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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 tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks 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)

Number of Participants With PCSA in Clinical Chemistry

Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology Parameters

+5 more

Awards & Highlights

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.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SAR408701 (tusamitamab ravtansine)Experimental Treatment1 Intervention

Participants received tusamitamab ravtansine 100 milligrams per square meter (mg/m\^2) by intravenous (IV) infusion, once every 2 weeks (Q2W) until objective progressive disease (PD), unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 147 weeks).

Group II: DocetaxelActive Control1 Intervention

Participants received docetaxel 75 mg/m\^2 by IV infusion, once every 3 weeks (Q3W) until objective PD, unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 115 weeks).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SAR408701

2017

Completed Phase 1

~40

0 / 10Eligibility criteria met