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Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 15, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07874490). This is a study registration, not published results. Lead sponsor: NYU Langone Health. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 60 participants (ESTIMATED). Conditions: Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor. Interventions: DRUG: Osimertinib; DRUG: Cyclosporine A (CsA); DEVICE: ctDNA Biopsy Panel. Primary outcome measures: Proportion of Patients Achieving Complete Clearance of Plasma EGFR Mutations , Up to Year 2. Brief summary: This single-site, biomarker-enriched, randomized Phase II study will evaluate osimertinib with or without cyclosporine A (CsA) in metastatic epidermal growth factor receptor (EGFR )-mutant non-small cell lung cancer (NSCLC) \[exon 19 deletion or L858R\]. All consented, baseline circulating tumor DNA (ctDNA)-positive patients receive a 3-week osimertinib run-in; those with persistent ctDNA ("shedders") are randomized 1:1 to continue osimertinib or osimertinib+CsA. Plasma is collected approximately every 3 weeks in both arms for molecular response monitoring. The investigators plan to enroll 60 patients with approximately 40 "shedders" randomized with 20 enrolled in each arm. All patients will be treated with osimertinib daily throughout the study; the combination of osimertinib+CsA will receive CsA. Imaging will be performed as per standard of care.