NCT04819100进行中（未招募）3 期
LIBRETTO-432: A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib Following Definitive Locoregional Treatment in Participants With Stage IB-IIIA RET Fusion-Positive NSCLC
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 152
- 试验地点
- 419
- 主要终点
- Event-Free Survival (EFS)
研究概览
简要总结
The reason for this study is to see if the study drug, selpercatinib, compared to placebo is effective and safe in delaying cancer return in participants with early-stage non-small cell lung cancer (NSCLC), who have already had surgery or radiation. Participants who are assigned to placebo and stop the study drug because their disease comes back or gets worse have the option to potentially crossover to selpercatinib. Participation could last up to three years.
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
- •Must have histologically confirmed Stage IB, II, or IIIA NSCLC.
- •Must have an activating RET gene fusion in tumor based on polymerase chain reaction (PCR), next generation sequencing (NGS), or another molecular test per sponsor's approval.
- •Must have received definitive locoregional therapy with curative intent (surgery or radiotherapy) for Stage IB, II, or IIIA NSCLC.
- •-- Must have undergone the available anti-cancer therapy (including chemotherapy or durvalumab) or not be suitable for it, based on the investigator's discretion.
- •Maximum time allowed between definitive therapy completion and randomization must be:
- •10 weeks if no chemotherapy was administered
- •26 weeks if adjuvant chemotherapy was administered
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Adequate hematologic, hepatic, and renal function.
- •Willingness of men and women of reproductive potential to observe conventional and highly effective birth control for the duration of the study and for at least 2 weeks after last dose of study drug.
排除标准
- •Additional oncogenic drivers in NSCLC, if known.
- •Evidence of small cell lung cancer.
- •Clinical or radiologic evidence of disease recurrence or progression following definitive therapy.
- •Known or suspected interstitial fibrosis or interstitial lung disease or history of (noninfectious) pneumonitis that required steroids.
- •Clinically significant active cardiovascular disease or history of myocardial infarction within six months prior to planned start of selpercatinib or prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) greater than 470 milliseconds.
- •Have known uncontrolled human immunodeficiency virus (HIV)-1/2 infection.
- •Have known active hepatitis B or C.
- •Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment.
- •Major surgery within 4 weeks prior to planned start of selpercatinib.
- •Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug.
- •Other malignancy unless nonmelanoma skin cancer, carcinoma in situ of the cervix or other in situ cancers or a malignancy diagnosed greater than or equal to two years previously and not currently active.
- •Pregnancy or lactation.
- •Prior treatment with a selective RET inhibitor (e.g. selpercatinib or pralsetinib).
研究组 & 干预措施
Selpercatinib
Experimental
Selpercatinib administered orally.
干预措施: Selpercatinib (Drug)
Placebo
Placebo Comparator
Placebo administered orally.
干预措施: Placebo (Drug)
结局指标
主要结局
Event-Free Survival (EFS)
时间窗: Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)
EFS by Investigator Assessment in the Primary Analysis Population
次要结局
- Overall Survival (OS)(Randomization to death from any cause (estimated as up to 9 years)])
- Mean Change from Baseline over Time in NSCLC Symptoms(Baseline to treatment discontinuation (estimated as up to 3 years))
- Mean Change from Baseline over Time in Physical Function(Baseline to treatment discontinuation (estimated as up to 3 years))
- EFS(Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)])
- Time to Distant Disease Recurrence in the Central Nervous System (CNS)(Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years))
- Positive Predictive Value (PPV) of Rearranged during Transfection (RET) Tests from Investigator-Identified Laboratories with Respect to the Lilly-Designated RET Test(Baseline)
- Progression Free Survival on the Next Line of Treatment (PFS2)(Randomization to disease progression on the next line of treatment or death from any cause (estimated as up to 9 years))
- EFS(Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years))
研究者
研究点 (419)
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