A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07190248
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Calderasib — DRUG
    Administered as an oral tablet
  • Pembrolizumab (+) Berahyaluronidase alfa — BIOLOGICAL
    Administered as a SC injection
  • Pemetrexed — DRUG
    Administered as an IV Infusion
  • Cisplatin — DRUG
    Administered as an IV Infusion
  • Carboplatin — DRUG
    Administered as an IV Infusion

Study Details

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.

Key Dates

Start date
Oct 8, 2025
Status verified
Jun 2026
Primary completion
Dec 7, 2029
Completion
Aug 6, 2032

Study Design

Enrollment
675 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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).

Primary Outcome Measure

Progression Free Survival (PFS) in Participants with Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% [ Time Frame: Up to approximately 48 months ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Central Alabama Research ( Site 0108)BirminghamAlabama35209
Study Coordinator
205-949-1907
Stamford Hospital ( Site 0126)StamfordConnecticut06902
Study Coordinator
203-276-2695
Mount Sinai Cancer Center ( Site 0137)Miami BeachFlorida33140-
Indiana University Health Arnett Cancer Center ( Site 0116)LafayetteIndiana47904
Study Coordinator
765-838-6885
New England Cancer Specialists ( Site 0139)WestbrookMaine04092
Study Coordinator
207-303-3300
New York Oncology Hematology, P.C. ( Site 0119)AlbanyNew York12206
Study Coordinator
518-489-3612
St. Charles Health System, Inc ( Site 0146)BendOregon97701
Study Coordinator
541-706-5800
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0111)LancasterPennsylvania17601
Study Coordinator
717-544-9400
Blue Ridge Cancer Care ( Site 0144)RoanokeVirginia24014
Study Coordinator
540-982-0237

Find similar trials in Birmingham, AL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Central Alabama Research· Birmingham, ALStamford Hospital· Stamford, CTMount Sinai Cancer Center· Miami Beach, FLIndiana University Health Arnett Cancer Center· Lafayette, INNew England Cancer Specialists· Westbrook, MENew York Oncology Hematology, P.C.· Albany, NY

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