Actively Recruiting
A Phase 2 Platform Study of Immunomodulatory Compounds in ICI-refractory Non-small Cell Lung Cancer
Led by M.D. Anderson Cancer Center · Updated on 2026-04-16
29
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
S
Sanofi
Collaborating Sponsor
AI-Summary
What this Trial Is About
To learn if SAR445877 can help to control locally advanced or metastatic NSCLC in patients who have previously received ICI therapy.
CONDITIONS
Official Title
A Phase 2 Platform Study of Immunomodulatory Compounds in ICI-refractory Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign informed consent before starting the study
- Age 18 years or older
- Histologically confirmed locally advanced or metastatic NSCLC with disease progression after all available standard therapies
- Prior exposure to immune checkpoint inhibitors (anti-PD-(L)1) for at least 6 weeks with disease progression
- At least one tumor lesion suitable for repeat biopsy without significant risk
- Measurable disease per RECIST v1.1 criteria
- ECOG performance status of 0 or 1
- Adequate organ and marrow function as specified (hemoglobin >9.0 g/dL, neutrophils ≥1000/mcL, platelets ≥75,000/mcL, bilirubin ≤1.5× ULN, AST/ALT ≤2.5× ULN or ≤5× ULN with liver metastases, creatinine clearance ≥30 mL/min)
- For women of childbearing potential, negative pregnancy test and agreement to use effective contraception during and 60 days after study treatment
- Male participants must agree to use contraception and avoid sperm donation during and 60 days after treatment
- Willingness to undergo mandatory biopsies and blood collections
- Participants with treated, stable brain metastases without steroid treatment for at least 7 days prior to study
- Participants with other prior or concurrent malignancies that do not interfere with safety or efficacy assessment
You will not qualify if you...
- History of allergic reactions to similar compounds
- Pregnant or breastfeeding women
- Active or suspected autoimmune disease, except certain controlled or non-recurring conditions
- Need for systemic corticosteroids (>10 mg prednisone daily) or immunosuppressants within 14 days before treatment
- History of interstitial lung disease or checkpoint inhibitor-induced pneumonitis
- Known HIV infection or AIDS
- Active hepatitis B or C infection unless fully treated and cleared
- Previous solid organ or allogeneic stem cell transplant
- Active infection requiring intravenous antibiotics or uncontrolled illness needing hospitalization
- Significant cardiovascular or cerebrovascular disease within 3 months, including prolonged QTc
- Unresolved adverse effects from prior cancer therapy greater than grade 1 (except specified conditions)
- Prior discontinuation of PD-1, PD-L1, or CTLA-4 inhibitors due to immune-related adverse events requiring systemic immunosuppression
- Use of other investigational agents
- Recent or planned use of live vaccines around study treatment
- Inadequate washout from prior therapies as specified
- Known progressing additional malignancies requiring active treatment (with some exceptions)
- Psychiatric or substance abuse disorders interfering with study compliance
- Inability to comply with study and follow-up procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
N
Natalie Vokes, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here