A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015)

Ki vehet részt

• The main inclusion criteria include but are not limited to the following:
• Has a histological or cytological diagnosis of locally advanced, unresected Stage II (node-positive) to III non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology
• Has completed definitive platinum-based concurrent chemoradiotherapy (CCRT) prior to enrollment, without disease progression
• Has provided a tumor tissue sample for central laboratory testing of Kirsten rat sarcoma G12C (KRAS G12C) status, programmed cell death ligand 1 (PD-L1) status, and biomarker research
• Tumor tissue sample has a demonstrated presence of KRAS G12C mutation and an evaluable PD-L1 status result
• If human immunodeficiency virus (HIV)-infected, has well-controlled HIV on antiretroviral therapy (ART)
• If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy
• If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load
• Has a body weight ≥35 kg

Ki nem vehet részt

• Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease
• Has received prior treatment (other than definitive CCRT) for NSCLC
• Has not adequately recovered from major surgery or has ongoing surgical complications
• Has a diagnosis of small cell lung cancer or mixed tumors with small cell elements
• Has a gastrointestinal disorder affecting absorption or is unable to swallow orally administered medication
• Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
• Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
• Has an active autoimmune disease that has required systemic treatment in the past 2 years
• Has a history of, or has current, (noninfectious) pneumonitis/interstitial lung disease that required/requires steroids
• Has an active infection requiring systemic therapy
• Has a history of stem cell/solid organ transplant
• The main exclusion criteria include but are not limited to the following: