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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
Must not have
Comorbidity requiring corticosteroid therapy
Has received prior IL-2-based anticancer treatment.
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
No Placebo-Only Group

Summary

This trial is testing a new drug called SAR444245 along with other cancer treatments in patients with tumors. The goal is to see if the drug can help shrink tumors and understand how it interacts with other treatments.

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need corticosteroids for another health issue.
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I have previously received IL-2-based cancer treatment.
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I do not have active brain tumors or cancer in the lining of my brain.
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I have another cancer that is getting worse or needs treatment in the last 3 years.
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My bone marrow does not function well.
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I haven't had cancer treatment or major surgery in the last 28 days.
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I have an autoimmune disease that needed treatment in the last 2 years.
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I have received an organ or tissue transplant from another person.
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I need some help with daily activities due to my health condition.

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective response rate (ORR)
Secondary study objectives
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
+4 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999
64%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Pneumonia aspiration
3%
Sepsis
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 3
~2810

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Mesothelioma include chemotherapy, immunotherapy, and emerging immune modulation therapies. Chemotherapy, such as pemetrexed combined with cisplatin, works by killing rapidly dividing cancer cells, but it can also affect healthy cells, leading to significant side effects. Immunotherapy, including drugs like nivolumab and ipilimumab, enhances the body's immune response against cancer cells by targeting immune checkpoints like PD-1/PD-L1 and CTLA-4, which tumors use to evade immune detection. Emerging treatments like SAR444245 focus on immune modulation, aiming to boost the immune system's ability to fight cancer more effectively. These therapies are crucial for Mesothelioma patients as they offer potential for improved outcomes and may provide options for those who do not respond well to traditional treatments.
Novel and Future Treatment Options in Mesothelioma: A Systematic Review.

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,192 Previous Clinical Trials
4,034,129 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,981 Previous Clinical Trials
5,177,903 Total Patients Enrolled
18 Trials studying Mesothelioma
3,811 Patients Enrolled for Mesothelioma

Media Library

Carboplatin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04914897 — Phase 2
Mesothelioma Research Study Groups: Cohort B1: Non-small cell lung cancer 2/3rd line therapy, Cohort C1: :Mesotheloma 2/3rd line therapy, Cohort A1: Non-small cell lung cancer 1rst line therapy with Tumor proportion score > 50%, Cohort A2: Non-small cell lung cancer 1rst line therapy with Tumor proportion score 1-49%
Mesothelioma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04914897 — Phase 2
Carboplatin (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04914897 — Phase 2
~26 spots leftby Oct 2025