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NCT03976323 · ClinicalTrials.gov registry record · Phase 3
Study of Pembrolizumab With Maintenance Olaparib or Maintenance Pemetrexed in First-line (1L) Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC) (MK-7339-006, KEYLYNK-006)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,003
- Enrollment target
NCT03976323 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 1,003 participants.
The verdict
NCT03976323, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,003 participants
- Enrollment target
Study Summary
The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, versus (vs) pembrolizumab plus maintenance pemetrexed for the treatment of non-squamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent clinical review (BICR) and 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to overall survival (OS).
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Pemetrexed
- DRUG Olaparib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,003 participants |
| Start Date | 2019-06-28 |
| Est. Completion | 2026-01-29 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03976323
The ClinicalTrials.gov registry entry for NCT03976323 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,003 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03976323 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03976323 about?
NCT03976323 is a clinical study titled "Study of Pembrolizumab With Maintenance Olaparib or Maintenance Pemetrexed in First-line (1L) Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC) (MK-7339-006, KEYLYNK-006)". The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, versus (vs) pembrolizumab plus maintenance pemetrexed for the treatment of non-squamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintena...
What is the current status of trial NCT03976323?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,003 participants. The study started on 2019-06-28. Estimated completion is 2026-01-29.
What interventions are being tested in trial NCT03976323?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Carboplatin (DRUG), Cisplatin (DRUG), Pemetrexed (DRUG), Olaparib (DRUG).
Who is sponsoring clinical trial NCT03976323?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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