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

Inclusion Criteria:

• At least 18 years of age or above (or country's legal age of maturity if above 18years) and signed the informed consent.

• Histologically or cytologically proven diagnosis of non-squamous NSCLC withmetastatic disease at study entry; progression after platinum-based chemotherapy andimmune checkpoint inhibitor.

• Participants with carcinoembryonic antigen-related cell adhesion molecule (CEACAM) 5expression of greater than or equal to 2+ in archival tumor sample (or if notavailable, fresh biopsy sample) involving at least 50% of the tumor cell populationas demonstrated prospectively by central laboratory via immune histochemistry (IHC).

• At least one measurable lesion by RECIST v1.1 as determined by local siteinvestigator /radiologist assessment.

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

• A female participant who agreed to use highly effective contraceptive methods duringand for at least 7 months after the last dose of study intervention.

• A male participant who agreed to use highly effective contraception methods duringand for at least 6 months after the last dose of study intervention.

Exclusion Criteria:

• Participants with untreated brain metastases and history of leptomeningeal disease.if previously treated brain metastases no documentation of non-progressive diseasein brain by imaging performed at least 4 weeks after CNS directed treatment and atleast 2 weeks prior to the first dose of study intervention.

• Significant concomitant illnesses, including all severe medical conditions thatwould impair the participation in the study or interpretation of the results.

• History within the last 3 years of an invasive malignancy other than the one treatedin this study, with the exception of resected/ablated basal or squamous-cellcarcinoma of the skin or carcinoma in situ of the cervix, or other local tumorsconsidered cured by local treatment.

• Non-resolution of any prior treatment related toxicity to less than grade 2according to National Cancer Institute Common Terminology Criteria for AdverseEvents (NCI CTCAE) version (V) 5.0, except for alopecia, vitiligo and activethyroiditis controlled with hormonal replacement therapy

• History of known acquired immunodeficiency syndrome (AIDS) related illnesses orknown HIV disease requiring antiretroviral treatment, or unresolved viral hepatitis

• Previous history of and/or unresolved corneal disorders. The use of contact lenseswas not permitted.

• Concurrent treatment with any other anticancer therapy.

• Prior treatment with docetaxel or maytansinoid derivatives (DM1 or DM4 antibody drugconjugate) or any drug targeting CEACAM5.

• Contraindicated the use of corticosteroid premedication.

• Previous enrollment in this study and current participation in any other clinicalstudy involving an investigational study treatment or any other type of medicalresearch.

• Poor bone marrow, liver or kidney functions

• Hypersensitivity to any of the study interventions, or components thereof (EDTA), ordrug (paclitaxel, polysorbate 80) or other allergy that, in the opinion of theInvestigator, contraindicated participation in the study.

The above information was not intended to contain all considerations relevant to a potential participation in a clinical trial.