2024-514465-18-00招募中2 期
An Open-label Multi-Cohort Phase 1b/2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of ABBV-400 in Combination with Budigalimab in Advanced or Metastatic Non-Squamous NSCLC with No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations (AndroMETa-Lung-536)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 38
- 主要终点
- Part 1: dose-limiting toxicity.
研究概览
简要总结
To evaluate the safety, tolerability, efficacy and optimal recommended Phase 3 dose (RP3D) of ABBV-400 in combination with budigalimab.
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
- •Subject must have had no prior systemic therapy for locally advanced or metastatic NSCLC including PD-L1/PD-L2 inhibitor, CTLA-4 inhibitor, TIM 3 inhibitors, or any other immunotherapy Subject may have received prior adjuvant/neoadjuvant systemic therapy and/or radiation as defined in protocol (Allowed for 1L pts), in both parts.
- •Subject must have received 1 line of prior systemic therapy in the locally advanced or metastatic setting (Neoadjuvant and adjuvant systemic therapy would count as a prior line). Eligibility for subjects with or without actionable gene alterations will be defined in protocol (Allowed for 2L pts), on part 1 only.
排除标准
- •For 1L subjects in Part 1 and 2: Subjects with EGFR or other genomic aberration (e.g., ALK, ROS1, KRAS G12C, BRAFV600E, NTRK1,2,3, RET1, HER-2, MET exon 14 skipping, etc.) for which a locally approved targeted therapy is available for first-line treatment.
- •Subject with prior treatment of a c-Met targeting antibody (e.g., ABBV-400, ABBV-399 or topoisomerase-inhibitor containing regimen. Prior treatment with MET tyrosine kinase inhibitors is allowed.
- •Subject with known uncontrolled metastases to the CNS.
结局指标
主要结局
Part 1: dose-limiting toxicity.
Part 1: dose-limiting toxicity.
Part 2: efficacy endpoint is the OR as assessed by BICR (as confirmed CR or PR based on RECIST v1.1).
Part 2: efficacy endpoint is the OR as assessed by BICR (as confirmed CR or PR based on RECIST v1.1).
次要结局
- Progression Free Survival (PFS): the time from the subject's randomization date to the first occurrence of radiographic progression per BICR based on RECIST v1.1 or death from any cause, whichever occurs earlier.
- Duration Of Response (DOR): the time from the first documented CR or PR per BICR to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause, whichever occurs first.
- Disease Control: best overall response of confirmed CR or confirmed PR, or SD for at least 12 weeks following randomization date based on RECIST v1.1, by the BICR. OR, PFS, DOR, and DC by investigator per RECIST v1.1.
- Overall Survival: the time from subject's randomization date (Part 2) or first dose date of study treatment (Part 1) to the event of death from any cause. Subjects with no documented death will be censored at the last known alive date.
- OR, PFS, OS, DOR, and DC in PD-L1 subgroups.
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG
研究点 (38)
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