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

Launched by SANOFI · Feb 9, 2022

Keywords

ClinConnect Summary

40 weeks (up to 4 weeks for screening, a median of 24 weeks for treatment, and a median of 12 weeks for end of treatment assessments and the safety follow-up visit).

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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
• • 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
• • 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