Actively Recruiting
A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F)
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-14
190
Participants Needed
12
Research Sites
574 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 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
CONDITIONS
Official 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
- Tissue from a new biopsy of a tumor lesion not previously irradiated before treatment allocation
- Participants with HIV must have well-controlled infection on antiretroviral therapy
You will not qualify if you...
- Diagnosis of small cell lung cancer or mixed tumors with small cell elements
- Severe pulmonary problems from other lung illnesses
- 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
- Certain severe eye conditions including corneal disease, severe dry eye syndrome, Meibomian gland disease, or blepharitis
- HIV-infected participants with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Previous treatment with KRAS-targeting agents
- Live or live-attenuated vaccine within 30 days before first study dose
- Immunodeficiency or use of chronic systemic steroids or other immunosuppressive therapy within 7 days before first study dose
- Other progressing malignancy requiring treatment within past 3 years
- History or current pneumonitis or interstitial lung disease requiring steroids
- Active infection needing systemic therapy
- Not fully recovered from major surgery or ongoing surgical complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Clermont Oncology Center ( Site 0041)
Clermont, Florida, United States, 34711
Actively Recruiting
2
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0282)
Barretos, São Paulo, Brazil, 14784-400
Actively Recruiting
3
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
4
Hospital Paulistano ( Site 0280)
São Paulo, São Paulo, Brazil, 01321001
Actively Recruiting
5
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0162)
Santiago, Region M. de Santiago, Chile, 7500653
Actively Recruiting
6
Bradfordhill ( Site 0160)
Santiago, Region M. de Santiago, Chile, 8420383
Actively Recruiting
7
Guangdong Provincial People s Hospital ( Site 0300)
Guangzhou, Guangdong, China, 510120
Actively Recruiting
8
Shaare Zedek Medical Center ( Site 0186)
Jerusalem, Israel, 9103102
Actively Recruiting
9
Sheba Medical Center ( Site 0180)
Ramat Gan, Israel, 5265601
Actively Recruiting
10
Severance Hospital, Yonsei University Health System ( Site 0080)
Seoul, South Korea, 03722
Actively Recruiting
11
Hospital Clínic de Barcelona ( Site 0092)
Barcelona, Spain, 08036
Actively Recruiting
12
Hospital Universitario Virgen Macarena ( Site 0093)
Seville, Spain, 41009
Actively Recruiting
Research Team
T
Toll Free Toll Free Number
CONTACT
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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