2024-518586-10-00招募中3 期
A Phase 2/3 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination with Osimertinib as First-Line Treatment in Patients with Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 14
- 主要终点
- Phase 2: Objective response (OR) based on Blinded independent central review (BICR) assessment per RECIST version 1.1
研究概览
简要总结
Phase 2: - To evaluate the safety and tolerability of telisotuzumab adizutecan in combination with osimertinib. - To optimize and select the RP3D of telisotuzumab adizutecan in combination with osimertinib. - To evaluate the efficacy as measured by ORR of telisotuzumab adizutecan in combination with osimertinib. Phase 3: To demonstrate the superiority of telisotuzumab adizutecan in combination with osimertinib over standard of care in terms of efficacy measured by PFS based on BICR assessment.
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
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 during the screening period and prior to dosing of study treatment on Cycle 1 Day
- •All participants must consent to provide recently obtained FFPE tumor tissue (ideally collected during or after locally advanced or metastatic diagnosis) or archived tissue during screening for c-Met IHC testing and study stratification. c-Met IHC results are required prior to randomization.
- •Participants must have at least one non-irradiated measurable disease per RECIST version 1.
- •If only one measurable lesion exists, it is acceptable to be used (as a target lesion) as long as it has not been previously irradiated and as long as it has not been biopsied within 14 days of the baseline tumor assessment scans.
- •Any toxicities from prior systemic anti-cancer therapy must have resolved to CTCAE Grade 1 or baseline level (except for alopecia [any grade] or Grade ≤ 2 peripheral neuropathy).
- •Participants should not have any major, life-threatening conditions and life expectancy as determined by the investigator should be at least 3 months.
排除标准
- •History of interstitial lung disease (ILD), pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest CT scan.
- •History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
- •History of any malignancy except for malignancy treated with curative intent and with no known active disease present for 2 years before the first dose of study treatment and felt to be at low risk for recurrence by investigator, successfully treated nonmelanoma skin cancer or localized carcinoma in situ of the cervix.
- •Participants has leptomeningeal disease, or subject has spinal cord compression not definitively treated with surgery or radiation.
结局指标
主要结局
Phase 2: Objective response (OR) based on Blinded independent central review (BICR) assessment per RECIST version 1.1
Phase 2: Objective response (OR) based on Blinded independent central review (BICR) assessment per RECIST version 1.1
Phase 3: Progression-free survival (PFS) based on BICR assessment per RECIST version 1.1.
Phase 3: Progression-free survival (PFS) based on BICR assessment per RECIST version 1.1.
次要结局
- Phase 2: PFS based on BICR assessment per RECIST version 1.1.
- Phase 2: Duration of response (DoR) based on BICR assessment per RECIST version 1.1.
- Phase 2: Disease control rate (DC) based on BICR assessment per RECIST version 1.1.
- Phase 2: Overall Survival
- Phase 3: Overall Survival
- Phase 3: OR based on BICR assessment per RECIST version 1.1.
- Phase 3: DoR based on BICR assessment per RECIST version 1.1.
- Phase 3: DC based on BICR assessment per RECIST version 1.1.
- Phase 3: Change from baseline at Week 12 in physical functioning as measured by the EORTC QLQ‑C30
- Phase 3: Change from baseline at Week 12 in key lung cancer symptoms as measured by the EORTC QLQ-LC13.
- Phase 3: Change from baseline at Week 12 in GHS/QoL as measured by the EORTC QLQ-C30.
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG
研究点 (14)
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