Randomized, open-label, Phase 3 study of SAR408701 versus docetaxel in previously treated, metastatic nonsquamous, non-small-cell lung cancer patients with CEACAM5-positive tumors
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
• Study is designed with two primary endpoints that will be analyzed on randomized participants at the time of the cut-off date for each given analysis (progressive free survival [PFS] and overall survival [OS]). • Study success is defined either on PFS or OS • The primary objective is to determine whether tusamitamab ravtansine improves the progression free survival (PFS) when compared to docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor (ICI) • The primary objective is to determine whether tusamitamab ravtansine improves the overall survival (OS) when compared with docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor.
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
- 是
入选标准
- •At least 18 years of age or above (or country’s legal age of maturity if above 18 years) and signed the informed consent.
- •Histologically or cytologically proven diagnosis of non-squamous NSCLC with metastatic disease at study entry; progression after platinum-based chemotherapy and immune checkpoint inhibitor.
- •Participants with carcinoembryonic antigen-related cell adhesion molecule (CEACAM) 5 expression of greater than or equal to 2+ in archival tumor sample (or if not available, fresh biopsy sample) involving at least 50% of the tumor cell population as demonstrated prospectively by central laboratory via immune histochemistry (IHC).
- •At least one measurable lesion by RECIST v1.1 as determined by local site investigator /radiologist assessment.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •A female participant who agrees to use highly effective contraceptive methods during and for at least 7 months after the last dose of study intervention.
- •A male participant who agrees to use highly effective contraception methods during and for at least 6 months after the last dose of study intervention.
排除标准
- •Patients with untreated brain metastases and history of leptomeningeal disease. if previously treated brain metastases no documentation of non-progressive disease in brain by imaging performed at least 4 weeks after CNS directed treatment and at least 2 weeks prior to the first dose of study intervention.
- •Previous enrollment in this study and current participation in any other clinical study involving an investigational study treatment or any other type of medical research.
- •Poor bone marrow, liver or kidney functions
- •Hypersensitivity to any of the study interventions, or components thereof (EDTA), or drug (paclitaxel, polysorbate 80) or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
- •Significant concomitant illnesses, including all severe medical conditions that would impair the patient’s participation in the study or interpretation of the results.
- •History within the last 3 years of an invasive malignancy other than the one treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment.
- •Non-resolution of any prior treatment related toxicity to less than grade 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (V) 5.0, except for alopecia, vitiligo and active thyroiditis controlled with hormonal replacement therapy
- •History of known acquired immunodeficiency syndrome (AIDS) related illnesses or known HIV disease requiring antiretroviral treatment, or unresolved viral hepatitis
- •Previous history of and/or unresolved corneal disorders. The use of contact lenses is not permitted.
- •Concurrent treatment with any other anticancer therapy.
- •Prior treatment with docetaxel or maytansinoid derivatives (DM1 or DM4 antibody drug conjugate) or any drug targeting CEACAM
- •Contraindication to use of corticosteroid premedication.
结局指标
主要结局
Progression free survival (PFS)
Progression free survival (PFS)
Overall Survival (OS)
Overall Survival (OS)
次要结局
- Objective response rate (ORR)
- Health related quality of life (HRQOL) - disease related symptoms
- Health related quality of life (HRQOL) - physical function
- Health related quality of life (HRQOL) - role function
- Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
- Duration of response (DOR)
研究者
Clinical Sciences and Operations
Scientific
Sanofi-Aventis Recherche & Developpement