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SAR408701 + Ramucirumab/Pembrolizumab for Lung Cancer (CARMEN-LC04 Trial)
CARMEN-LC04 Trial 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.
CARMEN-LC04 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCARMEN-LC04 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CARMEN-LC04 Trial Design
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Who is running the clinical trial?
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- I haven't had severe bleeding or blood vessel inflammation recently.I have not coughed up a significant amount of blood recently.I need to take certain medications for my health condition.I have not had a gastrointestinal perforation or fistula recently.You have at least one detectable and measurable abnormality according to specific guidelines.I have heart failure or irregular heartbeats that affect my daily life.I am fully active or can carry out light work.My high blood pressure is not controlled, even with medication.My tumor shows a CEACAM5 level of 2+ or higher.There are signs on the X-ray or scan that show the tumor is invading important airways or blood vessels, or that there are holes inside the tumor.I do not have any serious wounds, skin ulcers, or bone fractures that haven't healed.My cancer has worsened after specific treatments.I am currently on blood thinners for treatment.I have not had specific treatments that are not allowed in this trial.I have had a clot in my artery recently.I am not currently receiving any other cancer treatments.I have had inflammatory bowel disease or significant surgery on my intestines.I do not have AIDS, HIV, or ongoing hepatitis.I have not had any other cancer besides skin cancer in the last 3 years.I have brain metastases that haven't been treated and a history of leptomeningeal disease.Certain people cannot participate in this part of the study.My bone marrow, liver, or kidney functions are not good.You have a high level of protein in your urine, unless certain conditions are met.I do not have other major illnesses that could affect my trial participation.My side effects from previous treatments are mild.I have not had major surgery recently.I have ongoing issues with my corneas or I use contact lenses.I have a history of uncontrolled blood clotting or aneurysm.I am not allergic to the study drug or its components.
- Group 1: Ramucirumab + pembrolizumab +SAR408701
- Group 2: Ramucirumab + SAR408701
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What is the capacity of participants for this research endeavor?
"Affirmative. On clinicaltrials.gov, it is noted that this trial commenced recruiting on August 31st 2020 and was last modified November 18th 2022 in search of 36 participants from 12 different medical sites."
What objective is this experiment striving to attain?
"As reported by the trial sponsor, Sanofi, the primary outcome to be measured in this study is Part 1: Incidence of drug-related dose-limiting toxicity (DLT) at Cycle 1 and Cycle 2. Additionally, researchers will assess secondary outcomes related to anti-therapeutic antibodies (ATAs), duration of response (DOR), and peak concentration levels for SAR408701 over a Baseline up to 6 months after the last patient treated time frame."
How many various sites are currently being administered this research endeavor?
"Patients can join this medical trial at Innovative Clinical Research Institute, LLC-Site Number:8400001 in Whittier, California, Roswell Park Cancer Institute-Site Number:8400003 in Buffalo, New york or McClinton Cancer Center-Site Number:8400002 Waco Texas. Additionally there are 12 other sites where people can sign up for the study."
What can you tell me about the risk profile of ramucirumab?
"Based on the data available, Power's evaluation of ramucirumab safety is a 2. This drug has undergone Phase 2 testing and preliminary evidence supports its relative security; however, there are currently no studies quantifying efficacy."
Is this a pioneering clinical trial?
"At this time, 869 cities across 34 nations are hosting 49 active clinical trials for ramucirumab. The initial test for the drug occurred in 2015 under Clovis Oncology, Inc., which included 924 patients and concluded its Phase 2 approval process. Since then, 62 additional studies have been conducted."
Is this research actively seeking volunteers?
"Per the clinicaltrials.gov website, this trial is currently searching for participants and was initially disclosed on August 31st 2020 with a most recent update being issued November 18th 2022."
What maladies does ramucirumab typically combat?
"Ramucirumab has been found to be a suitable treatment for non-small cell lung carcinoma, advanced gastric cancer, and colorectal carcinoma."
Could you please describe any other research that has been done regarding ramucirumab?
"Ramucirumab was initially researched in 2015 at The Royal Marsden NHS Foundation Trust, Downs Road, Sutton. Now there are 62 studies that have been concluded and 49 ongoing medical trials with a significant number located in Whittier, California."
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