Tusamitamab Ravtansine for Non-Small Cell Lung Cancer

(CARMEN-LC06 Trial)

Recruiting at 63 trial locations

Overseen By Trial Transparency email recommended (Toll free number for US & Canada)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sanofi

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a medication called tusamitamab ravtansine for patients with a specific type of lung cancer. The medication targets cancer cells and delivers a substance that helps to destroy them. The trial aims to see if this treatment is safe and effective for these patients.

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

This trial is for adults with a type of lung cancer called NSQ NSCLC who have already tried platinum-based chemotherapy and immune checkpoint inhibitors. They must have tumors with specific protein levels (CEACAM5) and high CEA in their blood, be relatively healthy, able to use birth control, and not have had certain treatments or unresolved health issues.

Inclusion Criteria

I am using or willing to use effective birth control.

My non-squamous NSCLC has worsened after treatments including platinum-based chemotherapy and immunotherapy.

My tumor shows moderate or no CEACAM5 and my CEA levels are high.

Exclusion Criteria

I have brain metastases that haven't been treated or a history of leptomeningeal disease.

My side effects from previous treatments are mild, except for hair loss, skin color changes, or thyroid issues treated with hormones.

I don't have any major illnesses or surgeries that could affect my participation.

Treatment Details

Interventions

• Tusamitamab ravtansine (Monoclonal Antibodies)

Trial Overview The study tests Tusamitamab ravtansine given every two weeks as the only treatment until the disease worsens, side effects become too much, a new cancer therapy starts, or if decided by the patient or doctor. The focus is on its effectiveness, safety profile, and how it moves through the body.

Participant Groups

Group I: Tusamitamab ravtansine Experimental Treatment 1 Intervention

Tusamitamab ravtansine dose will be administered on Day 1 via IV infusion and repeated once every 2 weeks. The duration of 1 cycle will be 14 days (1 administration of tusamitamab ravtansine per cycle).

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University