Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
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).
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA
