Actively Recruiting
KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Study of MK-1084 With Other Treatments for Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer With KRAS G12C Mutations
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-26
190
Participants Needed
18
Research Sites
299 weeks
Total Duration
On this page
Sponsors
M
Merck Sharp & Dohme LLC
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the targeted therapy MK-1084 to see if it can treat advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has KRAS G12C mutations. This research aims to learn about the safety and tolerance of MK-1084 when combined with other treatments, as well as how many people experience tumor shrinkage or disappearance. The trial is part of a larger master protocol and includes participants who have previously received certain lung cancer therapies. Participants are randomly assigned to receive MK-1084 along with one of three other drugs: patritumab deruxtecan (HER3-DXd), sacituzumab tirumotecan (Sac-TMT), or cetuximab. MK-1084 is taken by mouth, while the other drugs are given by intravenous infusion. Treatment continues until side effects or adverse events require stopping, or at the investigator's discretion. Rescue medications are available to help manage side effects related to chemotherapy. During the study, participants will be closely monitored for side effects and treatment tolerance up to approximately 65 months. Researchers will measure how many participants experience dose-limiting toxicities, adverse events, and treatment discontinuations due to side effects. They will also assess the cancer response rate, duration of response, and progression-free survival over time. The total follow-up for progression-free survival may last up to about 124 months, ensuring long-term observation of the treatment effects.
CONDITIONS
Brief Title
A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed advanced or metastatic non-squamous non-small cell lung cancer (NSCLC)
- Tumor tissue or circulating tumor DNA showing KRAS G12C mutation
- Disease progression after 1-2 prior lines of PD-1/PD-L1 therapy and platinum-based chemotherapy
- Archival tumor tissue sample from a lesion not previously irradiated
- Newly obtained biopsy tissue from a lesion not previously irradiated prior to treatment assignment
- Well-controlled HIV infection on antiretroviral therapy (ART) if applicable
You will not qualify if you...
- Diagnosis of small cell lung cancer or presence of small cell elements in mixed tumors
- Clinically severe pulmonary compromise from other lung illnesses
- Known active central nervous system metastases or carcinomatous meningitis
- Active inflammatory bowel disease requiring immunosuppressive medication or history of such disease
- Evidence of leptomeningeal disease
- Uncontrolled or significant cardiovascular or cerebrovascular disease prior to treatment
- Clinically significant corneal disease or severe dry eye syndrome, Meibomian gland disease, or blepharitis
- History of Kaposi's sarcoma or Multicentric Castleman's Disease in HIV-infected participants
- Previous treatment with agents targeting KRAS
- Receipt of live or live-attenuated vaccine within 30 days before study drug
- Diagnosis of immunodeficiency or recent systemic steroid or immunosuppressive therapy within 7 days before study drug
- Known additional malignancy progressing or requiring treatment within past 3 years
- History or current pneumonitis or interstitial lung disease requiring steroids
- Active infection requiring systemic therapy
- Incomplete recovery from major surgery or ongoing surgical complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 65 months
Participants receive MK-1084 combined with one of three biological therapies (Patritumab deruxtecan, Sacituzumab tirumotecan, or Cetuximab) until discontinuation due to toxicity, adverse events, or investigator decision.
Regular visits for treatment administration and monitoring as per protocol
Duration - Up to approximately 124 months
Participants are monitored for safety and disease progression after treatment ends.
Periodic visits for safety and disease assessment
Trial Site Locations
Total: 18 locations
1
Clermont Oncology Center ( Site 0041)
Clermont, Florida, United States, 34711
Actively Recruiting
2
University of Illinois Hospital & Health Sciences System ( Site 0044)
Chicago, Illinois, United States, 60612
Actively Recruiting
3
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0282)
Barretos, São Paulo, Brazil, 14784-400
Actively Recruiting
4
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0286)
São José do Rio Preto, São Paulo, Brazil, 15090-000
Actively Recruiting
5
Hospital Paulistano ( Site 0280)
São Paulo, São Paulo, Brazil, 01321001
Actively Recruiting
6
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0162)
Santiago, Region M. de Santiago, Chile, 7500653
Actively Recruiting
7
FALP ( Site 0161)
Santiago, Region M. de Santiago, Chile, 7500921
Actively Recruiting
8
Bradfordhill ( Site 0160)
Santiago, Region M. de Santiago, Chile, 8420383
Actively Recruiting
9
Guangdong Provincial People s Hospital ( Site 0300)
Guangzhou, Guangdong, China, 510120
Actively Recruiting
10
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 0204)
Athens, Attica, Greece, 115 27
Actively Recruiting
11
Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 0205)
Athens, Attica, Greece, 115 28
Actively Recruiting
12
Queen Mary Hospital ( Site 0230)
Hong Kong, Hong Kong, 000000
Actively Recruiting
13
Shaare Zedek Medical Center ( Site 0186)
Jerusalem, Israel, 9103102
Actively Recruiting
14
Sheba Medical Center ( Site 0180)
Ramat Gan, Israel, 5265601
Actively Recruiting
15
Severance Hospital, Yonsei University Health System ( Site 0080)
Seoul, South Korea, 03722
Actively Recruiting
16
Institut Català d'Oncologia - L'Hospitalet ( Site 0090)
Hospitalet, Barcelona, Spain, 08908
Actively Recruiting
17
Hospital Clinic de Barcelona ( Site 0092)
Barcelona, Spain, 08036
Actively Recruiting
18
Hospital Universitario Virgen Macarena ( Site 0093)
Seville, Spain, 41009
Actively Recruiting
Research Team
T
Toll Free Toll Free Number
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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