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Trials
A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)

trialsTrialRecruiting

A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)

A phase 2 trial of Raludotatug deruxtecan and Ifinatamab deruxtecan in non-small-cell lung cancer, run by Merck Sharp & Dohme LLC, now recruiting.

Also called: KEYMAKER-U01

Overview Connected5

Overview

A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01) is a phase 2 interventional study registered as NCT06780085 by Merck Sharp & Dohme LLC, with 96 participants planned, started 2025-05-13 and due to reach its primary completion in 2032-03-12. Interventions recorded: Raludotatug Deruxtecan, Ifinatamab Deruxtecan, Docetetaxel, 5-hydroxytryptamine subtype 3 receptor antagonist, Neurokinin-1 receptor antagonist and Corticosteroid.

Setting

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)

Phase

Phase 2

Sponsor

Merck Sharp & Dohme LLC

Registry

Started

2025-05-13

Enrolled

96 enrolled

Connected

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cancers

Non-small-cell lung cancer

drugs

Phase 3ADC

Ifinatamab deruxtecan

Phase 3ADC

Raludotatug deruxtecan

companies

Daiichi Sankyo Merck & Co. (MSD)

Evidence strength25/100 · Preliminary

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 2+15
96 enrolled+10
No structured primary endpoint0
Result: recruiting0
No independent replication recorded0

Formula disclosed on the evidence page.

ProvenanceLast edited 2026-09-18 · Jude Gomila · Trial acronyms for registry records · diff · file

Sources & links

ClinicalTrials.gov NCT06780085

Data

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Cancers

Non-small-cell lung cancer

Products

Raludotatug deruxtecan
Ifinatamab deruxtecan

Companies

Merck & Co. (MSD)
Daiichi Sankyo

Not yet reviewedNeeds expert (clinical) review. Review this page or see the review queue and roster.

Model panel commentary is coming to this page: machine commentary, not clinical review.

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