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RecruitingInterventionalPhase 3

A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)

NCT ID: NCT07190248Sponsor: Merck Sharp & Dohme LLCLast updated: 2026-06-12

Summary

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.

Arms & interventions

  • DrugCalderasib

    Administered as an oral tablet

  • BiologicalPembrolizumab (+) Berahyaluronidase alfa

    Administered as a SC injection

  • DrugPemetrexed

    Administered as an IV Infusion

  • DrugCisplatin

    Administered as an IV Infusion

  • DrugCarboplatin

    Administered as an IV Infusion

Outcome measures

Primary

  • Progression Free Survival (PFS) in Participants with Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%

    PFS is defined as the time from randomization until either documented disease progression per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. PFS as determined by blinded independent central review (BICR) will be presented.

    Time frame: Up to approximately 48 months

Secondary

  • PFS in All Participants

    Time frame: Up to approximately 48 months

  • Overall Survival (OS) in Participants with PD-L1 TPS ≥1%

    Time frame: Up to approximately 62 months

  • OS in Participants in All Participants

    Time frame: Up to approximately 62 months

  • Overall Response Rate (ORR) in All Participants

    Time frame: Up to approximately 48 months

  • ORR in Participants with PD-L1 TPS ≥1%

    Time frame: Up to approximately 48 months

  • Duration of Response (DOR)

    Time frame: Up to approximately 48 months

  • Number of Participants Who Experienced One or More Adverse Events (AEs)

    Time frame: Up to approximately 81 months

  • Number of Participants Who Discontinued Study Treatment Due to an AE

    Time frame: Up to approximately 81 months

  • Change from Baseline in Global Health Status/Quality of Life (GHS/QoL) (Items 29, 30) on the European Organization for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30)

    Time frame: Baseline and up to approximately 81 months

  • Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30

    Time frame: Baseline and up to approximately 81 months

  • Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire (EORTC QLQ-LC13)

    Time frame: Baseline and up to approximately 81 months

  • Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13

    Time frame: Baseline and up to approximately 81 months

  • Time to Deterioration (TTD) in GHS/QoL (Items 29, 30) on the EORTC QLQ-C30

    Time frame: Baseline and up to approximately 81 months

  • TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30

    Time frame: Baseline and up to approximately 81 months

  • TTD in Cough Score (Item 31) on the EORTC QLQ-LC13

    Time frame: Baseline and up to approximately 81 months

  • TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13

    Time frame: Baseline and up to approximately 81 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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 locations (9)

Central Alabama Research ( Site 0108)

Birmingham, Alabama, 35209

Recruiting
Study Coordinator · Contact
205-949-1907

Stamford Hospital ( Site 0126)

Stamford, Connecticut, 06902

Recruiting
Study Coordinator · Contact
203-276-2695

Mount Sinai Cancer Center ( Site 0137)

Miami Beach, Florida, 33140

Completed

Indiana University Health Arnett Cancer Center ( Site 0116)

Lafayette, Indiana, 47904

Recruiting
Study Coordinator · Contact
765-838-6885

New England Cancer Specialists ( Site 0139)

Westbrook, Maine, 04092

Recruiting
Study Coordinator · Contact
207-303-3300

New York Oncology Hematology, P.C. ( Site 0119)

Albany, New York, 12206

Recruiting
Study Coordinator · Contact
518-489-3612

St. Charles Health System, Inc ( Site 0146)

Bend, Oregon, 97701

Recruiting
Study Coordinator · Contact
541-706-5800

Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0111)

Lancaster, Pennsylvania, 17601

Recruiting
Study Coordinator · Contact
717-544-9400

Blue Ridge Cancer Care ( Site 0144)

Roanoke, Virginia, 24014

Recruiting
Study Coordinator · Contact
540-982-0237
A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007) | Cancerify