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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518839-11-00

Acronym

MK-3475-01I

Enrollment

Registered

2025-08-13

Start date

2025-08-25

Completion date

Unknown

Last updated

2026-01-19

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

Conditions

Stage IV Squamous Non-Small Cell Lung Cancer

Brief summary

Objective Response Rate (ORR), Number of participants who experience one or more adverse events (AEs), Number of participants who discontinue study intervention due to an AE

Detailed description

Duration of Response (DOR), Progression-free Survival (PFS), Overall Survival (OS)

Interventions

DRUGIfinatamab Deruxtecan

DRUGDOCETAXEL

DRUGRaludotatug Deruxtecan

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective Response Rate (ORR), Number of participants who experience one or more adverse events (AEs), Number of participants who discontinue study intervention 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