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Taxane

SAR408701 vs Docetaxel for Non-Small Cell Lung Cancer (CARMEN-LC03 Trial)

Phase 3
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A male participant who agrees to use highly effective contraception methods during and for at least 6 months after the last dose of study intervention.
At least one measurable lesion by RECIST v1.1 as determined by local site investigator /radiologist assessment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to approximately 2 years
Awards & highlights

CARMEN-LC03 Trial Summary

This trial is studying tusamitamab ravtansine to see how well it works compared with docetaxel in treating patients with non-small cell lung cancer that has come back or spread and express CEACAM5.

Who is the study for?
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.Check my eligibility
What is being tested?
The trial tests if tusamitamab ravtansine can improve survival without cancer growth (PFS) or overall survival (OS) better than docetaxel in patients with specific protein levels on their lung cancer cells. It also looks at response rates, quality of life, safety, and how long the response lasts.See study design
What are the potential side effects?
Possible side effects include reactions related to infusion, fatigue, issues affecting organs like liver or kidneys based on previous treatments' toxicity levels. Specific side effects will depend on individual patient health conditions.

CARMEN-LC03 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man and agree to use effective birth control during and for 6 months after the study.
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I have at least one tumor that can be measured.
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I agree to use effective birth control during and for 7 months after the study.
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My tumor shows high levels of CEACAM5 in more than half of its cells.
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I am fully active or can carry out light work.
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My non-squamous NSCLC has worsened after treatments including platinum-based chemotherapy and immune therapy.
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I am at least 18 years old and have signed the informed consent.

CARMEN-LC03 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Progression free survival (PFS)
Secondary outcome measures
Duration of response (DOR)
Health related quality of life (HRQOL) - disease related symptoms
Health related quality of life (HRQOL) - physical function
+3 more

CARMEN-LC03 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SAR408701 (tusamitamab ravtansine)Experimental Treatment1 Intervention
Administered intravenously once every 2 weeks
Group II: DocetaxelActive Control1 Intervention
Administered intravenously once every 3 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SAR408701
2017
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,158 Previous Clinical Trials
3,513,937 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,018,544 Total Patients Enrolled

Media Library

Docetaxel (Taxane) Clinical Trial Eligibility Overview. Trial Name: NCT04154956 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: SAR408701 (tusamitamab ravtansine), Docetaxel
Non-Small Cell Lung Cancer Clinical Trial 2023: Docetaxel Highlights & Side Effects. Trial Name: NCT04154956 — Phase 3
Docetaxel (Taxane) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04154956 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the goals that this clinical trial is hoping to achieve?

"The primary outcome of this trial, as measured by the study sponsor Sanofi, will be Progression Free Survival (PFS) over a period of Baseline up to approximately 2 years. Additionally, the trial will evaluate secondary outcomes including Objective Response Rate (ORR), Duration of Response (DOR), and Health-Related Quality of Life (HRQOL)."

Answered by AI

What are the primary conditions that tusamitamab ravtansine has been proven to treat?

"Malignant neoplasms are often treated with tusamitamab ravtansine. Additionally, tusamitamab ravtansine has shown efficacy in treating other conditions such as advance directives, sarcoma, and esophageal neoplasms malignant."

Answered by AI

How many people can sign up for this clinical trial at most?

"In order to run this experiment, 554 individuals who meet the pre-determined criteria must enroll. These potential participants can sign up at locations like Halifax's Investigational Site Number :1240008 and Texas Oncology, PA-Site Number:8400026 in Austin, Texas."

Answered by AI

Are there different research sites for this clinical trial in Canada?

"Along with 58 other potential locations, patients can be enrolled at Investigational Site Number 1240008 in Halifax, Nova Scotia; Texas Oncology, PA-Site Number 8400026 in Austin, Texas; and Arizona Oncology Associates-Site Number 8400024 in Tucson, Arizona."

Answered by AI

Has tusamitamab ravtansine gained regulatory approval from the FDA?

"Tusamitamab ravtansine's safety is estimated to be a 3. This judgement comes from the fact that tusamitamab ravtansine is in Phase 3 clinical trials, where there is some evidence of efficacy as well as multiple rounds of data affirming its safeness."

Answered by AI

Are patients being actively sought for this particular research project?

"That is correct, the information available on clinicaltrials.gov backs up that this trial is currently looking for participants. The posting dates back to February 6th 2020 and was last updated on November 3rd 2022. They are hoping to get 554 people to participate at 58 different locations."

Answered by AI

Are there any other research projects that have looked at tusamitamab ravtansine?

"As of now, there are 337 tusamitamab ravtansine clinical trials underway. 132 of these active studies are in their third phase. Though most research for this treatment is conducted in Fuzhou, Fujian, there are 23,090 locations running tusamitamab ravtansine studies."

Answered by AI

Who else is applying?

What site did they apply to?
Investigational Site Number :1240008
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
~81 spots leftby Mar 2025