A Clinical Study of MK-1084 and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)
Purpose
Researchers want to learn if the study medicines MK-1084 and subcutaneous (SC) pembrolizumab can be used to treat non-small cell lung cancer (NSCLC) when given together. MK-1084 is a targeted therapy for the KRAS G12C mutation. The goal of this study is to learn if people who receive MK-1084 with SC pembrolizumab live longer without the cancer growing or spreading than in people who receive SC pembrolizumab with chemotherapy.
Condition
- Non-small Cell Lung Cancer
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 nonsquamous NSCLC (Stage IIIB, Stage IIIC) not eligible for curative resection or chemoradiation or Stage IV: M1a, M1b, or M1c - If human immunodeficiency virus (HIV) positive, must have well controlled HIV on antiretroviral therapy (ART)
Exclusion Criteria
The main exclusion criteria include but are not limited to the following: - Has diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements - Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea) - Has uncontrolled, significant cardiovascular disease or cerebrovascular disease - Has a gastrointestinal disorder affecting absorption - Is HIV positive and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease - Has received prior systemic anticancer therapy for their advanced or metastatic NSCLC - Has known additional malignancy that is progressing or has required active treatment within the past 3 years - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis - Has active autoimmune disease that has required systemic treatment in the past 2 years - History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease - Has active infection requiring systemic therapy except those specified by protocol - Has history of stem cell/solid organ transplant - Has not adequately recovered from major surgery or has ongoing surgical complications
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental MK-1084 + Pembrolizumab (+) Berahyaluronidase alfa |
Participants will receive pembrolizumab (+) berahyaluronidase alfa at a fixed dose subcutaneously on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) plus MK-1084 until discontinuation criterion is met. |
|
|
Active Comparator Pembrolizumab (+) Berahyaluronidase alfa + Chemotherapy |
Participants will receive pembrolizumab (+) berahyaluronidase alfa at a fixed dose subcutaneously on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) and pemetrexed via intravenous (IV) infusion at a dose of 500 mg/m^2 on days 1 and 22 of cycles 1 and 3 until discontinuation criterion is met PLUS investigator's choice of carboplatin via IV infusion at area under curve (AUC) 5 mg/mL/minute on days 1 and 22 of cycles 1 and 3 (up to 4 doses, approximately 6 weeks) OR cisplatin via IV infusion at a dose of 75 mg/m^2 on days 1 and 22 of cycles 1 and 3 (up to 4 doses, approximately 6 weeks). |
|
Recruiting Locations
Miami Beach 4164143, Florida 4155751 33140
Study Coordinator
305-674-2625
Westbrook 4982753, Maine 4971068 04092
Study Coordinator
207-303-3300
Albany 5106834, New York 5128638 12206
Study Coordinator
518-489-3612
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC