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SAR444245 + Pembrolizumab for Lung Cancer and Mesothelioma
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
Participant must be ≥18 years of age (or country's legal age of majority if >18 years), at the time of signing the informed consent.
All cohorts must have a measurable disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of a new cancer drug, SAR444245, when combined with other anticancer therapies.
Who is the study for?
Adults with Stage IV NSCLC or unresectable malignant pleural mesothelioma can join. They must have measurable disease, no recent severe heart issues, good organ function, and not be pregnant/breastfeeding. Prior treatments vary by cohort: some require no prior therapy for metastatic NSCLC; others allow certain previous treatments.Check my eligibility
What is being tested?
The trial tests SAR444245 combined with other cancer therapies to see its effect on lung cancer/mesothelioma. It aims to determine the right dose, safety profile, how the body processes it (PK), and if it causes an immune response when used with pembrolizumab.See study design
What are the potential side effects?
While specific side effects of SAR444245 are not listed here, common ones from similar trials include fatigue, nausea, skin reactions at injection sites, potential immune-related issues affecting organs like the liver or lungs, and infusion reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at least 18 years old or the legal adult age in my country.
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My cancer can be measured by tests or scans.
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I have had one treatment that includes anti-PD1/PD-L1 and one chemotherapy.
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I have had 1 or 2 treatments with pemetrexed and platinum for my cancer.
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My cancer is advanced lung cancer or inoperable pleural mesothelioma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
Assessment of SAR444245 safety profile when combined with other anticancer therapies-Serious Adverse Events
Assessment of SAR444245 safety profile when combined with other anticancer therapies-Treatment Emergent Adverse Events
Clinical benefit rate
+6 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
4Treatment groups
Experimental Treatment
Group I: Cohort C1: :Mesotheloma 2/3rd line therapyExperimental Treatment2 Interventions
SAR444245 + pembrolizumab, on day 1 of a 21-day treatment cycle (up 35 cycles).
Group II: Cohort B1: Non-small cell lung cancer 2/3rd line therapyExperimental Treatment2 Interventions
SAR444245 + pembrolizumab, on day 1 of a 21-day treatment cycle (up 35 cycles).
Group III: Cohort A2: Non-small cell lung cancer 1rst line therapy with Tumor proportion score 1-49%Experimental Treatment2 Interventions
SAR444245 + pembrolizumab, on day 1 of a 21-day treatment cycle (up 35 cycles).
Group IV: Cohort A1: Non-small cell lung cancer 1rst line therapy with Tumor proportion score > 50%Experimental Treatment2 Interventions
SAR444245 + pembrolizumab, on day 1 of a 21-day treatment cycle (up 35 cycles).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
SanofiLead Sponsor
2,165 Previous Clinical Trials
3,515,196 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,896 Previous Clinical Trials
5,062,612 Total Patients Enrolled
18 Trials studying Mesothelioma
3,811 Patients Enrolled for Mesothelioma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your oxygen levels in your blood are lower than 92%.I am at least 18 years old or the legal adult age in my country.I am not pregnant, breastfeeding, and if able to have children, I agree to use contraception and undergo pregnancy tests.I need corticosteroids for another health issue.My cancer can be measured by tests or scans.I have previously received IL-2-based cancer treatment.I have advanced NSCLC and haven't received systemic therapy for it, but may have had adjuvant/neoadjuvant therapy over 6 months ago.You need to have a high level of PD-L1 expression (TPS ≥ 50%) to be in this group.I haven't had a serious heart problem in the last 6 months.I am able to understand and sign the consent form.I haven't taken antibiotics (except skin ones) in the last 14 days.My organs are not working well.I do not have active brain tumors or cancer in the lining of my brain.I have another cancer that is getting worse or needs treatment in the last 3 years.My bone marrow does not function well.I have had one treatment that includes anti-PD1/PD-L1 and one chemotherapy.I haven't had cancer treatment or major surgery in the last 28 days.I have an autoimmune disease that needed treatment in the last 2 years.I have not received a live-virus vaccine in the last 28 days.I have received an organ or tissue transplant from another person.I have received treatment for cancer before.I am a male and agree to follow the study's rules on not donating sperm and using contraception or abstaining from sex.You have a level of PD-L1 expression between 1% and 49%.I have had 1 or 2 treatments with pemetrexed and platinum for my cancer.My cancer is advanced lung cancer or inoperable pleural mesothelioma.I need some help with daily activities due to my health condition.I have previously been treated with a PD1/PD-L1 inhibitor, or was in a control group for such treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort B1: Non-small cell lung cancer 2/3rd line therapy
- Group 2: Cohort C1: :Mesotheloma 2/3rd line therapy
- Group 3: Cohort A1: Non-small cell lung cancer 1rst line therapy with Tumor proportion score > 50%
- Group 4: Cohort A2: Non-small cell lung cancer 1rst line therapy with Tumor proportion score 1-49%
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 upper limit has been set for patient enrollment in this clinical experiment?
"This particular trial has reached its maximum patient capacity, as it was last updated on October 31st 2022. If you are seeking alternative clinical studies, there are 1690 trials for lung cancer and 2322 studies involving SAR444245 that remain open to recruitment."
Answered by AI
Has SAR444245 been granted official clearance by the FDA?
"SAR444245 has been evaluated for safety, scoring a 2 on our scale from 1 to 3. As this is only at the Phase 2 level of testing, there are some data that show safety but no evidence yet supporting efficacy."
Answered by AI
Are there any available slots for volunteers who wish to participate in this experiment?
"According to clinicaltrials.gov, this medical research is not actively recruiting patients at present, despite being uploaded on the 23rd of September 2021 and updated as recently as October 31st 2022. While there are no openings in this trial currently, 4012 other studies have open positions for participants."
Answered by AI
What additional experiments have been undertaken to investigate SAR444245?
"SAR444245 was first researched back in 1997 at City of Hope Comprehensive Cancer Center and since then, there have been 2613 clinical trials completed. As of now, 2322 live studies are being undertaken with a number of them located in Nashville, Tennessee."
Answered by AI
What medical application does SAR444245 typically serve?
"SAR444245 is primarily prescribed to treat malignant neoplasms, with additional applications such as treating unresectable melanoma, microsatellite instability high tumours, and locally advanced nonsquamous non-small cell lung cancer."
Answered by AI
In what areas can patients access this clinical trial?
"Currently, 10 clinical trial sites are enrolling patients in this research. This includes Investigational Site Number 8400003 located in Nashville, Mount Sinai Medical Center-Site Number:8400006 situated in New york City, and Investigational Site Number :8401009 found within Cleveland's city limits."
Answered by AI
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