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SAR408701 vs Docetaxel for Non-Small Cell Lung Cancer (CARMEN-LC03 Trial)
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.
CARMEN-LC03 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCARMEN-LC03 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CARMEN-LC03 Trial Design
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Who is running the clinical trial?
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- I haven't had any cancer other than skin or cervical pre-cancers in the last 3 years.I have brain metastases that are either untreated or not worsening after treatment.I am a man and agree to use effective birth control during and for 6 months after the study.I have no lasting side effects from previous treatments, except for hair loss, skin color changes, or thyroid issues treated with hormones.I cannot take corticosteroid medication due to health reasons.I have at least one tumor that can be measured.I do not have ongoing eye problems and I don't wear contact lenses.I am not currently receiving any other cancer treatments.I do not have AIDS, untreated HIV, or unresolved hepatitis.I agree to use effective birth control during and for 7 months after the study.I have been treated with specific drugs like docetaxel or drugs targeting CEACAM5.My tumor shows high levels of CEACAM5 in more than half of its cells.I am not allergic to the study drugs or their components.I am fully active or can carry out light work.My non-squamous NSCLC has worsened after treatments including platinum-based chemotherapy and immune therapy.I am at least 18 years old and have signed the informed consent.My bone marrow, liver, or kidney functions are not good.
- Group 1: SAR408701 (tusamitamab ravtansine)
- Group 2: Docetaxel
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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)."
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."
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."
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."
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."
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."
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."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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