This study is currently not recruiting participants.

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

Investigating Efficacy and Safety of Investigational Medication in NSQ NSCLC with CEACAM5 Expression

Not Recruiting
18 years or above
All
Phase 2
22 participants needed

Study Overview

This is an open label single group, Phase 2, 1-arm study for treatment to evaluate efficacy, safety, and Pharmacokinetic (PK) of tusamitamab ravtansine in nonsquamous non-small-cell-lung-cancer (NSQ NSCLC) participants with negative or moderate CEACAM5 expression tumors and high circulating carcinoembryonic antigen (CEA).

Participants who will be enrolled, will receive tusamitamab ravtansine as monotherapy every two weeks (Q2W) until disease progression, unacceptable adverse event (AE), initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment, whichever comes first. A total of approximately 38 participants are planned to be treated.

Study Details

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).

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Non-squamous Non-small Cell Lung Cancer
  • Age: 18 years or above
  • Gender: All

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
  • 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

The purpose of this study is to investigate the effects of an investigational medication in participants with nonsquamous non-small-cell lung cancer (NSQ NSCLC) who have negative or moderate CEACAM5 expression tumors and high circulating carcinoembryonic antigen (CEA).

This study evaluates the safety and effectiveness of the investigational medication. It also looks at how the body processes the medication.

  • Who can participate: Participants must have NSQ NSCLC that has progressed after certain treatments and meet specific criteria for CEACAM5 expression and CEA levels. They must also have at least one measurable lesion and a performance status of 0-1. Certain health conditions and previous treatments may exclude participation.
  • Study details: Participants will receive the investigational medication every two weeks. Treatment continues until disease progression or other specified reasons.
  • Study timelines: The study will last 40 weeks.
Updated on 23 May 2026. Study ID: NCT05245071