Overview

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
Trial end date:
2024-03-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
Treatments:
Docetaxel
Maytansine
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 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.