Trial purpose
Cancer treatment
Tumor type
Lung cancer
Age
18+
Clinical summary
Summary
This study has several cohorts, based on participants' cancer type and treatment history.
- Cohort A1 will enrol people with non-small cell lung cancer, 1st line therapy with tumour proportion score > 50%.
- Cohort A2 will enrol people with non-small cell lung cancer, 1st line therapy with tumour proportion score 1-49%.
- Cohort B1 will enrol people with non-small cell lung cancer, 2nd or 3rd line therapy.
- Cohort C1 will enrol people with mesothelioma, 2nd or 3rd line therapy.
All cohortsw ill receive SAR444245 (also called THOR-707) as an IV infusion plus pembrolizumab immunotherapy as an IV infusion on Day 1 of a 21-day treatment cycle (up to 35 cycles).
Conditions
This trial is treating people with non-small cell lung cancer or pleural mesothelioma
Eligibility
Exclusion
Participants are excluded from the study if any of the following criteria apply:
- Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 2.
- Poor bone marrow reserve
- Poor organ function
- Participants with baseline SpO2 ≤ 92%.
- Active brain metastases or leptomeningeal disease.
- History of allogenic tissue/solid organ transplant
- Last administration of prior antitumor therapy or any investigational treatment within 28 days or less than 5 times the half-life, whichever is shorter; major surgery or local intervention within 28 days.
- Has received prior IL-2-based anticancer treatment.
- Comorbidity requiring corticosteroid therapy
- Antibiotic use (excluding topical antibiotics) ≤14 days prior to first dose of IMP
- Severe or unstable cardiac condition within 6 months prior to starting study treatment
- Active, known, or suspected autoimmune disease that has required systemic treatment in the past 2 years
- Known second malignancy either progressing or requiring active treatment within the last 3 years
- Cohorts A1, A2, and C1: Prior treatment with an agent (approved or investigational) that blocks the PD1/PD-L1 pathway (participants who joined a study with an anti-PD1/PD-L1 but have written confirmation they were on control arm are allowed).
- Receipt of a live-virus vaccination within 28 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
- NCT04914897 *
- U1111-1254-0107; MK-3475-B71; KEYNOTE-B71 ; 2020-005331-78
Trial sponsor
Sanofi
Scientific Title
A Phase 2 Non-randomized, Open-label, Multi-cohort, Multi-center Study Assessing the Clinical Benefit of SAR444245 (THOR-707) Combined With Other Anticancer Therapies for the Treatment of Participants With Lung Cancer or Pleural Mesothelioma
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