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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 30 days after last imp administration
Awards & highlights
CARMEN-LC05 Trial 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.Check my eligibility
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.See study design
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.
CARMEN-LC05 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My advanced lung cancer does not have certain genetic changes (EGFR, BRAF, ALK/ROS).
Select...
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.
CARMEN-LC05 Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Disease control rate (DCR)
Duration of response (DOR)
Incidence of anti-therapeutic antibodies (ATAs) against tusamitamab ravtansine
+6 moreCARMEN-LC05 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
~1940
Carboplatin
2014
Completed Phase 3
~6670
Pembrolizumab
2017
Completed Phase 2
~2010
Pemetrexed
2014
Completed Phase 3
~5250
Find a Location
Who is running the clinical trial?
SanofiLead Sponsor
2,163 Previous Clinical Trials
3,512,423 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,019,242 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had any major surgery in the last 3 weeks.You have severe allergies to multiple medications or severe skin reactions after treatment.I am not currently receiving any other cancer treatments.I have not had treatments targeting CEACAM5.I have had chemotherapy for advanced or metastatic non-small cell lung cancer.I have had shingles symptoms within the last 3 months.My advanced lung cancer does not have certain genetic changes (EGFR, BRAF, ALK/ROS).I have a corneal disorder that could worsen with drug treatment and I don't wear contact lenses.I haven't had any cancer other than skin or cervical in the last 3 years, except the one being treated now.I have not had a live vaccine within 30 days before starting the study treatment.You have a disease that can be measured using a specific set of guidelines called RECIST 1.1.I do not have AIDS, HIV needing treatment, or active hepatitis A, B, or C.I have previously received maytansinoid treatment.I haven't had lung radiation over 30 Gy in the last 6 months.I am eligible for treatment aimed at curing my condition through surgery or chemoradiation.I have lung disease or had lung inflammation treated with steroids.You are expected to live for at least 3 more months.You have strong allergies to certain types of medicine called humanized monoclonal antibodies.I have not had treatments targeting PD-1, PD-L1, PD-L2, CD137, or CTLA-4.I haven't had chemotherapy for my advanced or metastatic disease yet.I am on steroids or immunosuppressive medication but only started ≤3 days before the study or it's for replacement.I have received an organ or tissue transplant from another person.I do not have uncontrolled brain cancer spread or a history of cancer in the brain's lining.I am fully active or can carry out light work.All my previous cancer treatment side effects are mild, except for hair loss, skin color loss, or thyroid issues treated with hormones.I haven't taken any experimental treatments recently.My tumor shows CEACAM5 presence in at least 1% of cells.I am taking a strong medication that affects liver enzyme activity.I have not had an infection needing IV treatment or tuberculosis in the last 2 weeks.I have had an autoimmune disease that needed treatment in the last 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: Tusamitamab ravtansine + Pembrolizumab + carboplatin or cisplatin
- Group 2: Tusamitamab ravtansine + Pembrolizumab + carboplatin or cisplatin + pemetrexed
- Group 3: Tusamitamab ravtasine + Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What risks have been identified regarding Tusamitamab ravtansine (SAR408701)?
"Our company's assessment of SAR408701 (Tusamitamab ravtansine) placed its safety at a score 2, as there is only clinical data that supports the drug's security, but none backing up its efficacy."
Answered by AI
How many participants are involved in this research initiative?
"Affirmative. Clinicaltrials.gov has data suggesting that this clinical trial, initially posted on October 26th 2020, is actively seeking participants. In total, 120 people are required to be recruited from 6 various locations."
Answered by AI
Is enrollment for this experiment still open at the present time?
"Affirmative. Clinicaltrials.gov demonstrates that this research study, which was first published on October 26th 2020, is actively looking for participants. 120 patients need to be recruited from 6 locations around the country."
Answered by AI
What results are anticipated from this clinical experiment?
"The main measure of efficacy evaluated in this trial, spanning baseline to 10 months post-treatment, is the objective response rate (ORR) of tusamitamab ravtansine + pembrolizumab and pembrolizumab single agent. Secondary outcomes include time to maximum concentration (Tmax) for each drug as well as duration of response (DOR), defined by RECIST 1.1 or death from any cause, whichever comes first."
Answered by AI
Have any additional studies been conducted involving SAR408701 (Tusamitamab ravtansine)?
"Since 1997, SAR408701 (Tusamitamab ravtansine) has been subject to 1993 completed clinical trials. Currently, 1959 studies are ongoing and many of these experiments take place in Westwood, Kansas."
Answered by AI
What health concerns can SAR408701 (Tusamitamab ravtansine) assist in remedying?
"SAR408701 (Tusamitamab ravtansine) is mainly used in the treatment of cancerous tumours. It has also been utilized to address conditions such as unresectable melanoma, microsatellite instability high, and locally advanced nonsquamous non-small cell lung cancer."
Answered by AI
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