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NCT04165070 · ClinicalTrials.gov registry record · Phase 1
KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)
A Phase 1 study of Carcinoma, Non-Small Cell Lung, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 450
- Enrollment target
- 20
- Study locations
NCT04165070 is a Phase 1 study of Carcinoma, Non-Small Cell Lung that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 450 participants, above the 320-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (41% higher). The trial reports 20 study locations across 17 states.
The verdict
NCT04165070, a Phase 1 study of Carcinoma, Non-Small Cell Lung, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 450 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) with or without chemotherapy in combination with vibostolimab (MK-7684), boserolimab (MK-5890), MK-4830, MK-0482, I-DXd, or HER3-DXd in treatment-naïve participants with advanced squamous or non-squamous NSCLC. This study is one of the pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Carboplatin
- DRUG Pemetrexed
- DRUG Paclitaxel
- BIOLOGICAL Vibostolimab
Study Locations (20)
California
- City of Hope ( Site 0014) - Duarte
- UCSF Medical Center at Mission Bay ( Site 0007) - San Francisco
Massachusetts
- Massachusetts General Hospital ( Site 0003) - Boston
- Dana Farber Cancer Institute ( Site 0002) - Boston
Ohio
- Cleveland Clinic Main ( Site 0006) - Cleveland
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0015) - Columbus
Arizona
- Banner MD Anderson Cancer Center ( Site 0001) - Gilbert
District of Columbia
- Georgetown University ( Site 0036) - Washington D.C.
Kentucky
- University of Kentucky Markey Cancer Center ( Site 0019) - Lexington
Maryland
- MedStar Franklin Square Medical Center ( Site 0033) - Baltimore
Nebraska
- Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031) - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2019-12-19 |
| Est. Completion | 2032-02-13 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04165070
The ClinicalTrials.gov registry entry for NCT04165070 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 320-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (41% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04165070 reports 20 study locations spanning 17 distinct geographic areas - top geographies include California, Massachusetts, Ohio.
Frequently Asked Questions
What is clinical trial NCT04165070 about?
NCT04165070 is a clinical study titled "KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)". The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) with or without chemotherapy in combination with vibostolimab (MK-7684), boserolimab (MK-5890), MK-4830, MK-0482, I-DXd, or HER3-DXd in treatment-naïve participants with advanced squamous or non-squamous NSCLC....
What is the current status of trial NCT04165070?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 450 participants. The study started on 2019-12-19. Estimated completion is 2032-02-13.
What conditions does trial NCT04165070 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.
What interventions are being tested in trial NCT04165070?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Carboplatin (DRUG), Pemetrexed (DRUG), Paclitaxel (DRUG), Vibostolimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04165070?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04165070 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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