A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F)
Purpose
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
Condition
- Lung Neoplasm Malignant
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
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
Exclusion Criteria
The main exclusion criteria include but are not limited to the following: - Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements - Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis - Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease - Has evidence of any leptomeningeal disease - Has uncontrolled or significant cardiovascular disorder or cerebrovascular disease prior to allocation/randomization - Has one or more of the following ophthalmological conditions: a) Clinically significant corneal disease b) history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis - HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease - Has received previous treatment with an agent targeting KRAS - Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention - Has known additional malignancy that is progressing or has required active treatment within the past 3 years - Has history of (noninfectious) pneumonitis/ interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD - Has an active infection requiring systemic therapy - Have not adequately recovered from major surgery or have ongoing surgical complications
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- Participants will be enrolled and treated sequentially during dose escalation followed by parallel assignment in the expansion phase.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Clermont, Florida 34711
Study Coordinator
386-538-3169
Chicago, Illinois 60612
Study Coordinator
312-996-9272
Portland, Oregon 97213
Study Coordinator
503-215-1979
Portland, Oregon 97225
Study Coordinator
503-215-1979
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC
Detailed Description
This is a substudy of the master protocol MK-3475-U01 (KEYMAKER-U01) - NCT04165798.