KEYMAKER-U01 Substudy 01H: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants with Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518761-10-00

Acronym

MK-3475-01H

Enrollment

Registered

2025-08-13

Start date

2025-08-25

Completion date

Unknown

Last updated

2025-12-10

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

Brief summary

Objective Response (OR), Percentage of participants with at least one adverse event (AE), Percentage of participants who discontinued medication due to an AE

Detailed description

Duration Of Response (DOR), Progression-Free Survival (PFS), Overall Survival (OS)

Interventions

DRUGRaludotatug Deruxtecan

DRUGIfinatamab Deruxtecan

DRUGDOCETAXEL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective Response (OR), Percentage of participants with at least one adverse event (AE), Percentage of participants who discontinued medication due to an AE	—

Secondary

Measure	Time frame
Duration Of Response (DOR), Progression-Free Survival (PFS), Overall Survival (OS)	—

Countries

Germany, Greece, Hungary, Italy, Poland, Spain

Outcome results

None listed

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