Osimertinib and Cyclosporine A to Enhance Antitumor Efficacy in NSCLC

Conditions

• Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Osimertinib — DRUG
  80 mg by mouth daily
• Cyclosporine A (CsA) — DRUG
  1.5 mg/kg by mouth twice daily
• ctDNA Biopsy Panel — DEVICE
  Panel repeated every 3 weeks.

Study Details

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.

Key Dates

First listed

Oct 15, 2026

Start date

Oct 31, 2026

Status verified

Oct 2026

Primary completion

Dec 31, 2030

Completion

Dec 31, 2033

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Osimertinib
  Following a 3-week osimertinib run-in; patients continue to receive osimertinib for the duration of the study. ctDNA tests will be repeated every 3 weeks.
• Experimental: Osimertinib + Cyclosporine A (CsA)
  Following a 3-week osimertinib run-in; patients receive osimertinib and CsA for the duration of the study. ctDNA tests will be repeated every 3 weeks.

Primary Outcome Measure

Proportion of Patients Achieving Complete Clearance of Plasma EGFR Mutations [ Time Frame: Up to Year 2 ]

Central Contacts

• Elaine Shum, MD
  212-731-5662
  [email protected]

Locations (1)

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