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

  • STATUS
    Recruiting
  • End date
    Mar 26, 2024
  • participants needed
    554
  • sponsor
    Sanofi
Updated on 26 September 2021
Investigator
For site information, send an email with site number to
Primary Contact
Investigational Site Number 8400004 (8.5 mi away) Contact
+217 other location
cancer
measurable disease
docetaxel
platinum-based chemotherapy
squamous non-small cell lung cancer

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 (progression 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 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 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 tusamitamab ravtansine with docetaxel
  • To compare the health related quality of life (HRQOL) of tusamitamab ravtansine with docetaxel
  • To evaluate the safety of tusamitamab ravtansine compared to docetaxel
  • To assess the duration of response (DOR) of tusamitamab ravtansine with docetaxel

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).

Details
Condition Non Small Cell Lung Cancer Metastatic
Treatment docetaxel, SAR408701, tusamitamab ravtansine
Clinical Study IdentifierNCT04154956
SponsorSanofi
Last Modified on26 September 2021

Eligibility

Yes No Not Sure

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
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