Calendario›SNY›SAR408701 · CARMEN-LC03
SAR408701 · CARMEN-LC03
SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients
Ensayo de Sanofi en Non-small Cell Lung Cancer Metastatic (del registro, en inglés).
- Fase
- Fase 3
- Estado
- Interrumpido
- Participantes
- 389
- Centros
- 169
- Fin del objetivo primario
- sep 2023
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en feb 2020.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Sponsor decision, the decision is not related to any safety concern.».
Qué mide
Progression-free Survival (PFS) (Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objectives: * Study was designed with multiple primary endpoints analyzed on randomized participants at the time of the cut-off date for each given analysis (progression free survival \[PFS\] and overall survival \[OS\]) * Study success was defined either on PFS or OS * The primary objective was to determine whether tusamitamab ravtansine improves the progression free survival (PFS) when compared to docetaxel in participants with metastatic non-squamous non-small-cell lung cancer (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 was 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. Secondary Objectives: * Compared the objective response rate (ORR) of tusamitamab ravtansine with docetaxel * Compared the health-related quality of life (HRQOL) of tusamitamab ravtansine with docetaxel * Evaluated the safety of tusamitamab ravtansine compared to docetaxel * Assessed the duration of response (DOR) of tusamitamab ravtansine as compared with docetaxel
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Ficha completa en ClinicalTrials.gov (NCT04154956), actualizada en abr 2026.