sponsored by Tesaro.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
Study Summary
This is a multicenter, open-label, phase 2 study to evaluate the efficacy and safety of niraparib alone and in combination with PD-1 inhibitors in participants with locally advanced and metastatic non-small cell lung cancer (NSCLC). The study will consist of 2 stages. In stage 1, participants from Cohorts 1 and 2 will receive niraparib plus PD-1 inhibitor; pembrolizumab and participants from Cohort 3 will receive niraparib alone. In Stage 2, participants from Cohorts 1A and 2A will receive niraparib plus the PD-1 inhibitor, TSR-042 (Dostarlimab).
Primary Outcome
ORR is the percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) in the analysis population where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeters (mm) in the short axis. PR=At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. Tumor assessment was done by the Investigator per Response Evaluation Cr
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Niraparib
- BIOLOGICAL TSR-042 (Dostarlimab)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2017-09-29 |
| Est. Completion | 2021-08-31 |
| Phase | Phase 2 |
What the finished NCT03308942 record still lists
NCT03308942 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03308942 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03308942 about?
NCT03308942 is a clinical study titled "Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants". This is a multicenter, open-label, phase 2 study to evaluate the efficacy and safety of niraparib alone and in combination with PD-1 inhibitors in participants with locally advanced and metastatic non-small cell lung cancer (NSCLC). The study will consist of 2 stages. In stage 1, participants from C...
What is the current status of trial NCT03308942?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2017-09-29. Estimated completion is 2021-08-31.
What interventions are being tested in trial NCT03308942?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Niraparib (DRUG), TSR-042 (Dostarlimab) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03308942?
This trial is sponsored by Tesaro, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03308942's enrollment target sits among peer trials
53 1171st of 2000 higher than 820 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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