Actively Recruiting
A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic NSCLC With PD-L1 TPS 50 KANDLELIT-004
Led by Merck Sharp & Dohme LLC · Updated on 2026-06-08
600
Participants Needed
225
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of calderasib and pembrolizumab as a first-line treatment for people with locally advanced or metastatic non-small cell lung cancer NSCLC that has a specific KRAS G12C mutation and a PD-L1 tumor proportion score of 50 or higher. This Phase 3 study aims to compare this combination against pembrolizumab with a placebo to see if it improves progression-free survival and overall survival. Participants are randomly assigned to receive pembrolizumab 200 mg via intravenous infusion every 21 days for up to 35 cycles, combined either with oral calderasib tablets or with a placebo taken daily until the treatment needs to be stopped. The study is double-blind, meaning neither the participants nor the researchers know which treatment is given, to ensure unbiased results. During the study, participants will be closely monitored with regular assessments to track cancer progression, survival, response to treatment, and quality of life using specialized questionnaires. Safety will be evaluated by recording any adverse events and treatment discontinuations. The main outcomes will be observed for up to approximately 42 months for progression-free survival and up to 56 months for overall survival, with quality of life assessments continuing for about 24 months.
CONDITIONS
Brief Title
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
- Newly diagnosed Stage IIIB/IIIC NSCLC not eligible for curative surgery or chemotherapy/radiation, or Stage IV by AJCC Staging Manual Version 8
- Provide archival tumor tissue (up to 5 years old) or newly obtained biopsy for KRAS G12C mutation and PD-L1 testing
- Recovery to less than Grade 1 or baseline from any prior anticancer therapy adverse events
- Well controlled HIV on antiretroviral therapy if infected
- If Hepatitis B surface antigen positive, must have received antiviral therapy for at least 4 weeks with undetectable viral load
- Undetectable Hepatitis C viral load if history of infection
You will not qualify if you...
- Diagnosis of small cell lung cancer or presence of small cell elements in mixed tumors
- Active inflammatory bowel disease requiring immunosuppressive medication or history of such disease
- Known or active neurologic paraneoplastic syndrome
- Active infection requiring systemic therapy (with some exceptions)
- Uncontrolled, significant cardiovascular or cerebrovascular disease
- Certain eye conditions including glaucoma, central serous retinopathy, retinal vein or artery occlusion, or retinal degenerative disease
- Prior systemic anticancer therapy for locally advanced or metastatic NSCLC
- Radiation therapy to lung exceeding 30 Gray within 6 months before study
- Radiotherapy within 2 weeks before study without full recovery from toxicities
- Active central nervous system metastases or carcinomatous meningitis
- Another progressing malignancy requiring treatment within past 3 years
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis/interstitial lung disease requiring steroids
- HIV infection with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- History of allogenic tissue or solid organ transplant
- Not fully recovered from effects of major surgery
Research Team
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