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Trials
Substudy 01I: A Study of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01I/KEYMAKER-U01I)

trialsTrialRecruiting

Substudy 01I: A Study of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01I/KEYMAKER-U01I)

A phase 2 trial of Docetaxel in advanced solid tumours, run by Merck Sharp & Dohme LLC, now recruiting.

Also called: KEYMAKER-U01I

Overview Connected5

Overview

Substudy 01I: A Study of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01I/KEYMAKER-U01I) is a phase 2 interventional study registered as NCT06780098 by Merck Sharp & Dohme LLC, with 144 participants planned, started 2025-05-28 and due to reach its primary completion in 2032-03-02. Interventions recorded: R-DXD, I-DXD, Docetaxel, Rescue Medications and Rescue Medication.

Setting

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)

Phase

Phase 2

Sponsor

Merck Sharp & Dohme LLC

Registry

Started

2025-05-28

Enrolled

144 enrolled

Connected

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cancers

Metastatic cancer (cancer that has spread)

technologies

Cytotoxic chemotherapy

drugs

ApprovedCytotoxic chemotherapy (taxane)

Docetaxel · Taxotere (generic)

companies

Daiichi Sankyo Merck & Co. (MSD)

Evidence strength31/100 · Emerging

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

Phase 2+15
144 enrolled+11
No structured primary endpoint0
Result: recruiting0
No independent replication recorded0
A linked product is approved+5

Formula disclosed on the evidence page.

ProvenanceLast edited 2026-09-22 · Jude Gomila · Wave 2 corpus-only joins applied · diff · file

Sources & links

ClinicalTrials.gov NCT06780098

Data

JSON ·

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Cancers

Metastatic cancer (cancer that has spread)

Technologies

Cytotoxic chemotherapy

Products

Docetaxel

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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