NCT05245071

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

Open-label, Phase 2 Study, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine in Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC) Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Non-squamous Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Tusamitamab ravtansine	Pharmaceutical Form: Concentrate for solution Route of Administration: Intravenous infusion

Timeline

• Start date: 2022-06-01
• Primary completion: 2024-03-06
• Completion: 2024-11-20
• First posted: 2022-02-17
• Last updated: 2025-08-29
• Results posted: 2025-03-25

Locations

35 sites across 7 countries: United States, Belgium, France, Italy, Japan, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study