A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator Controlled Study of MK-1084 Plus Durvalumab Versus Placebo Plus Durvalumab in Participants With Locally Advanced, Unresected KRAS G12C-Mutant Non-Small Cell Lung Cancer Without Disease Progression Following Definitive Platinum-Based Chemoradiotherapy (KANDLELIT-015)

未提供0 个研究点目标入组 27 人开始时间: 待定

适应症

试验速览

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•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.

•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 active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease.
•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 received prior treatment (other than definitive CCRT) for NSCLC.
•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.
•Has not adequately recovered from major surgery or has ongoing surgical complications.

发起方

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