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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 (24) 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
Illinois
University of Illinois Hospital & Health Sciences System ( Site 0044)
RECRUITING
Chicago
Oregon
Providence Oncology and Hematology Care Clinic - Westside ( Site 0059)
RECRUITING
Portland
Providence Portland Medical Center ( Site 0043)
RECRUITING
Portland
Other Locations
Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0282)
RECRUITING
Barretos
Hospital São Lucas da PUCRS ( Site 0283)
RECRUITING
Porto Alegre
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0286)
RECRUITING
São José Do Rio Preto
Hospital Paulistano ( Site 0280)
RECRUITING
São Paulo
Chile
Bradfordhill ( Site 0160)
RECRUITING
Santiago
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0162)
RECRUITING
Santiago
FALP ( Site 0161)
RECRUITING
Santiago
China
Guangdong Provincial People s Hospital ( Site 0300)
RECRUITING
Guangzhou
Greece
Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 0205)
RECRUITING
Athens
THORACIC GENERAL HOSPITAL OF ATHENS I SOTIRIA ( Site 0204)
RECRUITING
Athens
Hong Kong Special Administrative Region
Queen Mary Hospital ( Site 0230)
RECRUITING
Hong Kong
Hong Kong United Oncology Centre ( Site 0232)
RECRUITING
Jordan
Prince of Wales Hospital ( Site 0231)
RECRUITING
Shatin
Israel
Shaare Zedek Medical Center ( Site 0186)
RECRUITING
Jerusalem
Sheba Medical Center ( Site 0180)
RECRUITING
Ramat Gan
Italy
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori ( Site 0176)
RECRUITING
Meldola
Republic of Korea
Severance Hospital, Yonsei University Health System ( Site 0080)
RECRUITING
Seoul
Spain
Hospital Clinic de Barcelona ( Site 0092)
RECRUITING
Barcelona
Institut Català d'Oncologia - L'Hospitalet ( Site 0090)
RECRUITING
Hospitalet
Hospital Universitario Virgen Macarena ( Site 0093)
RECRUITING
Seville
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: 2032-04-13
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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