Status:
RECRUITING
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)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a study evaluating the efficacy and safety of calderasib with pembrolizumab as first-line treatment in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with ...
Eligibility Criteria
Inclusion
- The main inclusion and exclusion criteria include but are not limited to the following:
- Has histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
- Has newly diagnosed Stage IIIB/IIIC NSCLC, not eligible for curative resection or curative chemotherapy/radiation as determined by a multidisciplinary tumor board and/or by radiation oncologist, surgeon, and medical oncologist or Stage IV (M1a, M1b, or M1c) by American Joint Committee on Cancer (AJCC) Staging Manual, Version 8
- Provides an archival tumor tissue sample (≤5 years) or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated to enable central laboratory testing of kirsten rat sarcoma (KRAS) G12C mutation status, PD-L1 status, and biomarker research
- If have had adverse events (AEs) due to previous anticancer therapies, must have recovered to \< Grade 1 or baseline
- If human immunodeficiency virus (HIV)-infected, must have well controlled HIV on antiretroviral therapy (ART)
- If Hepatitis B surface antigen (HBsAg) positive, have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
- If a participant has a history of Hepatitis C virus (HCV) infection, HCV viral load is undetectable
Exclusion
- Has diagnosis of small cell lung cancer. For mixed tumors, if small cell elements are present, the participant is ineligible
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease
- Has known history of, or active, neurologic paraneoplastic syndrome
- Has an active infection requiring systemic therapy, with exceptions
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Has one or more of the following ophthalmological findings/conditions: intraocular pressure \>21 mmHg and/or any diagnosis of glaucoma, diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion, diagnosis of retinal degenerative disease
- Has received prior systemic anticancer therapy for their locally advanced or metastatic NSCLC
- Has received radiation therapy to the lung that is \>30 Gray within 6 months of start of study intervention
- Has received radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not required corticosteroids, and not have had radiation pneumonitis
- Has known active central nervous system metastases and/or carcinomatous meningitis
- Known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has active autoimmune disease that has required systemic treatment in the past 2 years
- Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Is HIV-infected and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has history of allogenic tissue/solid organ transplant
- Has not fully recovered from any effects of major surgical procedure
Key Trial Info
Start Date :
May 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 18 2031
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06345729
Start Date
May 24 2024
End Date
February 18 2031
Last Update
March 6 2026
Active Locations (209)
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1
CBCC Global Research, Inc. ( Site 0123)
Bakersfield, California, United States, 93309
2
Beverly Hills Cancer Center ( Site 0116)
Beverly Hills, California, United States, 90211
3
Stamford Hospital ( Site 0136)
Stamford, Connecticut, United States, 06902
4
Mount Sinai Cancer Center ( Site 0137)
Miami Beach, Florida, United States, 33140