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KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Previously Treated Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

Researchers want to learn if MK-1084, the study medicine, can treat advanced or metastatic non-squamous NSCLC. MK-1084 is a targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread. The goals of this study are to learn: * About the safety of MK-1084 and if people tolerate it when taken with other treatments * How many people have the cancer respond (get smaller or go away) to the treatments

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ The main inclusion criteria include but are not limited to the following:

• Has histologically or cytologically confirmed diagnosis of advanced or metastatic non-squamous non-small cell lung cancer (NSCLC)

• Has tumor tissue or circulating tumor deoxyribonucleic acid (ctDNA) that demonstrates the presence of Kirsten rat sarcoma viral oncogene (KRAS) mutation of glycine to cysteine at codon 12 (G12C) mutations

• Has documented disease progression after receiving 1-2 prior lines of programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy and platinum-based chemotherapy

• Provides archival tumor tissue sample of a tumor lesion not previously irradiated

• Has provided tissue prior to treatment allocation/randomization from a newly obtained biopsy of a tumor lesion not previously irradiated

• Participants with human immunodeficiency virus (HIV) infection must have well-controlled HIV on antiretroviral therapy (ART) per protocol

Locations
United States
Florida
Clermont Oncology Center ( Site 0041)
RECRUITING
Clermont
Other Locations
Israel
Shaare Zedek Medical Center ( Site 0186)
RECRUITING
Jerusalem
Sheba Medical Center ( Site 0180)
RECRUITING
Ramat Gan
Republic of Korea
Severance Hospital, Yonsei University Health System ( Site 0080)
RECRUITING
Seoul
Contact Information
Primary
Toll Free Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2026-04-30
Estimated Completion Date: 2037-05-06
Participants
Target number of participants: 190
Treatments
Experimental: MK-1084 + Patritumab deruxtecan (HER3-DXd)
Participants will receive MK-1084 and HER3-DXd until discontinuation due to toxicity, adverse event (AE) or at the discretion of an investigator.
Experimental: MK-1084 + Sacituzumab tirumotecan (Sac-TMT)
Participants will receive MK-1084 and sac-TMT until discontinuation due to toxicity, AE or at the discretion of an investigator.
Experimental: MK-1084 + Cetuximab
Participants will receive MK-1084 and cetuximab until discontinuation due to toxicity, AE or at the discretion of an investigator.
Sponsors
Collaborators: Daiichi Sankyo
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov

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