NCT04165070

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)

KEYMAKER-U01 Substudy 01A: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents With Pembrolizumab With or Without Chemotherapy in Treatment-Naive Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The master screening protocol is MK-3475-U01 (KEYMAKER-U01) - NCT04165798

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-12-19
• Primary completion: 2032-02-13
• Completion: 2032-02-13
• First posted: 2019-11-15
• Last updated: 2026-03-16

Locations

46 sites across 9 countries: United States, Hungary, Israel, Italy, Poland, South Korea, Spain, Taiwan, Ukraine

Regulatory

• FDA-regulated drug study