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)
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Official title
A Phase 3 Study of Pembrolizumab in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Followed by Pembrolizumab and Maintenance Olaparib vs Maintenance Pemetrexed in the First-Line Treatment of Participants With Metastatic Nonsquamous 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, 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).
Study identification
- NCT ID
- NCT03976323
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,003 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab Biological
- Pemetrexed Drug
- Carboplatin Drug
- Cisplatin Drug
- Olaparib 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 28, 2019 (Actual)
- Primary completion
- Feb 7, 2024 (Actual)
- Completion
- Jan 30, 2026 (Actual)
- Last update posted
- Sep 28, 2026
2019 – 2026
United States locations
- U.S. sites
- 20
- U.S. states
- 14
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Oncology Bruno Cancer Center ( Site 0001) | Birmingham | Alabama | 35205 | — |
| Northwest Alabama Cancer Center, PC ( Site 0002) | Muscle Shoals | Alabama | 35661 | — |
| 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 | — |
| Moffitt Cancer Center ( Site 0024) | Tampa | Florida | 33612 | — |
| Columbus Regional Research Institute ( Site 0098) | Columbus | Georgia | 31904 | — |
| Mount Sinai Hospital Medical Center ( Site 0032) | Chicago | Illinois | 60608 | — |
| Oncology of Northshore ( Site 0033) | Rolling Meadows | Illinois | 60008 | — |
| Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0036) | Merrillville | Indiana | 46410 | — |
| Medstar Good Samaritan Hospital ( Site 0040) | Baltimore | Maryland | 21239 | — |
| Barbara Ann Karmanos Cancer Institute ( Site 0041) | Detroit | Michigan | 48201 | — |
| Hattiesburg Clinic ( Site 0045) | Hattiesburg | Mississippi | 39401 | — |
| Frontier Oncology ( Site 0080) | Billings | Montana | 59102 | — |
| Bozeman Health Deaconness Cancer Center ( Site 0046) | Bozeman | Montana | 59715 | — |
| Waverly Hematology Oncology ( Site 0081) | Cary | North Carolina | 27518 | — |
| Thompson Cancer Survival Center ( Site 2812) | Knoxville | Tennessee | 37916 | — |
| University of Tennessee Medical Center Knoxville ( Site 0060) | Knoxville | Tennessee | 37920 | — |
| Renovatio Clinical ( Site 0062) | The Woodlands | Texas | 77380 | — |
| Cancer Care Northwest ( Site 0071) | 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 158 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03976323, 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 Sep 28, 2026 · Synced Nov 15, 2026
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