Non-Small Cell Lung Cancer study: SAR445877
Official title A Phase 2 Platform Study of Immunomodulatory Compounds in ICI-refractory Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT07133425
What this study is testing
What is SAR445877?
SAR445877 is an investigational medicine being studied to see if it can help control non-small cell lung cancer in people who have already received a type of immune therapy.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if the drug SAR445877 can help control non-small cell lung cancer in patients who have already tried immunotherapy.
- Who it's for
- The study is looking for adults with non-small cell lung cancer that has spread or is locally advanced and did not respond to previous immunotherapy.
- What's involved
- Participants will receive the study drug and undergo regular medical tests and check-ups to monitor how their body reacts and how the cancer is responding.
- Time commitment
- The source text does not specify the total duration of the study or the exact number of visits required.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Eligibility Criteria
- Ability to understand and willingness to sign informed consent form (ICF) prior to initiation of the study and any study procedures.
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of SAR445877 in participants \<18 years of age, children...
- Prior immune checkpoint inhibitor (anti-PD-(L)1) exposure. Participants need to have received at least 6 weeks of exposure to anti-PD-(L)1 and...
- One lesion suitable for repeat biopsy without significant risk to the participant.
You likely can't join if
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drugs.
- Participants who are pregnant or breastfeeding.
- Participants with an active, known or suspected autoimmune disease.
- Participants with a condition requiring systemic treatment with either corticosteroid (\>10 mg daily prednisone equivalent) or other...
- History of interstitial lung disease (ILD) or checkpoint inhibitor-induced pneumonitis.
- Known history of positive test for human immunodeficiency virus or known acquired immunodeficiency syndrome.
See the full eligibility criteria
Who can join
- Eligibility Criteria
- Ability to understand and willingness to sign informed consent form (ICF) prior to initiation of the study and any study procedures.
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of SAR445877 in participants \<18 years of age, children are excluded from this study.
- Prior immune checkpoint inhibitor (anti-PD-(L)1) exposure. Participants need to have received at least 6 weeks of exposure to anti-PD-(L)1 and developed disease progression.
- One lesion suitable for repeat biopsy without significant risk to the participant.
- Measurable disease per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 .
- Hemoglobin \>9.0 g/dL
- Absolute neutrophil count ≥1000/mcL
- Platelets ≥75,000/mcL
- Total bilirubin ≤1.5 institutional upper limit of normal (ULN). Documented Gilbert syndrome is allowed if total bilirubin is ≤3 × ULN.
- AST/ALT ≤2.5 × institutional ULN. Transaminases up to 5 × ULN in the presence of liver metastases.
- Measured or calculated creatinine clearance (CrCl; glomerular filtration rate can also be used in place of creatinine or CrCl) ≥30 mL/min (CrCl should be calculated per institutional standard).
- For participants not receiving therapeutic anticoagulation: international normalized ratio or activated partial thromboplastin time ≤1.5 × ULN.
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result at screening.
- WOCBP must agree to use highly effective contraception for the duration of study participation and for 60 days after completion of study treatment.
- Willing to undergo mandatory biopsies and blood collections as required by the study.
- Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression and participant is clinically stable without...
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible...
What rules you out
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drugs.
- Participants who are pregnant or breastfeeding.
- Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or...
- Participants with a condition requiring systemic treatment with either corticosteroid (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study treatment initiation.
- History of interstitial lung disease (ILD) or checkpoint inhibitor-induced pneumonitis.
- Known history of positive test for human immunodeficiency virus or known acquired immunodeficiency syndrome.
- Acute or chronic hepatitis B virus or hepatitis C virus infection. Prior viral exposure with cleared or fully treated infection based on negative HCV viral load is permitted.
- Previous solid organ or allogeneic hematopoietic stem cell transplant.
- Active infection requiring IV antibiotics or other uncontrolled intercurrent illness requiring hospitalization.
- Significant cardiovascular/cerebrovascular disease, including stroke, myocardial infarction, or prolonged QTc (\> 480msec) within 3 months.
- Participants who have not recovered from AEs due to prior anticancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia, hearing loss, grade 2 neuropathy or endocrinopathy managed with...
- Participants who have previously been treated with PD-1, PD-L1, or CTLA-4 inhibitors and required permanent discontinuation or systemic immunosuppression (e.g. immune inhibitory monoclonal antibodies) due to irAEs.
- Participants who are receiving any other investigational agents.
- Treatment with a live, attenuated vaccine within 4 weeks prior to study treatment initiation, or anticipation of need for such a vaccine during the course of the study or within 5 months after the last dose of study...
- Participants must have adequate washout from prior therapy at the time of study treatment initiation: 4 weeks from major surgery; 4 weeks from antibody-based therapy; 3 weeks from prior PD-(L)1 inhibitor exposure
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, ductal carcinoma in situ, squamous cell carcinoma of the skin that has undergone...
- Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.
- Inability to comply with the study and follow-up procedures.
The study team makes the final eligibility decision.
Where it is enrolling
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.