Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With NSQ NSCLC (CARMEN-LC05)

Inclusion criteria :

- Histologically- or cytologically-confirmed diagnosis of advanced or metastatic NSQ
NSCLC with no EGFR sensitizing mutation or BRAF mutation or ALK/ROS alterations.

- No prior systemic chemotherapy for the treatment of the participant's advanced or
metastatic disease (treatment with chemotherapy and/or radiation as part of
neoadjuvant/adjuvant therapy is allowed as long as completed at least 6 months prior
to diagnosis of advanced or metastatic disease).

- Expression of CEACAM5 as demonstrated prospectively by a centrally assessed
Immunohistochemistry (IHC) assay of ≥2+ in intensity involving at least 1% of the
tumor cell population in archival tumor sample (or if not available fresh biopsy
sample).

- Measurable disease based on RECIST 1.1.

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

- Contraceptive use by men or women should be consistent with local regulations
regarding the methods of contraception for those participating in clinical studies

- Capable of giving signed informed consent

Exclusion criteria:

- Medical condition requiring concomitant administration of a medication with a narrow
therapeutic window and metabolized by CYP450 or a strong CTP3A inhibitor.

- Uncontrolled brain metastases and history of leptomeningeal disease.

- Significant concomitant illness, including any severe medical condition that, in the
opinion of the investigator or Sponsor, 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.

- History of known acquired immunodeficiency syndrome (AIDS) related illnesses or known
HIV disease requiring antiretroviral treatment, or active hepatitis A, B, or C
infection.

- History of active autoimmune disease that has required systemic treatment in the past
2 years.

- History of allogeneic tissue/solid organ transplantation.

- Active infection requiring IV systemic therapy within 2 weeks prior to randomization
or active tuberculosis.

- Interstitial lung disease or history of pneumonitis that has required oral or IV
steroids

- Non-resolution of any prior treatment-related toxicity to < Grade 2 according to NCI
CTCAE V5.0, with the exception of alopecia, vitiligo, or active thyroiditis controlled
with hormone replacement therapy.

- Unresolved corneal disorder or any previous corneal disorder considered by an
ophthalmologist to predict higher risk of drug-induced keratopathy. The use of contact
lenses is not permitted.

- Symptomatic herpes zoster within 3 months prior to screening.

- Significant allergies to humanized monoclonal antibodies.

- Clinically significant multiple or severe drug allergies, intolerance to topical
corticosteroids, or severe post-treatment hypersensitivity reactions (including, but
not limited to, erythema multiforme major, linear immunoglobulin A [IgA] dermatosis,
toxic epidermal necrolysis, and exfoliative dermatitis).

- Concurrent treatment with any other anticancer therapy.

- Have received prior chemotherapy treatment for advanced/metastatic NSCLC.

- The patient is a candidate for a curative treatment with either surgical resection
and/or chemoradiation

- Washout period before the first administration of study intervention of less than 3
weeks or less than 5 times the half-life, whichever is shorter, for any
investigational treatment).

- Any prior therapy targeting CEACAM5.

- Any prior treatment with any other anti-PD-1, or PD-L1 or programmed death ligand 2
(PD-L2), anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4.

- Any prior maytansinoid treatment (DM1 or DM4 ADC).

- Is receiving systemic steroid therapy ≤3 days prior to the first dose of study therapy
or receiving any other form of immunosuppressive medication. Daily steroid replacement
therapy or any corticosteroid premedication if applicable are allowed.

- Any radiation therapy to lung >30 Gy within 6 months of first study intervention
administration.

- Has received or will receive a live vaccine within 30 days prior to the first study
intervention administration.

- Any major surgery within the preceding 3 weeks of the first study intervention
administration.

Prior/concurrent clinical study experience

- Current participation in any other clinical study involving an investigational study
treatment or any other type of medical research.

- Poor organ function

The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.