A Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, 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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 490
- 试验地点
- 136
- 主要终点
- Phase 2: Objective Response (OR) Assessed by Blinded Independent Central Review (BICR)
研究概览
简要总结
Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to assess adverse events and change in disease activity of telisotuzumab adizutecan as a monotherapy or in combination with osimertinib compared to standard of care (SOC).
Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. This study will be divided into two stages, in the first stage (phase 2) participants will receive 1 of 2 doses of telisotuzumab adizutecan as a monotherapy or in combination with osimertinib. In the second stage (phase 3) participants will receive the recommended phase 3 dose (RP3D) of telisotuzumab adizutecan, from the previous stage, or SOC. Approximately 490 adult participants with NSCLC will be enrolled in the study in 200 sites around the world.
In phase 2, participants will receive 1 of 2 intravenous (IV) doses of telisotuzumab adizutecan as a monotherapy or in combination with oral osimertinib. In phase 3, participants will receive the IV RP3D of telisotuzumab adizutecan, or SOC. The study will run for a duration of approximately 69 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 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.
- •Provide recently obtained tumor tissue during Screening for c-Met immunohistochemistry (IHC) testing (and study stratification in Phase 2). If recently obtained tumor tissue is not available, archived tumor tissue is also acceptable.
- •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. Participant who has received prior third-generation EGFR TKI therapy in the adjuvant setting must have progressed while on treatment.
- •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.
排除标准
- •Tumor(s) have adenosquamous or squamous histology or sarcomatoid features.
- •Received more than 1 line of systemic therapy in the locally advanced or metastatic setting.
- •Active/symptomatic central nervous system (CNS) metastases. Previously treated brain metastases may be included provided they are radiologically stable.
- •Evidence of active interstitial lung disease (ILD)/pneumonitis or history of ILD or pneumonitis that required steroids.
- •Have any clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation.
研究组 & 干预措施
Phase 3: Stand of Care (SOC)
Participants will receive investigator's choice of SOC, as part of the approximately 69 month study duration.
干预措施: Standard of Care (Drug)
Phase 2: Telisotuzumab Adizutecan Dose A
Participants will receive telisotuzumab adizutecan dose A, as part of the approximately 69 month study duration.
干预措施: Telisotuzumab Adizutecan (Drug)
Phase 2: Telisotuzumab Adizutecan Dose B
Participants will receive telisotuzumab adizutecan dose B, as part of the approximately 69 month study duration.
干预措施: Telisotuzumab Adizutecan (Drug)
Phase 3: Telisotuzumab Adizutecan Recommended Phase 3 Dose
Participants will receive telisotuzumab adizutecan at the recommended phase 3 dose, as part of the approximately 69 month study duration.
干预措施: Telisotuzumab Adizutecan (Drug)
Phase 2: Telisotuzumab Adizutecan Dose A + Osimertinib
Participants will receive telisotuzumab adizutecan dose A in combination with osimertinib, as part of the approximately 69 month study duration.
干预措施: Telisotuzumab Adizutecan (Drug)
Phase 2: Telisotuzumab Adizutecan Dose A + Osimertinib
Participants will receive telisotuzumab adizutecan dose A in combination with osimertinib, as part of the approximately 69 month study duration.
干预措施: Osimertinib (Drug)
Phase 2: Telisotuzumab Adizutecan Dose B + Osimertinib
Participants will receive telisotuzumab adizutecan dose B in combination with osimertinib, as part of the approximately 69 month study duration.
干预措施: Telisotuzumab Adizutecan (Drug)
Phase 2: Telisotuzumab Adizutecan Dose B + Osimertinib
Participants will receive telisotuzumab adizutecan dose B in combination with osimertinib, as part of the approximately 69 month study duration.
干预措施: Osimertinib (Drug)
结局指标
主要结局
Phase 2: Objective Response (OR) Assessed by Blinded Independent Central Review (BICR)
时间窗: Up to Approximately 69 Months
OR is defined as participants achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) per BICR based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Phase 3: Progression-Free Survival (PFS) as assessed by BICR
时间窗: Up to Approximately 69 Months
PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by BICR or death from any cause, whichever occurs earlier.
Phase 2: Objective Response (OR) Assessed by the Blinded Independent Central Review (BICR)
时间窗: Up to Approximately 69 Months
OR is defined as participants achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) per the BICR based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Phase 3: Progression-Free Survival (PFS) as assessed by the BICR
时间窗: Up to Approximately 69 Months
PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by the BICR or death from any cause, whichever occurs earlier.
次要结局
- Phase 2 and 3: Overall Survival (OS) as assessed by BICR(Up to Approximately 69 Months)
- Phase 2: PFS as assessed by BICR(Up to Approximately 69 Months)
- Phase 2 and 3: Duration of Response (DoR) as Assessed by the BICR per RECIST v1.1(Up to Approximately 69 Months)
- Phase 2 and 3: Disease Control (DC) as Assessed by the BICR per RECIST v1.1(Up to Approximately 69 Months)
- Phase 3: OR Assessed by BICR(Up to Approximately 69 Months)
- 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)(Up to Week 12)
- 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)(Up to Week 12)
- Phase 3: Percentage of Participants with Change from Baseline in GHS/QoL as measured by the EORTC QLQ-C30(Up to Week 12)
- Phase 2 and 3: Overall Survival (OS)(Up to Approximately 69 Months)
- Phase 2: PFS as assessed by the BICR(Up to Approximately 69 Months)
- Phase 3: OR Assessed by the BICR(Up to Approximately 69 Months)