SAR408701 vs Docetaxel for Non-Small Cell Lung Cancer
(CARMEN-LC03 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Primary Objectives:* Study was designed with multiple primary endpoints analyzed on randomized participants at the time of the cut-off date for each given analysis (progression free survival \[PFS\] and overall survival \[OS\])* Study success was defined either on PFS or OS* The primary objective was to determine whether tusamitamab ravtansine improves the progression free survival (PFS) when compared to docetaxel in participants with metastatic non-squamous non-small-cell lung cancer (NSCLC) expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor (ICI)* The primary objective was to determine whether tusamitamab ravtansine improves the overall survival (OS) when compared with docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor.Secondary Objectives:* Compared the objective response rate (ORR) of tusamitamab ravtansine with docetaxel* Compared the health-related quality of life (HRQOL) of tusamitamab ravtansine with docetaxel* Evaluated the safety of tusamitamab ravtansine compared to docetaxel* Assessed the duration of response (DOR) of tusamitamab ravtansine as compared with docetaxel
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot be on any other anticancer therapy while participating in this study.
Is the treatment SAR408701 vs Docetaxel safe for humans?
Docetaxel, also known as Taxotere, has been widely used and studied for treating various cancers, including lung cancer. It is generally considered safe, but common side effects include neutropenia (low white blood cell count), peripheral edema (swelling), and less frequently, hypersensitivity reactions. These side effects are usually manageable with proper medical care.12345
What makes the drug tusamitamab ravtansine unique for treating non-small cell lung cancer?
What data supports the effectiveness of the drug docetaxel for treating non-small cell lung cancer?
Docetaxel has been shown to be effective in treating advanced non-small cell lung cancer (NSCLC), both as a single agent and in combination with other drugs. Clinical trials have demonstrated that it improves survival and quality of life for patients, and it is approved for use in both first- and second-line therapy for advanced NSCLC.110111213
Who Is on the Research Team?
Clinical Sciences & Operations
Principal Investigator
Sanofi
Are You a Good Fit for This Trial?
This trial is for adults with non-squamous NSCLC that has spread, who have already tried platinum-based chemo and immune checkpoint inhibitors. They must have a certain level of CEACAM5 in their tumors and be generally healthy enough to participate (ECOG 0-1). Women and men agree to use effective birth control during the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either tusamitamab ravtansine or docetaxel until progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for overall survival and progression-free survival
What Are the Treatments Tested in This Trial?
Interventions
- Docetaxel
- tusamitamab ravtansine
Docetaxel is already approved in United States, European Union, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sanofi
Lead Sponsor
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