Clinical Trials /

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

NCT04154956

Description:

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 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 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 tumor 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

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: 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 Tumors

Clinical Trial IDs

  • ORG STUDY ID: EFC15858
  • SECONDARY ID: 2019-001273-81
  • SECONDARY ID: U1111-1233-0781
  • NCT ID: NCT04154956

Conditions

  • Non-small Cell Lung Cancer Metastatic

Interventions

DrugSynonymsArms
SAR408701SAR408701
docetaxelDocetaxel

Purpose

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 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 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 tumor 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

Detailed Description

      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).
    

Trial Arms

NameTypeDescriptionInterventions
SAR408701ExperimentalAdministered intravenously once every 2 weeks
  • SAR408701
DocetaxelActive ComparatorAdministered intravenously once every 3 weeks
  • docetaxel

Eligibility Criteria

        Inclusion criteria :

          -  At least 18 years of age or above (or countries 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 progression after platinum-based chemotherapy and immune checkpoint inhibitor.

          -  Participants with carcinoembryonic antigen-related cell adhesion molecule (CEACAM) 5
             expression of ≥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 0-1.

          -  A female participant who agrees to use effective contraceptive methods during and for
             at least 7 months after the last dose of study intervention.

          -  A male participant who agrees to use effective contraception methods during and for at
             least 4 months after the last dose of study intervention.

        Exclusion criteria:

          -  Patients with untreated brain metastases and history of leptomeningeal disease. if
             previously treated brain metastases no documentation of non-progressive disease in
             brain within 4 weeks prior to the first dose of study intervention.

          -  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 < grade 2 according to NCI
             CTCAE V5.0, 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 CEACAM5.

          -  Contraindication to use of corticosteroid premedication.

          -  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.

        The above information is not intended to contain all considerations relevant to a patient's
        potential participation in a clinical trial.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression free survival (PFS)
Time Frame:Baseline to up to approximately 15 months
Safety Issue:
Description:PFS will be defined as the time from randomization to the date of the first documented disease progression or death of any cause, whichever comes first.

Secondary Outcome Measures

Measure:Objective response rate (ORR)
Time Frame:Baseline up to approximately 2 years
Safety Issue:
Description:Objective response rate will be defined as the proportion of participants who have a complete response (CR) or partial response (PR), as best overall response determined by the Independent Radiology Review Committee (IRC) per Response Evaluation Criteria in Solid Tumor (RECIST) 1.1.
Measure:Health related quality of life (HRQOL) - disease related symptoms
Time Frame:Baseline up to median 12 months
Safety Issue:
Description:Time to deterioration (TTD) in disease related symptoms as determined by European Organization for Research and Treatment for Cancer (EORTC)- Quality of life Questionnaire (QLQ)-Lung Cancer (LC)13.
Measure:Health related quality of life (HRQOL) - physical function
Time Frame:Baseline up to median 12 months
Safety Issue:
Description:TTD in physical function as determined by EORTC-QLQ-C30.
Measure:Health related quality of life (HRQOL) - role function
Time Frame:Baseline up to median 12 months
Safety Issue:
Description:TTD in role function as determined by EORTC-QLQ-C30.
Measure:Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time Frame:Baseline up to end of study (approximately 2 years)
Safety Issue:
Description:Incidence of TEAEs and SAEs and laboratory abnormalities according to National Cancer Institute Common Terminology Criteria for Adverse. Events (NCI CTCAE) V5.
Measure:Duration of response (DOR)
Time Frame:Baseline up to approximately 2 years
Safety Issue:
Description:Duration of response (DOR) is defined as the time from first documented evidence of complete response (CR) or partial response (PR) until progressive disease (PD) determined per RECIST 1.1 or death from any cause, whichever occurs first.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Sanofi

Last Updated