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Monoclonal Antibodies

SAR408701 + Ramucirumab/Pembrolizumab for Lung Cancer (CARMEN-LC04 Trial)

Phase 2
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
CEACAM5 expression of ≥2+ in archival or fresh tumor sample
Metastatic disease progression fulfilling specific criteria related to platinum-based chemotherapy and immune checkpoint inhibitor treatment
Must not have
Medical condition requiring concomitant administration of specified medications
Clinically relevant congestive heart failure or poorly controlled cardiac arrhythmia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from cycle 1 day 1 up to cycle 2 day 14, approximately 28 days
Awards & highlights

Summary

This trial is testing a new combination drug therapy for people with non-small cell lung cancer that has progressed despite other treatments. The goal is to see if the new therapy is safe and effective.

Who is the study for?
This trial is for patients with advanced non-small cell lung cancer who've seen their disease progress after platinum-based chemo and immune therapy. They must have a certain level of CEACAM5 in tumors, at least one measurable lesion, be relatively fit (ECOG 0-1), and agree to use birth control post-treatment.
What is being tested?
The study tests tusamitamab ravtansine combined with ramucirumab or both drugs plus pembrolizumab in those previously treated for NSCLC. It aims to find the right dose, check safety, measure how long the treatment works, and monitor its effect on tumor growth.
What are the potential side effects?
Potential side effects include reactions related to infusion treatments, fatigue, issues affecting organs like liver or kidneys due to drug toxicity, blood disorders that can affect clotting or immunity, and possibly increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor shows a CEACAM5 level of 2+ or higher.
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My cancer has worsened after specific treatments.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need to take certain medications for my health condition.
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I have heart failure or irregular heartbeats that affect my daily life.
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My high blood pressure is not controlled, even with medication.
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I am currently on blood thinners for treatment.
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I have not had specific treatments that are not allowed in this trial.
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I am not currently receiving any other cancer treatments.
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I have had inflammatory bowel disease or significant surgery on my intestines.
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I do not have AIDS, HIV, or ongoing hepatitis.
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I have brain metastases that haven't been treated and a history of leptomeningeal disease.
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My bone marrow, liver, or kidney functions are not good.
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My side effects from previous treatments are mild.
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I have ongoing issues with my corneas or I use contact lenses.
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I have a history of uncontrolled blood clotting or aneurysm.
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I am not allergic to the study drug or its components.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from cycle 1 day 1 up to cycle 2 day 14, approximately 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and from cycle 1 day 1 up to cycle 2 day 14, approximately 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Doublet Cohort - Part 1: Number of Participants With Study Drug-Related Dose-Limiting Toxicity (DLT)
Doublet Cohort - Part 2: Objective Response Rate (ORR)
Triplet Cohort: Number of Participants With Study Drug-Related Dose-Limiting Toxicity
Secondary study objectives
Doublet Cohort: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 14 Days (AUC0-14d) of Tusamitamab Ravtansine and Ramucirumab
Doublet Cohort: Concentration Observed Before Treatment Administration During Repeated Dosing (Ctrough) of Tusamitamab Ravtansine and Ramucirumab
Doublet Cohort: Disease Control Rate (DCR)
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Ramucirumab + pembrolizumab +SAR408701Experimental Treatment3 Interventions
Participants will be treated with tusamitamab ravtansine and ramucirumab and pembrolizumab to assess the tolerability of the combination
Group II: Ramucirumab + SAR408701Experimental Treatment2 Interventions
Ramucirumab will be administered intravenously prior to intravenously adminstration of SAR408701 every two 2 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SAR408701
2017
Completed Phase 1
~40
ramucirumab
2021
Completed Phase 3
~660
pembrolizumab
2017
Completed Phase 3
~6070

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,187 Previous Clinical Trials
3,979,747 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
869 Previous Clinical Trials
2,020,601 Total Patients Enrolled

Media Library

Ramucirumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04394624 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Ramucirumab + pembrolizumab +SAR408701, Ramucirumab + SAR408701
Non-Small Cell Lung Cancer Clinical Trial 2023: Ramucirumab Highlights & Side Effects. Trial Name: NCT04394624 — Phase 2
Ramucirumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04394624 — Phase 2
~6 spots leftby Sep 2025
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