2024-512195-35-00招募中3 期
A Phase III, Randomised, Open-label, Global Study of Adjuvant Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma Non-small Cell Lung Cancer who are ctDNA-positive or Have High-risk Pathological Features (TROPION Lung12)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 119
- 试验地点
- 47
- 主要终点
- Disease-Free Survival (DFS) using BICR in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive or having at least one high-risk pathological feature treated with adjuvant Dato-DXd in combination with rilvegostomig relative to SoC
研究概览
简要总结
To demonstrate superiority of adjuvant Dato-DXd in combination with rilvegostomig relative to SoC by assessment of DFS using BICR, following complete tumour resection, in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive or have at least one high-risk pathological feature.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Post-intervention follow-up period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Histologically documented treatment-naive Stage I (T < 4 cm, AJCC 8th ed) adenocarcinoma NSCLC
- •Complete surgical resection (R0) of the primary NSCLC
- •Unequivocal no evidence of disease at post-surgical baseline scan
- •Pre-surgical ctDNA-positive result (Stage IA or IB) OR presence of at least one high-risk pathological feature (visceral pleural invasion (VPI), lymphovascular invasion (LVI), high-grade histology) (Stage IB only)
- •ECOG of 0 or 1, life expectancy of > 6 months and complete recovery after surgery
- •Adequate bone marrow reserve and organ function
排除标准
- •Sensitizing EGFR mutation and/or ALK alteration
- •History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
- •Significant pulmonary function compromise
- •History of another primary malignancy within 3 years (with exceptions)
- •Any evidence of severe or uncontrolled systemic diseases, including but not limited to bleeding diseases, active infection and cardiac disease
- •Active or prior documented autoimmune or inflammatory disorders (with exceptions)
- •Active infection with tuberculosis, hepatitis A, B or C virus, or known HIV infection that is not well controlled
- •History of active primary immunodeficiency
- •Clinically significant corneal disease
结局指标
主要结局
Disease-Free Survival (DFS) using BICR in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive or having at least one high-risk pathological feature treated with adjuvant Dato-DXd in combination with rilvegostomig relative to SoC
Disease-Free Survival (DFS) using BICR in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive or having at least one high-risk pathological feature treated with adjuvant Dato-DXd in combination with rilvegostomig relative to SoC
次要结局
- OS (Overall Survival): The analysis will include all randomised participants as randomised. All deaths will be included, regardless of whether the participant withdraws from therapy or receives another anti-cancer therapy. The measure of interest is the HR of OS.
- Participant-reported physical function: The analysis will include all randomised participants as randomised. The measure of interest will be the between treatment group difference in adjusted mean in physical function scores at Weeks 12, 24 and 48.
- Participant-reported GHS/QoL: The analysis will include all randomised participants as randomised. The measure of interest will be the between treatment group difference in adjusted mean in GHS/QoL scores at Weeks 12, 24 and 48.
- Pharmacokinetics (PK): Concentration of rilvegostomig, Dato-DXd, total anti‑TROP2 antibody, and MAAA‑1181a (payload deruxtecan) in serum or plasma and PK parameters (peak and trough concentrations).
- Immunogenicity: Presence of ADAs for Dato-DXd and rilvegostomig (confirmatory results: titres and neutralizing antibodies for confirmed positive samples).
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (47)
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