2025-521124-29-00招募中3 期
Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan Compared to Standard of Care in Subjects with Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer After Progression on a Third-Generation EGFR TKI - AndroMETa-Lung-713
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 9
- 试验地点
- 11
- 主要终点
- Phase 2: Objective Response (OR) Assessed by Blinded Independent Central Review (BICR)
研究概览
简要总结
Phase 2: To evaluate the safety and tolerability of telisotuzumab adizutecan; To evaluate the efficacy of telisotuzumab adizutecan as measured by objective response (OR) per blinded independent central review (BICR); To select the recommended phase 3 dose (RP3D) of telisotuzumab adizutecan; Phase 3: To evaluate the efficacy of telisotuzumab adizutecan compared with standard of care based on progression-free survival (PFS) per BICR assessment.
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
- •Histologically or cytologically confirmed diagnosis of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with documented EGFR Exon 19 deletion or Exon21 L858R mutation as detected by an Federal Drug Administration (FDA)-approved or other validated test in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory (sites in the US) or an accredited local laboratory (sites outside of the US) in accordance with site standard of care.
- •Provide archived or recently obtained tumor tissue during Screening for c-Met immunohistochemistry (IHC) testing (and study stratification in Phase 2).
- •Received one prior third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy in the adjuvant, locally advanced, or metastatic setting, either as monotherapy or in combination with other agents, and experienced documented radiographic disease progression on or after therapy for the most recent regimen administered prior to study entry.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to
- •At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated.
- •Central nervous system (CNS) metastasis, these should be clinically asymptomatic or stable after definitive treatment.
- •Current, historical, or suspected interstitial lung disease (ILD)/pneumonitis that required steroids should be excluded.
排除标准
- •Received more than 1 line of systemic therapy in the locally advanced or metastatic setting.
- •Have any clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation.
结局指标
主要结局
Phase 2: Objective Response (OR) Assessed by Blinded Independent Central Review (BICR)
Phase 2: Objective Response (OR) Assessed by Blinded Independent Central Review (BICR)
Phase 3: Progression-Free Survival (PFS) as assessed by BICR
Phase 3: Progression-Free Survival (PFS) as assessed by BICR
次要结局
- Phase 2 and 3: Overall Survival (OS) as assessed by BICR
- Phase 2: PFS as assessed by BICR
- Phase 2 and 3: Duration of Response (DoR) as Assessed by the BICR per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Phase 2 and 3: Disease Control (DC) as Assessed by the BICR per RECIST v1.1
- Phase 3: OR Assessed by BICR
- Phase 3: Percentage of Participants with Change from Baseline in Physical Functioning as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
- Phase 3: Percentage of Participants with Change from Baseline in Key Lung Cancer Symptoms as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQLC13)
- Phase 3: Percentage of Participants with Change from Baseline 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 (11)
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