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SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small Cell Lung Cancer Patients (CARMEN-LC03)

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ClinicalTrials.gov Identifier: NCT04154956
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE November 5, 2019
First Posted Date  ICMJE November 7, 2019
Last Update Posted Date April 8, 2021
Actual Study Start Date  ICMJE February 6, 2020
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
  • Progression free survival (PFS) [ Time Frame: Baseline to up to approximately 15 months ]
    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.
  • Overall Survival (OS) [ Time Frame: Baseline up to approximately 2 years ]
    OS will be defined as the time of randomization to the date of death due to any cause.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2020)
  • Objective response rate (ORR) [ Time Frame: Baseline up to approximately 2 years ]
    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 derived from Overall Response (OR) determined by the Independent Radiology Review Committee (IRC) per Response Evaluation Criteria in Solid Tumor (RECIST) 1.1.
  • Health related quality of life (HRQOL) - disease related symptoms [ Time Frame: Baseline up to median 12 months ]
    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.
  • Health related quality of life (HRQOL) - physical function [ Time Frame: Baseline up to median 12 months ]
    TTD in physical function as determined by EORTC-QLQ-C30.
  • Health related quality of life (HRQOL) - role function [ Time Frame: Baseline up to median 12 months ]
    TTD in role function as determined by EORTC-QLQ-C30.
  • 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) ]
    Incidence of TEAEs and SAEs and laboratory abnormalities according to National Cancer Institute Common Terminology Criteria for Adverse. Events (NCI CTCAE) V5.
  • Duration of response (DOR) [ Time Frame: Baseline up to approximately 2 years ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
  • Objective response rate (ORR) [ Time Frame: Baseline up to approximately 2 years ]
    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.
  • Health related quality of life (HRQOL) - disease related symptoms [ Time Frame: Baseline up to median 12 months ]
    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.
  • Health related quality of life (HRQOL) - physical function [ Time Frame: Baseline up to median 12 months ]
    TTD in physical function as determined by EORTC-QLQ-C30.
  • Health related quality of life (HRQOL) - role function [ Time Frame: Baseline up to median 12 months ]
    TTD in role function as determined by EORTC-QLQ-C30.
  • 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) ]
    Incidence of TEAEs and SAEs and laboratory abnormalities according to National Cancer Institute Common Terminology Criteria for Adverse. Events (NCI CTCAE) V5.
  • Duration of response (DOR) [ Time Frame: Baseline up to approximately 2 years ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
Brief 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 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer Metastatic
Intervention  ICMJE
  • Drug: SAR408701
    Pharmaceutical form: Concentrate for solution for intravenous infusion Route of administration: intravenous (IV) infusion
  • Drug: Docetaxel
    Pharmaceutical form: Concentrate for solution for intravenous infusion Route of administration: IV infusion
    Other Name: TAXOTERE
Study Arms  ICMJE
  • Experimental: SAR408701
    Administered intravenously once every 2 weeks
    Intervention: Drug: SAR408701
  • Active Comparator: Docetaxel
    Administered intravenously once every 3 weeks
    Intervention: Drug: Docetaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 5, 2019)
554
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2024
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 at study entry; 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 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.

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 by imaging performed at least 4 weeks after CNS directed treatment and at least 2 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Portugal,   Romania,   Russian Federation,   Spain,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04154956
Other Study ID Numbers  ICMJE EFC15858
2019-001273-81 ( EudraCT Number )
U1111-1233-0781 ( Other Identifier: UTN )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP