NCT07554339招募中3 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 310
- 试验地点
- 74
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
Researchers are looking for new ways to treat locally advanced non-small cell lung cancer (NSCLC) that is unresected and has a gene mutation called KRAS G12C. Researchers want to learn if calderasib (MK-1084) can be given with durvalumab, an immunotherapy, to treat NSCLC after chemotherapy and radiation therapy.
The goal of this trial is to learn if participants who receive calderasib and durvalumab live longer without the cancer growing or spreading compared to participants who receive placebo and durvalumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •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.
研究组 & 干预措施
Placebo + Durvalumab
Active Comparator
Participants will receive placebo to calderasib and durvalumab.
干预措施: Placebo to MK-1084 (Other)
Calderasib + Durvalumab
Experimental
Participants will receive calderasib and durvalumab.
干预措施: Durvalumab (Biological)
Placebo + Durvalumab
Active Comparator
Participants will receive placebo to calderasib and durvalumab.
干预措施: Durvalumab (Biological)
Calderasib + Durvalumab
Experimental
Participants will receive calderasib and durvalumab.
干预措施: Calderasib (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Up to approximately 6 years
PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
次要结局
- Overall Survival (OS)(Up to approximately 9 years)
- Number of Participants Who Experience an Adverse Events (AEs)(Up to approximately 9 years)
- Number of Participants Who Discontinue Study Treatment Due to an AE(Up to approximately 9 years)
- Objective Response Rate (ORR)(Up to approximately 9 years)
- Duration of Response (DOR)(Up to approximately 9 years)
- Distant Metastasis-Free Survival (DMFS)(Up to approximately 9 years)
- Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) (Items 29 & 30) Combined Score(Baseline and up to approximately 9 years)
- Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score(Baseline and up to approximately 9 years)
- Change from Baseline in Role Functioning (EORTC QLQ-C30 Items 6 & 7) Combined Score(Baseline and up to approximately 9 years)
研究者
研究点 (74)
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