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Antineoplastic Agents

Tusamitamab Ravtansine + Pembrolizumab + Chemotherapy for NSCLC (CARMEN-LC05 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

Histologically- or cytologically-confirmed diagnosis of advanced or metastatic NSQ NSCLC with no EGFR sensitizing mutation or BRAF mutation or ALK/ROS alterations

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Must not have

Concurrent treatment with any other anticancer therapy

Any prior therapy targeting CEACAM5

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 30 days after last imp administration

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer drug, tusamitamab ravtansine, to see if it is safe and effective when used with other drugs to treat non-small cell lung cancer.

Who is the study for?

This trial is for adults with advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSQ NSCLC) without certain genetic mutations. Participants should not have had prior systemic chemotherapy for their advanced disease, must have a life expectancy of at least 3 months, and be in good physical condition (ECOG 0-1). They need to use contraception and have tumors expressing CEACAM5.

What is being tested?

The study tests Tusamitamab Ravtansine (SAR408701) combined with Pembrolizumab, with or without platinum-based chemotherapy and Pemetrexed. It aims to find the best doses for safety and effectiveness against lung cancer by observing tumor response and monitoring drug levels in the body.

What are the potential side effects?

Potential side effects may include allergic reactions to monoclonal antibodies, immune system complications due to PD-1/PD-L1 inhibitors like Pembrolizumab, issues from platinum-based chemo such as nausea or nerve damage, and risks associated with Pemetrexed including kidney problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My advanced lung cancer does not have certain genetic changes (EGFR, BRAF, ALK/ROS).

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I am fully active or can carry out light work.

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My tumor shows CEACAM5 presence in at least 1% of cells.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not currently receiving any other cancer treatments.

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I have not had treatments targeting CEACAM5.

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I have had chemotherapy for advanced or metastatic non-small cell lung cancer.

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I have a corneal disorder that could worsen with drug treatment and I don't wear contact lenses.

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I have not had a live vaccine within 30 days before starting the study treatment.

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I do not have AIDS, HIV needing treatment, or active hepatitis A, B, or C.

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I have previously received maytansinoid treatment.

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I have lung disease or had lung inflammation treated with steroids.

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I have not had treatments targeting PD-1, PD-L1, PD-L2, CD137, or CTLA-4.

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I have received an organ or tissue transplant from another person.

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I do not have uncontrolled brain cancer spread or a history of cancer in the brain's lining.

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I am taking a strong medication that affects liver enzyme activity.

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I have not had an infection needing IV treatment or tuberculosis in the last 2 weeks.

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I have had an autoimmune disease that needed treatment in the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 30 days after last imp administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 30 days after last imp administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 30 days after last imp administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Drug-related dose-limiting toxicity (DLTs)

Expansion part (including participants treated at the recommended dose for expansion [RDE] from the Safety Run-in part): Objective response rate (ORR)

Incidence of study drug-related dose-limiting toxicity (DLTs) at Cycle 1 (C1D1 to C1D21)

Secondary study objectives

Disease control rate (DCR)

Duration of response (DOR)

Incidence of anti-therapeutic antibodies (ATAs) against tusamitamab ravtansine

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Tusamitamab ravtasine + PembrolizumabExperimental Treatment2 Interventions

Pembrolizumab dose will be administered intravenously prior to intravenous administration of tusamitamab ravtansine dose every 3 weeks.

Group II: Tusamitamab ravtansine + Pembrolizumab + carboplatin or cisplatin + pemetrexedExperimental Treatment5 Interventions

Pembrolizumab dose will be administered intravenously prior to intravenous adminstration of tusamitamab ravtansine dose every 3 weeks. Pemetrexed will be infused over 10 minutes after tusamitamab ravtansine infusion on Day 1 and then Q3W. Carboplatin will be infused over 15 to 60 minutes immediately after pemetrexed infusion on Day 1 and Q3W for the first 4 cycles. Cisplatin will be infused approximately 30 minutes after pemetrexed infusion after pemetrexed infusion on Day 1 and Q3W for the first 4 cycles.

Group III: Tusamitamab ravtansine + Pembrolizumab + carboplatin or cisplatinExperimental Treatment4 Interventions

Pembrolizumab dose will be administered intravenously prior to intravenous adminstration of tusamitamab ravtansine dose every 3 weeks. Carboplatin will be infused over 15 to 60 minutes immediately after tusamitamab ravtansine infusion on Day 1 and Q3W for the first 4 cycles. Cisplatin will be infused approximately 30 minutes after tusamitamab ravtansine infusion on Day 1 and Q3W for the first 4 cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~3120

Carboplatin

2014

Completed Phase 3

~6120