OncoMatch/Clinical Trials/NCT07133425
A Phase 2 Platform Study of Immunomodulatory Compounds in ICI-refractory Non-small Cell Lung Cancer
Is NCT07133425 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies SAR445877 for non-small cell lung cancer.
Treatment: SAR445877 — To learn if SAR445877 can help to control locally advanced or metastatic NSCLC in patients who have previously received ICI therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Disease stage
Metastatic disease required
locally advanced or metastatic NSCLC
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1/PD-L1 therapy — metastatic
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. Treatment with neoadjuvant or adjuvant ICI is acceptable if participant developed progression within one year of start of ICI therapy.
Lab requirements
Blood counts
Hemoglobin >9.0 g/dL; Absolute neutrophil count ≥1000/mcL; Platelets ≥75,000/mcL
Kidney function
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).
Liver function
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.
Cardiac function
Significant cardiovascular/cerebrovascular disease, including stroke, myocardial infarction, or prolonged QTc (> 480msec) within 3 months [excluded]. Participants on beta blockers must be able to stop beta blockers for duration of their time on study treatment period when applicable.
Adequate organ and marrow function as defined below, obtained before study treatment initiation: 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. For participants receiving therapeutic anticoagulation: stable anticoagulant regimen.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MD Anderson Cancer Center · Houston, Texas
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