KEYMAKER-U01 Master Study: A Phase 2, Umbrella Study with Rolling Arms of Investigational Agents with either Pembrolizumab in Combination with Chemotherapy or with Pembrolizumab Alone in Patients with Advanced Non-small Cell Lung Cancer (NSCLC) KEYMAKER-U01 Substudy 2: A Phase 2, Umbrella Study with Rolling Arms of Investigational Agents in Combination with Pembrolizumab in Treatment Naïve Patients with PD-L1 Positive Advanced Non-small Cell Lung Cancer (NSCLC)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506933-32-00

Acronym

MK-3475-01B

Enrollment

Registered

2024-01-10

Start date

2020-10-20

Completion date

2025-10-24

Last updated

2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer (NSCLC)

Brief summary

Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

Detailed description

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), Number of Participants Who Experience One or More Adverse Events (AEs), Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)

Interventions

DRUGrolistobart

DRUGMK-4830

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	—

Secondary

Measure	Time frame
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), Number of Participants Who Experience One or More Adverse Events (AEs), Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)	—

Countries

Hungary, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026