CTRI/2025/12/099413尚未招募3 期
A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan in Combination with Pembrolizumab Versus Platinum-based Chemotherapy in Combination with Pembrolizumab, as First-line Therapy in Participants with Locally Advanced Unresectable or Metastatic HER2 overexpressing and PD-L1 TPS 50% Non-squamous Non-small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 686
- 试验地点
- 7
- 主要终点
- Progression Free Survival by Blinded Independent Central Review
研究概览
简要总结
This clinical trial is designed to assess the efficacy and safety of trastuzumab deruxtecan (T-DXd; Enhertu®) in combination with pembrolizumab versus platinum-based chemotherapy in combination with pembrolizumab in participants with no prior therapy for locally advanced unresectable or metastatic non-squamous NSCLC, whose tumors have HER2-overexpressing and PD-L1 TPS <50% without known AGA that have locally available therapies targeting their AGAs in first-line advanced/metastatic setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Sign and date the Tissue Screening ICF, prior to any Tissue Screening procedure.
- •Sign and date the Main ICF, prior to the start of any trialspecific qualification procedures.
- •Sign and date the Optional PGx ICF (included in the Main Screening ICF) prior to any PGx procedure, and the Pregnant Partner ICF, if applicable.
- •Adults 18 years of age on the day of signing the ICF.
- •Follow local regulatory requirements if the legal age of consent for trial participation is 18 years old.
- •Histologically documented non-squamous locally advanced unresectable or metastatic NSCLC and meets all of the following criteria: Has Stage IV NSCLC disease or Stage IIIB or IIIC disease but is not a candidate for surgical resection or definitive chemoradiation at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition).
- •Has no known AGAs (based on existing test result of local test) that have locally available therapies targeting their AGAs in the first-line advanced/metastatic setting.
- •Has no known HER2 mutation based on existing test results (if approved or validated local test is available).
- •Note: Participants with mixed histology are eligible if adenocarcinoma is the predominant histology.
- •Mixed tumors will be classified based on the predominant cell type.
- •Participants who received adjuvant or neoadjuvant therapy other than those listed below, including ICI (ie, anti-PD-1/PD-L1) or a platinum-based regimen, are eligible if the last dose of adjuvant/neoadjuvant therapy was given at least 6 months before the date of the first trial dose and should not have progressed on or within 6 months of the last dose date of adjuvant/neoadjuvant therapy.
- •Any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I.
- •HER2-targeted antibody-based anticancer therapy.
- •Has adequate tumor tissue sample (not previously irradiated) available for assessment of HER2 and PD-L1 expression by central or Sponsor specified laboratory.
- •Details pertaining to tumor tissue submission can be found in the Trial Laboratory Manual.
排除标准
- •Has a medical history of MI within 6 months before randomization/enrollment or symptomatic CHF (NYHA Class II to Class IV).
- •Participants with troponin levels above the ULN at Screening (as defined by the manufacturer) and without any MI-related symptoms should have a cardiologic consultation during the Screening Period to rule out MI.
- •Has a QTc prolongation to 480 ms based on the average of the Screening triplicate 12- lead ECG.
- •Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
- •Has lung-specific, intercurrent, clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial randomization, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc.).
- •Had a prior complete pneumonectomy.
结局指标
主要结局
Progression Free Survival by Blinded Independent Central Review
时间窗: Radiographic disease assessments will be performed at baseline, then every 6 weeks (±7 days) for the first 54 weeks, and every 9 weeks (±7 days) thereafter until documented radiological progression, death, or study discontinuation
次要结局
- Overall Survival(From date of randomization to the date of death due to any cause, up to 85 months.)
研究者
研究点 (7)
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