ClinicalTrials.gov record
Recruiting Phase 2 Interventional

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)

ClinicalTrials.gov ID: NCT06780098

Public ClinicalTrials.gov record NCT06780098. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 6, 2026, 8:30 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Study identification

NCT ID
NCT06780098
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Enrollment
144 participants

Conditions and interventions

Conditions

Interventions

  • Docetaxel Drug
  • I-DXD Biological
  • R-DXD Biological
  • Rescue Medication Drug
  • Rescue Medications Drug

Drug · Biological

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 27, 2025
Primary completion
Mar 1, 2032
Completion
Mar 1, 2032
Last update posted
Apr 30, 2026

2025 – 2032

United States locations

U.S. sites
3
U.S. states
3
U.S. cities
3
Facility City State ZIP Site status
University of Kentucky Chandler Medical Center ( Site 0019) Lexington Kentucky 40536-0293 Recruiting
MedStar Franklin Square Medical Center ( Site 0033) Baltimore Maryland 21237 Recruiting
Texas Oncology - DFW ( Site 8003) Dallas Texas 75246-2046 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 37 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06780098, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 30, 2026 · Synced May 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06780098 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →