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NCT03302234 · ClinicalTrials.gov registry record · Phase 3
Study of Pembrolizumab Given With Ipilimumab or Placebo in Participants With Untreated Metastatic Non-Small Cell Lung Cancer (NSCLC) (MK-3475-598/KEYNOTE-598)
A Phase 3 study of Carcinoma, Non-Small Cell Lung, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 568
- Enrollment target
- 20
- Study locations
NCT03302234: Completed Phase 3 study of Carcinoma, Non-Small Cell Lung, sponsored by Merck Sharp & Dohme.
NCT03302234 is a Phase 3 study of Carcinoma, Non-Small Cell Lung that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 568 participants, above the 319-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (78% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03302234, a Phase 3 study of Carcinoma, Non-Small Cell Lung, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 568 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine the efficacy of pembrolizumab given in combination with either ipilimumab or placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC). The primary hypothesis of this study is that overall survival (OS) and/or progression-free survival (PFS) is prolonged in participants who receive pembrolizumab and ipilimumab compared to those who receive pembrolizumab and placebo. With Amendment 6 (effective date: 11-Dec-2020), active participants, investigator, and sponsor personnel or delegate(s) involved in the treatment administration or clinical evaluation of the participants will be unblinded. Participants will discontinue ipilimumab and placebo and participants who remain on treatment will receive open-label pembrolizumab only.
Primary Outcome
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of analysis were censored at the date of last known contact. The median survival (in months) and the associated 95% confidence intervals (CIs) were reported using Kaplan-Meier method was used. Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- OTHER Placebo
- BIOLOGICAL Ipilimumab
Study Locations (20)
California
- Disney Family Cancer Center ( Site 0035) - Burbank
- Pacific Cancer Care ( Site 0001) - Monterey
- John Wayne Cancer Institute ( Site 0021) - Santa Monica
Texas
- Texas Oncology-Arlington South ( Site 8006) - Arlington
- Texas Oncology-Methodist Dallas Cancer Center ( Site 8000) - Dallas
- Texas Oncology-Flower Mound ( Site 8007) - Flower Mound
Massachusetts
- Boston Medical Center ( Site 0025) - Boston
- Lahey Hospital & Medical Center ( Site 0020) - Burlington
Ohio
- The Ohio State University Wexner Medical Center ( Site 0016) - Columbus
- Mid Ohio Oncology/Hematology Inc. ( Site 0003) - Columbus
Tennessee
- University of Tennessee Erlanger Oncology & Hematology ( Site 0026) - Chattanooga
- Tennessee Cancer Specialists ( Site 0017) - Knoxville
Arizona
- Mayo Clinic Cancer Center ( Site 0007) - Phoenix
Florida
- Florida Hospital Cancer Institute ( Site 0009) - Orlando
Kentucky
- Mercy Health-Paducah Medical Oncology and Hematology ( Site 0018) - Paducah
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 568 participants |
| Start Date | 2017-12-14 |
| Est. Completion | 2022-09-07 |
| Phase | Phase 3 |
What the finished NCT03302234 record still lists
NCT03302234 is an interventional study that assigns participants to a tested intervention. The registered 568 participants enrollment target is mid-sized for trials with a published cap, above the 319-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (78% higher).
The record links to 1 condition, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03302234 names 20 study sites across 13 states, led by California, Texas, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03302234 about?
NCT03302234 is a clinical study titled "Study of Pembrolizumab Given With Ipilimumab or Placebo in Participants With Untreated Metastatic Non-Small Cell Lung Cancer (NSCLC) (MK-3475-598/KEYNOTE-598)". The purpose of this study is to determine the efficacy of pembrolizumab given in combination with either ipilimumab or placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC). The primary hypothesis of this study is that overall survival (OS) and/or progres...
What is the current status of trial NCT03302234?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 568 participants. The study started on 2017-12-14. Estimated completion is 2022-09-07.
What conditions does trial NCT03302234 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.
What interventions are being tested in trial NCT03302234?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (OTHER), Ipilimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03302234?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03302234 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Kentucky, Maine. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03302234's enrollment target sits among peer trials
568 25th of 130 higher than 106 of 130 other Carcinoma, Non-Small Cell Lung trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung 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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