A Phase 3, Multicenter, Double-Blind, Placebo-controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination With Standard of Care Immunotherapy in Participants With Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer - SUNRAY-02
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 374
- 主要终点
- Part A: Disease-Free Survival (DFS) by Investigator Assessment
研究概览
简要总结
The main purpose of this study is to assess if olomorasib in combination with pembrolizumab is more effective than the pembrolizumab and placebo combination in part A in participants with resected KRAS G12C-mutant NSCLC and to assess if olomorasib in combination with durvalumab is more effective than the durvalumab and placebo combination in part B in participants with unresectable KRAS G12C-mutant non-small cell lung cancer. The study may last up to 3 years for each participant.
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
- Double (Participant, Investigator)
盲法说明
Both Part A and B are randomized, double-blind, placebo-controlled.
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
- •Histological or cytological confirmation of NSCLC.
- •Clinical Stage II-IIIB (N0, N1, N2) treated with presurgical chemoimmunotherapy, with residual tumor present at time of surgery. Patients with a pathologic complete response are not eligible.
- •Pathologic Stage II-IIIB (N0, N1, N2) NSCLC treated with initial upfront resection.
- •Part B - Clinical Stage III, unresectable NSCLC, without progression on concurrent platinum-based chemoradiotherapy.
- •Must have disease with evidence of KRAS G12C mutation.
- •Must have known programmed death-ligand 1 (PD-L1) expression
- •Must have an ECOG performance status of 0 or
- •Able to swallow oral medication.
- •Must have adequate laboratory parameters.
- •Contraceptive use should be consistent with local regulations for those participating in clinical studies.
- •Women of childbearing potential must
- •Have a negative pregnancy test.
- •Not be breastfeeding during treatment
排除标准
- •Have known, actionable changes in the EGFR or ALK genes.
- •Have another type of cancer that is progressing or required active treatment within the past 2 years before screening.
- •Have an active autoimmune disease that required systemic treatment in the past 2 years. Endocrine replacement therapy is allowed.
- •Had any immune-related side effect or allergic reaction (Grade 3 or higher) from a previous immunotherapy medicine, or any immune-related side effect greater than Grade 1 that has not resolved. This does not apply for people with hormone-related diseases who are now on stable hormone replacement therapy.
研究组 & 干预措施
Part B: Placebo + Durvalumab
Participants will receive placebo administered orally in combination with durvalumab administered IV for up to 1 year followed by placebo alone for up to 3 years of total treatment.
干预措施: Durvalumab (Drug)
Part B: Olomorasib + Durvalumab
Participants will receive olomorasib administered orally in combination with durvalumab administered IV for up to 1 year followed by olomorasib alone for up to 3 years of total treatment.
干预措施: Durvalumab (Drug)
Part A: Olomorasib + Pembrolizumab
Participants will receive olomorasib administered orally in combination with pembrolizumab intravenously (IV) for up to 1 year followed by olomorasib alone for up to 3 years of total treatment.
干预措施: Olomorasib (Drug)
Part A: Placebo + Pembrolizumab
Participants will receive placebo administered orally in combination with pembrolizumab administered IV for up to 1 year followed by placebo alone for up to 3 years of total treatment.
干预措施: Pembrolizumab (Drug)
Part A: Placebo + Pembrolizumab
Participants will receive placebo administered orally in combination with pembrolizumab administered IV for up to 1 year followed by placebo alone for up to 3 years of total treatment.
干预措施: Placebo (Drug)
Part B: Placebo + Durvalumab
Participants will receive placebo administered orally in combination with durvalumab administered IV for up to 1 year followed by placebo alone for up to 3 years of total treatment.
干预措施: Placebo (Drug)
Part A: Olomorasib + Pembrolizumab
Participants will receive olomorasib administered orally in combination with pembrolizumab intravenously (IV) for up to 1 year followed by olomorasib alone for up to 3 years of total treatment.
干预措施: Pembrolizumab (Drug)
Part B: Olomorasib + Durvalumab
Participants will receive olomorasib administered orally in combination with durvalumab administered IV for up to 1 year followed by olomorasib alone for up to 3 years of total treatment.
干预措施: Olomorasib (Drug)
结局指标
主要结局
Part A: Disease-Free Survival (DFS) by Investigator Assessment
时间窗: Randomization to disease recurrence or death from any cause (Estimated as approximately 4 years).
DFS by Investigator Assessment
Part B: Progression-Free Survival (PFS) by BICR
时间窗: Randomization to disease progression or death from any cause (Estimated as approximately 3 years).
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR)
次要结局
- Part B: Duration of Response (DOR) per RECIST 1.1 by BICR and Investigator(Randomization to disease progression or death from any cause (Estimated as approximately 3 years).)
- Part B: Disease Control Rate (DCR) per RECIST 1.1 by BICR and Investigator(Randomization to disease progression or death from any cause (Estimated as approximately 3 years).)
- Part B: Time to Response (TTR) per RECIST 1.1 by BICR and Investigator(Randomization until the date that measurement criteria for CR or PR (whichever is first recorded) are first met (Estimated as approximately 3 years).)
- Part B: PFS by Investigator(Randomization to disease progression or death from any cause (Estimated as approximately 3 years))
- Part B: Objective Response Rate (ORR) per RECIST 1.1 by BICR and Investigator(Randomization to disease progression or death from any cause (Estimated as approximately 3 years).)
- Part A & B: Overall Survival (OS)(Randomization to disease progression or death from any cause (Estimated as approximately 5 years).)
- Part A & B: Change from baseline in health-related quality of life (HRQoL), measured by European Organization for Research & Treatment of CancerQualityofLifeQuestionnaire-Core 30 (EORTC QLQ-C30)(Randomization through end of treatment (Estimated as approximately 3 years).)
- Part B: Progression-Free Survival 2 (PFS2) by investigator assessment(Randomization to disease progression on next line of treatment or death from any cause (Estimated as approximately 3 years).])
- Part B: Changes in Non-Small Cell Lung Cancer (NSCLC)-related symptoms, measured by the NSCLC-Symptom Assessment Questionnaire (SAQ)(Randomization through end of treatment (Estimated as approximately 3 years).)
- Part B: Time to worsening of NSCLC-related symptoms, as measured by NSCLC-SAQ(Randomization through end of treatment (Estimated as approximately 3 years).)
- Part B: Changes in patient-reported pulmonary symptoms of cough, chest pain, and dyspnea, measured by NSCLC-SAQ(Randomization through end of treatment (Estimated as approximately 3 years).)