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NCT03976362 · ClinicalTrials.gov registry record · Phase 3
A Study of Pembrolizumab (MK-3475) With or Without Maintenance Olaparib in First-line Metastatic Squamous Non-small Cell Lung Cancer (NSCLC, MK-7339-008/KEYLYNK-008)
A Phase 3 study of Carcinoma, Squamous Cell, Non-small-cell Lung, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 851
- Enrollment target
- 20
- Study locations
NCT03976362: Completed Phase 3 study of Carcinoma, Squamous Cell, Non-small-cell Lung, sponsored by Merck Sharp & Dohme.
NCT03976362 is a Phase 3 study of Carcinoma, Squamous Cell, Non-small-cell Lung that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 851 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03976362, a Phase 3 study of Carcinoma, Squamous Cell, Non-small-cell Lung, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 851 participants
- Enrollment target
- 20
- Study locations
Study Summary
The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs. pembrolizumab plus maintenance olaparib placebo for the treatment of squamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to progression-free survival (PFS) per RECIST 1.1 by blinded independent clinical review (BICR). 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to overall survival (OS). As of Amendment 07, there will be no further analyses for OS and patient-reported outcome assessments.
Primary Outcome
Progression-free Survival was defined as the time from the date of randomization until either documented disease progression or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, progressive disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Carboplatin
- DRUG Olaparib
- DRUG Paclitaxel
- DRUG Nab-paclitaxel
Study Locations (20)
Florida
- Boca Raton Regional Hospital ( Site 0018) - Boca Raton
- Mid-Florida Cancer Centers ( Site 0022) - Orange City
- H. Lee Moffitt Cancer Center and Research Institute ( Site 0024) - Tampa
Illinois
- Mount Sinai Hospital Medical Center ( Site 0035) - Chicago
- Oncology of Northshore ( Site 0036) - Rolling Meadows
Montana
- Frontier Oncology ( Site 0052) - Billings
- Bozeman Health Deaconness Cancer Center ( Site 0053) - Bozeman
Buenos Aires
- Hospital Italiano Regional del Sur ( Site 0509) - Bahía Blanca
- Instituto de Investigaciones Clinicas Mar del Plata ( Site 0516) - Mar del Plata
Alabama
- Alabama Oncology Bruno Cancer Center ( Site 0001) - Birmingham
California
- Disney Family Cancer Center ( Site 0005) - Burbank
Georgia
- Columbus Regional Research Institute ( Site 0099) - Columbus
Indiana
- Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0039) - Merrillville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 851 participants |
| Start Date | 2019-06-28 |
| Est. Completion | 2026-01-30 |
| Phase | Phase 3 |
What the finished NCT03976362 record still lists
NCT03976362 is an interventional study that assigns participants to a tested intervention. The registered 851 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% higher).
The record links to 1 condition, with Carcinoma, Squamous Cell, Non-small-cell Lung appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03976362 names 20 study sites across 15 states, led by Florida, Illinois, Montana.
Frequently Asked Questions
What is clinical trial NCT03976362 about?
NCT03976362 is a clinical study titled "A Study of Pembrolizumab (MK-3475) With or Without Maintenance Olaparib in First-line Metastatic Squamous Non-small Cell Lung Cancer (NSCLC, MK-7339-008/KEYLYNK-008)". The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs. pembrolizumab plus maintenance olaparib placebo for the treatment of squamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance o...
What is the current status of trial NCT03976362?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 851 participants. The study started on 2019-06-28. Estimated completion is 2026-01-30.
What conditions does trial NCT03976362 study?
This clinical trial studies the following conditions: Carcinoma, Squamous Cell, Non-small-cell Lung.
What interventions are being tested in trial NCT03976362?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Carboplatin (DRUG), Olaparib (DRUG), Paclitaxel (DRUG), Nab-paclitaxel (DRUG).
Who is sponsoring clinical trial NCT03976362?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03976362 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03976362's enrollment target sits among peer trials
851 386th of 2000 higher than 1,614 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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