2024-515698-85-00招募中3 期
A Randomized, Double-Blind, Phase 3 Trial of Adagrasib plus Pembrolizumab plus Chemotherapy vs. Placebo plus Pembrolizumab plus Chemotherapy in Participants with previously Untreated, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer with KRAS G12C Mutation (KRYSTAL-4)
Bristol-Myers Squibb Services Unlimited Company121 个研究点 分布在 8 个国家目标入组 257 人开始时间: 2025年6月3日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 257
- 试验地点
- 121
- 主要终点
- To compare PFS of adagrasib + pembrolizumab + chemotherapy to placebo + pembrolizumab + chemotherapy.
研究概览
简要总结
The main objective of this study is to assess the potential added benefit when Adagrasib is combined with the current standard of care treatment in patients with untreated advanced lung cancer with a KRAS G12C mutation.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of non-squamous NSCLC.
- •Locally advanced or metastatic disease.
- •Measurable disease via computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria of at least 1 lesion.
- •No prior systemic anti-cancer therapy given for advanced or metastatic disease.
- •Not a candidate for definitive therapy (eg, chemoradiation or complete surgical resection)
- •Participants with brain metastases are eligible for enrollment, including those with untreated brain metastases. Brain metastases must be asymptomatic and not in need of immediate local therapy. Any untreated brain metastases must be ≤ 20 mm in diameter.
排除标准
- •Participants with an active autoimmune or inflammatory disease requiring systemic treatment within 2 years prior to randomization..
- •Uncontrolled or significant cardiovascular conditions within 6 months prior to enrollment.
- •Inadequate bone marrow function.
- •Inadequate liver function.
- •Ongoing treatment with concomitant medication known to cause prolonged QTc interval and that cannot be switched to alternative treatment prior to study entry.
- •Treatment targeting KRAS G12C mutation (eg, sotorasib, adagrasib) in any setting.
- •Certain significant ECG abnormalities.
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration.
- •Evidence of active infection requiring parenteral therapy in the 2 weeks prior to randomization.
结局指标
主要结局
To compare PFS of adagrasib + pembrolizumab + chemotherapy to placebo + pembrolizumab + chemotherapy.
To compare PFS of adagrasib + pembrolizumab + chemotherapy to placebo + pembrolizumab + chemotherapy.
To compare OS of adagrasib + pembrolizumab + chemotherapy to placebo + pembrolizumab + chemotherapy.
To compare OS of adagrasib + pembrolizumab + chemotherapy to placebo + pembrolizumab + chemotherapy.
次要结局
- PFS per RECIST v1.1 according to BICR.
研究者
GSM-CT Representative
Scientific
Bristol-Myers Squibb Services Unlimited Company
研究点 (121)
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