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NCT04624204 · ClinicalTrials.gov registry record · Phase 3
Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)
A Phase 3 study of Small-cell Lung Cancer, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 672
- Enrollment target
- 20
- Study locations
NCT04624204: Active Phase 3 study of Small-cell Lung Cancer, sponsored by Merck Sharp & Dohme.
NCT04624204 is a Phase 3 study of Small-cell Lung Cancer that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 672 participants, above the 224-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (200% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04624204, a Phase 3 study of Small-cell Lung Cancer, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 672 participants
- Enrollment target
- 20
- Study locations
Study Summary
Researchers are looking for new ways to treat Limited-Stage Small Cell Lung Cancer (LS-SCLC), a type of lung cancer that has not spread from the lung to other parts of the body. The purpose of this study is to learn if pembrolizumab and olaparib, when given with chemotherapy and radiation treatment (CRT), can be effective in treating LS-SCLC. The researchers want to know if participants who receive CRT and pembrolizumab, with or without olaparib, have a longer overall survival compared to participants who only receive CRT.
Primary Outcome
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) is the time from randomization to progression or death due to any cause, whichever occurs first.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab 200 mg
- BIOLOGICAL Pembrolizumab 400 mg
- DRUG Pembrolizumab placebo (saline)
- DRUG Olaparib 300 mg BID
Study Locations (20)
New Jersey
- Memorial Sloan Kettering - Basking Ridge ( Site 0133) - Basking Ridge
- John Theurer Cancer Center ( Site 0064) - Hackensack
- Memorial Sloan Kettering - Monmouth ( Site 0135) - Middletown
- Memorial Sloan Kettering - Bergen ( Site 0130) - Montvale
- Rutgers Cancer Institute of New Jersey ( Site 0123) - New Brunswick
New York
- Memorial Sloan Kettering- Commack ( Site 0132) - Commack
- Memorial Sloan Kettering - Westchester-Thoracic Oncology ( Site 0134) - Harrison
- Memorial Sloan Kettering Cancer Center ( Site 0069) - New York
Arizona
- Ironwood Cancer & Research Centers ( Site 0007) - Chandler
California
- Loma Linda University Cancer Center ( Site 0011) - Loma Linda
District of Columbia
- Georgetown University ( Site 0017) - Washington D.C.
Florida
- Moffitt Cancer Center ( Site 0137) - Tampa
Illinois
- University of Chicago Medical Center ( Site 0136) - Chicago
Indiana
- Fort Wayne Medical Oncology and Hematology ( Site 0034) - Fort Wayne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 672 participants |
| Start Date | 2020-12-08 |
| Est. Completion | 2027-10-28 |
| Phase | Phase 3 |
What the registry record for NCT04624204 still lists
NCT04624204 is an interventional study that assigns participants to a tested intervention. The registered 672 participants enrollment target is mid-sized for trials with a published cap, above the 224-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (200% higher).
The record links to 1 condition, with Small-cell Lung Cancer appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab 200 mg is the first listed.
NCT04624204 names 20 study sites across 14 states, led by New Jersey, New York, Arizona.
Frequently Asked Questions
What is clinical trial NCT04624204 about?
NCT04624204 is a clinical study titled "Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)". Researchers are looking for new ways to treat Limited-Stage Small Cell Lung Cancer (LS-SCLC), a type of lung cancer that has not spread from the lung to other parts of the body. The purpose of this study is to learn if pembrolizumab and olaparib, when given with chemotherapy and radiation treatment ...
What is the current status of trial NCT04624204?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 672 participants. The study started on 2020-12-08. Estimated completion is 2027-10-28.
What conditions does trial NCT04624204 study?
This clinical trial studies the following conditions: Small-cell Lung Cancer.
What interventions are being tested in trial NCT04624204?
The interventions under investigation include: Pembrolizumab 200 mg (BIOLOGICAL), Pembrolizumab 400 mg (BIOLOGICAL), Pembrolizumab placebo (saline) (DRUG), Olaparib 300 mg BID (DRUG).
Who is sponsoring clinical trial NCT04624204?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04624204 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Small-cell Lung Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04624204's enrollment target sits among peer trials
672 6th of 79 higher than 74 of 79 other Small-cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Small-cell Lung Cancer 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.
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