EUCTR2021-004606-21-GR进行中（未招募）1 期
A Phase III, Randomised, Open-label, Multicentre, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab and Carboplatin Versus Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic NSCLC Without Actionable Genomic Alterations (D926NC00001; AVANZAR) - AVANZAR
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Participants = 18 years at screening
- •Participants with stage IIIB or IIIC, histologically or cytologically documented NSCLC, not amenable for surgical resection or definitive chemoradiation, who have not received prior chemotherapy or other systemic therapy for first-line Stage IIIB, IIIC or IV NSCLC. Progression > 6 months after the last treatment is required for participants who have received prior anticancer treatment for early stage NSCLC.
- •Lacks sensitising EGFR tumour tissue mutation and ALK and ROS1 rearrangements and has no documented tumour genomic alterations in NTRK, BRAF, RET, MET or other actionable driver oncogenes with approved and available therapies (actionable genomic alterations). Testing is not required for tumors with squamous histology, with exceptions.
- •ECOG PS of 0 or 1
- •Archival tumour tissue
- •Has adequate bone marrow reserve and organ function within 7 days before randomisation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 576
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 704
排除标准
- •Mixed small-cell lung cancer and NSCLC histology; sarcomatoid variant of NSCLC
- •History of another primary malignancy with exceptions
- •Persistent toxicities caused by previous anti-cancer therapy not yet improved to Grade = 1 or baseline, with exceptions
- •Spinal cord compression or clinically or radiologically active brain metastases
- •History of leptomeningeal carcinomatosis.
- •Known active or uncontrolled hepatitis B or C virus infection.
- •Uncontrolled or suspected infection requiring IV antibiotics, antivirals, or antifungals
- •Clinically significant corneal disease
- •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
研究者
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