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NCT06077760 · ClinicalTrials.gov registry record · Phase 3
A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)
A Phase 3 study of Non-Small Cell Lung Cancer, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 868
- Enrollment target
- 20
- Study locations
NCT06077760: Recruiting Phase 3 study of Non-Small Cell Lung Cancer, sponsored by Merck Sharp & Dohme.
NCT06077760 is a Phase 3 study of Non-Small Cell Lung Cancer that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 868 participants, above the 650-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (34% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06077760, a Phase 3 study of Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 868 participants
- Enrollment target
- 20
- Study locations
Study Summary
The goal of this study is to evaluate intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement \[N2\]) non-small cell lung cancer (NSCLC). The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.
Primary Outcome
DFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, as assessed by the investigator, or death due to any cause, whichever occurs first.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- OTHER Placebo
- BIOLOGICAL Intismeran autogene
Study Locations (20)
California
- UCLA Clinical & Translational Research Center (CTRC) ( Site 0059) - Los Angeles
- Hoag Memorial Hospital Presbyterian ( Site 4042) - Newport Beach
- Hoag Memorial Hospital Presbyterian ( Site 4048) - Newport Beach
- St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0074) - Orange
- University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0030) - Orange
Florida
- Mayo Clinic Florida ( Site 4043) - Jacksonville
- Miami Cancer Institute at Baptist Health, Inc. ( Site 4047) - Miami
- Mid Florida Hematology and Oncology Center ( Site 0014) - Orange City
- AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0013) - Orlando
- Moffitt Cancer Center ( Site 0078) - Tampa
Arizona
- The University of Arizona Cancer Center - North Campus ( Site 0071) - Tucson
- YUMA REGIONAL MEDICAL CENTER CANCER CENTER ( Site 0020) - Yuma
Georgia
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0012) - Marietta
- Southeastern Regional Medical Center ( Site 0098) - Newnan
Alaska
- Alaska Oncology and Hematology ( Site 0039) - Anchorage
Colorado
- UCHealth Memorial Hospital-Heme Onc ( Site 0052) - Colorado Springs
Idaho
- Beacon Cancer Care ( Site 0044) - Post Falls
Illinois
- Illinois Cancer Care ( Site 7003) - Peoria
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 868 participants |
| Start Date | 2023-12-06 |
| Est. Completion | 2035-12-21 |
| Phase | Phase 3 |
What NCT06077760 shows while recruiting
NCT06077760 is an interventional study that assigns participants to a tested intervention. The registered 868 participants enrollment target is mid-sized for trials with a published cap, above the 650-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (34% higher).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT06077760 names 20 study sites across 10 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT06077760 about?
NCT06077760 is a clinical study titled "A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)". The goal of this study is to evaluate intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement \[N2\]) non-small cell lung cancer (NSCLC). The primary hypothesis is that in...
What is the current status of trial NCT06077760?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 868 participants. The study started on 2023-12-06. Estimated completion is 2035-12-21.
What conditions does trial NCT06077760 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT06077760?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (OTHER), Intismeran autogene (BIOLOGICAL).
Who is sponsoring clinical trial NCT06077760?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06077760 being conducted?
This trial has 20 study locations across Alaska, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06077760's enrollment target sits among peer trials
868 29th of 454 higher than 426 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-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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