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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)

NCT04165070 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2026-05-18

No results posted yet for this 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

  • Carcinoma, Non-Small-Cell Lung

Interventions

BIOLOGICAL

Pembrolizumab

IV infusion

DRUG

Carboplatin

IV infusion

DRUG

Paclitaxel

IV infusion

DRUG

Pemetrexed

IV infusion

BIOLOGICAL

Vibostolimab

IV infusion

BIOLOGICAL

Boserolimab

IV infusion

BIOLOGICAL

MK-4830

IV infusion

BIOLOGICAL

MK-0482

IV Infusion

BIOLOGICAL

Ifinatamab Deruxtecan (I-DXd)

IV infusion

BIOLOGICAL

HER3-DXd

IV Infusion

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-19
Primary Completion
2032-02-13
Completion
2032-02-13
FDA Drug
Yes

Countries

  • United States
  • Hungary
  • Israel
  • Italy
  • Poland
  • South Korea
  • Spain
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04165070 on ClinicalTrials.gov