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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: Recruiting Phase 1 study of Carcinoma, Non-Small Cell Lung, sponsored by Merck Sharp & Dohme.

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. According to ClinicalTrials.gov, the official US trial registry.

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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).

Primary Outcome

ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR will be reported.

Conditions Studied

Carcinoma, Non-Small Cell Lung

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

FieldValue
Enrollment Target 450 participants
Start Date 2019-12-19
Est. Completion 2032-02-13
Phase Phase 1
Merck Sharp & Dohme

558 total trials

What NCT04165070 shows while recruiting

NCT04165070 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, above the 320-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (41% higher).

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 names 20 study sites across 17 states, led by 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.

Learn More About Clinical Trials

Similar trials for Carcinoma, Non-Small Cell Lung

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 NCT04165070's enrollment target sits among peer trials

450 33rd of 130 higher than 98 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT04165070

Source: ClinicalTrials.gov NCT04165070, the US trial registry maintained by the National Library of Medicine. NCT04165070 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.