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)
Public ClinicalTrials.gov record NCT03976362. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance Olaparib in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03976362
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 851 participants
Conditions and interventions
Interventions
- Pembrolizumab Biological
- Carboplatin Drug
- Paclitaxel Drug
- Nab-paclitaxel Drug
- Olaparib Drug
- Placebo Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 27, 2019
- Primary completion
- Sep 20, 2023
- Completion
- Jan 29, 2026
- Last update posted
- Feb 24, 2026
2019 – 2026
United States locations
- U.S. sites
- 18
- U.S. states
- 14
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Oncology Bruno Cancer Center ( Site 0001) | Birmingham | Alabama | 35205 | — |
| Disney Family Cancer Center ( Site 0005) | Burbank | California | 91505 | — |
| Boca Raton Regional Hospital ( Site 0018) | Boca Raton | Florida | 33486 | — |
| Mid-Florida Cancer Centers ( Site 0022) | Orange City | Florida | 32763 | — |
| H. Lee Moffitt Cancer Center and Research Institute ( Site 0024) | Tampa | Florida | 33612 | — |
| Columbus Regional Research Institute ( Site 0099) | Columbus | Georgia | 31904 | — |
| Mount Sinai Hospital Medical Center ( Site 0035) | Chicago | Illinois | 60608 | — |
| Oncology of Northshore ( Site 0036) | Rolling Meadows | Illinois | 60008 | — |
| Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0039) | Merrillville | Indiana | 46410 | — |
| MedStar Franklin Square Medical Center ( Site 0044) | Baltimore | Maryland | 21237 | — |
| Barbara Ann Karmanos Cancer Institute ( Site 0046) | Detroit | Michigan | 48201 | — |
| Hattiesburg Clinic ( Site 0051) | Hattiesburg | Mississippi | 39401 | — |
| Frontier Oncology ( Site 0052) | Billings | Montana | 59102 | — |
| Bozeman Health Deaconness Cancer Center ( Site 0053) | Bozeman | Montana | 59715 | — |
| Waverly Hematology Oncology ( Site 0054) | Cary | North Carolina | 27518 | — |
| Thompson Cancer Survival Center ( Site 2812) | Knoxville | Tennessee | 37804 | — |
| Renovatio Clinical ( Site 0074) | The Woodlands | Texas | 77380 | — |
| Cancer Care Northwest ( Site 0083) | Spokane Valley | Washington | 99216 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 160 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03976362, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 24, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03976362 live on ClinicalTrials.gov.