RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Osimertinib for Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor

This single-site, biomarker-enriched, randomly assigned 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 randomly assigned 1:1 to continue osimertinib or osimertinib+CsA.

Official registry: https://clinicaltrials.gov/study/NCT07874490 · NYU Langone Health · enrollment listed as 60

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Osimertinib, Cyclosporine A (CsA), or ctDNA Biopsy Panel. The registry lists allocation as randomized. This single-site, biomarker-enriched, randomly assigned 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) \[exon 19 deletion or L858R\].

They plan to enroll about 60 people at New York. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.

Official title (unrewritten)

The OCEAN Trial: A Phase II Study of Osimertinib and Cyclosporine to Enhance Antitumor Efficacy in EGFR-Mutant Non-Small Cell Lung Cancer

Interventions: Osimertinib, Cyclosporine A (CsA), ctDNA Biopsy Panel

Primary outcome (registry wording): Proportion of Patients Achieving Complete Clearance of Plasma EGFR Mutations

Who it is for (from inclusion criteria)

Ages 18 Years to any
Standard of care (SOC) biopsy-proven metastatic non-small cell lung cancer, confirmed at NYU Langone Health (NYULH)
Somatic activating mutation in EGFR exon 19 deletion or EGFR L858R in pre-treatment tumor biopsy or cytology from pleural fluid or cfDNA as detected by SOC testing
how well you can do daily activities (ECOG score) of 0-2
Adequate organ function
Willing to use highly effective contraceptive measures if of child-bearing potential or if the patient's sexual partner is a woman of child-bearing potential

Who the registry excludes

Pregnant or lactating women
Any major surgery within 2 weeks of starting treatment on protocol. The washout window only applies for patients who have not started Osimertinib
Treatment with an investigational drug within five half-lives of the compound or 3 months, whichever is greater
Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial
Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required
Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the tablets or previous significant bowel resection that would preclude adequate absorption of Osimertinib or cyclosporine A
Mean resting corrected QT interval (QTcF) \> 470 msec

Public study contact (from the registry)

Elaine Shum, MD

212-731-5662

CancerTrials@nyulangone.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

NYU Langone Heath — New York, New York (recruiting)

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FAQ about this NCT record

Is NCT07874490 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07874490?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07874490?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary