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

Study of Investigational Medication in Non-Small Cell Lung Cancer (NSCLC)

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 <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

Updated on 04 Apr 2025. Study ID: NCT05245071

This study investigates the effects of an investigational medication on non-small cell lung cancer (NSCLC), a type of lung cancer that starts in the cells lining the lungs. The focus is on participants with specific tumor characteristics, including negative or moderate levels of a protein called CEACAM5 and high levels of a substance in the blood known as carcinoembryonic antigen (CEA).

Participants will receive the investigational medication every two weeks. The study will monitor the medication's safety and how it is processed in the body. Treatment will continue until the disease progresses, side effects become unacceptable, a new cancer treatment starts, or the participant or doctor decides to stop.

  • Who can participate: Adults with non-small cell lung cancer that has spread and worsened after specific treatments can participate. Key factors include having certain levels of CEACAM5 and CEA, at least one measurable tumor, and good overall health. Participants must also agree to use effective birth control methods.
  • Study details: Participants will receive the investigational medication alone every two weeks. They will continue treatment until certain conditions are met, such as disease progression or unacceptable side effects. A placebo is not used in this study.
  • Study Timelines: The study will last 40 weeks.