Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA

Who can take part

• Histologically or cytologically proven diagnosis of NSQ NSCLC metastatic disease at study entry; progression after platinum-based chemotherapy and immune checkpoint inhibitor
• Participants with moderate or negative CEACAM5 expression as demonstrated prospectively by central laboratory via immune histochemistry (ICH) and high circulating CEA levels (≥100 ng/mL). Moderate CEACAM5 expression is defined as intensity ≥ 2 + in ≥ 1% and <50 % of tumor cells. Negative CEACAM5 expression is defined as intensity of 1 + whatever the percentage of stained tumor cells or <1% of tumor cells
• At least one measurable lesion by RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Women of childbearing potential or male patient with women of childbearing potential who agree to use highly effective method of birth control

Who cannot take part

• Significant concomitant illness that could impair the participation in the study or interpretation of the results or any major surgery with 3 weeks prior treatment administration
• Nonresolution 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
• Previous history of and/or unresolved corneal disorders. The use of contact lenses is not permitted
• Prior treatment with maytansinoid derivatives (DM1 or DM4 antibody drug conjugate) or any drug targeting CEACAM5
• Concurrent treatment with any other anticancer therapy
• Patients with untreated brain metastases or history of leptomeningeal disease
• 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 uncontrolled infection with human immunodeficiency virus (HIV), or unresolved viral hepatitis
• Poor bone marrow, liver or kidney functions; The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial