SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small Cell Lung Cancer Patients

Official Title

Randomized, Open Label Phase 3 Study of SAR408701 Versus Docetaxel in Previously Treated Metastatic Non- Squamous Non-Small Cell Lung Cancer Patients With CEACAM5 Positive Tumours

Summary:

Primary Objectives: Study is designed with two primary endpoints that will be analyzed on randomized participants at the time of the cutoff 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 SAR408701 improves the progression free survival (PFS) when compared to docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 ≥2+ in intensity in at least 50% of the tumour 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 SAR408701 improves the overall survival (OS) when compared with docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 ≥2+ in intensity in at least 50% of the tumour cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor. Secondary Objectives: - To compare the objective response rate (ORR) of SAR408701 with docetaxel - To compare the health related quality of life (HRQOL) of SAR408701 with docetaxel - To evaluate the safety of SAR408701 compared to docetaxel - To assess the duration of response (DOR) of SAR408701 with docetaxel

Trial Description

Primary Outcome:

  • Progression free survival (PFS)
  • Overall Survival (OS)
Secondary Outcome:
  • 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)
The expected duration of study intervention for participants who benefit from study intervention may vary, based on progression date; but median expected duration of study per participant is estimated as median 9 months in docetaxel arm (1 month for screening, 4 months for treatment, and 4 months for the end of treatment and follow-up visits) and 12.5 months in SAR408701 arm (1 month for screening, 6.5 months for treatment, and 5 months for end of treatment follow-up).

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society