Tusamitamab ravtansine in NSQ NSCLC participants with negative or moderate CEACAM5 expression tumors and high circulating CEA

Phase 2

Recruiting

• Conditions: on-squamous non-small cell lung cancer

• Registration Number: JPRN-jRCT2011220001
• Lead Sponsor: Tomoyuki Tanaka

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 38

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 (IHC) 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 - 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified