Clareo Health | 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)
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)
Per Protocol Amendment 04, overall survival (OS) was moved to be a secondary outcome measure. Additionally, no new participants will be offered Second Course treatment for pembrolizumab.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Has histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
You may not be if
Provides an archival tumor sample (≤5 years) or newly obtained core, incisional, or excisional biopsy or fine needle aspirate (FNA) of a tumor lesion, not previously irradiated to enable central laboratory testing of kirsten rat sarcoma (KRAS) G12C mutation status, programmed cell death ligand 1 (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
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 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 to non-central nervous system (CNS) disease 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 CNS 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