A Clinical Study of Calderasib (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 calderasib and subcutaneous (SC) pembrolizumab can be used to treat non-small cell lung cancer (NSCLC) when given together. Calderasib is a targeted therapy for the KRAS G12C mutation. The goal of this study is to learn if people who receive calderasib 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 Calderasib + 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 calderasib 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
Birmingham, Alabama 35209
Study Coordinator
205-949-1907
Stamford, Connecticut 06902
Study Coordinator
203-276-2695
Miami Beach, Florida 33140
Study Coordinator
305-674-2625
Westbrook, Maine 04092
Study Coordinator
207-303-3300
Albany, New York 12206
Study Coordinator
518-489-3612
Lancaster, Pennsylvania 17601
Study Coordinator
717-544-9400
Roanoke, Virginia 24014
Study Coordinator
540-982-0237
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC