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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
At least one measurable lesion by RECIST v1.1 as determined by local site investigator /radiologist assessment.
Participants with carcinoembryonic antigen-related cell adhesion molecule (CEACAM) 5 expression of greater than or equal to 2+ in archival tumor sample (or if not available, fresh biopsy sample) involving at least 50% of the tumor cell population as demonstrated prospectively by central laboratory via immune histochemistry (IHC).
Must not have
Contraindication to use of corticosteroid premedication.
Previous history of and/or unresolved corneal disorders. The use of contact lenses is not permitted.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to approximately 2 years
Awards & highlights

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have at least one tumor that can be measured.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot take corticosteroid medication due to health reasons.
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I do not have ongoing eye problems and I don't wear contact lenses.
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I am not currently receiving any other cancer treatments.
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I do not have AIDS, untreated HIV, or unresolved hepatitis.
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I have been treated with specific drugs like docetaxel or drugs targeting CEACAM5.
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My bone marrow, liver, or kidney functions are not good.

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

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

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
2,187 Previous Clinical Trials
3,979,367 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
869 Previous Clinical Trials
2,020,221 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
~74 spots leftby Sep 2025
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