Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor ReceptorPhase 2OCEANNCT07874490
Osimertinib and Cyclosporine A to Enhance Antitumor Efficacy in NSCLC
A Phase 2 study testing Osimertinib, Cyclosporine A (CsA) and ctDNA Biopsy Panel in people with Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor, run by NYU Langone Health at 1 site in United States.
Trial 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]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor
- What is being tested?
- Osimertinib, Cyclosporine A (CsA) and ctDNA Biopsy Panel
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Dec 2033
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18 years, able to give informed consent.
- 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.
- Either have not started a prior EGFR TKI therapy, or may have started osimertinib within 3 weeks of confirming eligibility and enrollment criteria of measurable disease per approval of PI, with no prior chemotherapy for treatment of metastatic disease (adjuvant therapy > 6 months prior to study start is acceptable).
- Measurable (RECIST 1.1) indicator lesion not previously irradiated, with measurable disease determined per treating investigator. If a patient has already started on osimertinib there must be available pre-osimertinib baseline tumor assessments, to be utilized for RECIST 1.1 assessment.
- ECOG performance status 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 cannot join
- Pregnant or lactating women
- Any radiotherapy within 1 week prior to starting treatment on protocol. The washout window only applies for patients who have not started Osimertinib. No washout window needed if the patients started on Osimertinib. They should continue on Osimertinib. If patients received radiation prior to Osimertinib, they should wait for 7 days from the last day of radiation to start Osimertinib. If patients are already on osimertinib at the time of initial consent and they happened to also have radiation prior to starting on osimertinib, they do not need a washout in order to meet eligibility criteria for the study.
- 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.
- Currently receiving (or unable to stop prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4. All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4.
- 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.
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- 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
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block and second degree heart block.
- Patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including: Serum/Plasma potassium <LLN, Serum/Plasma Magnesium <LLN; Serum/Plasma Calcium <LLN), congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval and cause Torsades de Pointes. If concomitant medication can not be discontinued, please notify and confirm with MSK PI prior to enrollment.
- Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
- History of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib.
- History of hypersensitivity to active or inactive excipients of cyclosporine A or drugs with a similar chemical structure or class to cyclosporine A.
- History of autoimmune disease (excluding Hashimoto's thyroiditis).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Heath
New York, New York, 10016
About this study
Official title: The OCEAN Trial: A Phase II Study of Osimertinib and Cyclosporine to Enhance Antitumor Efficacy in EGFR-Mutant Non-Small Cell Lung Cancer
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.
- Being tested
- Osimertinib, Cyclosporine A (CsA), ctDNA Biopsy Panel
- Keywords
- NSCLC, Non-Small Cell Lung Cancer, osimertinib, cyclosporine A, CsA
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsimertinibDrug
80 mg by mouth daily
Cyclosporine A (CsA)Drug
1.5 mg/kg by mouth twice daily
ctDNA Biopsy PanelDevice
Panel repeated every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Osimertinib | Active comparator | 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. Receives: Drug: Osimertinib; Device: ctDNA Biopsy Panel |
| Osimertinib + Cyclosporine A (CsA) | Experimental | 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. Receives: Drug: Osimertinib; Drug: Cyclosporine A (CsA); Device: ctDNA Biopsy Panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Achieving Complete Clearance of Plasma EGFR Mutations
The proportion of patients achieving complete clearance of plasma EGFR mutations at the first post-randomization assessment and confirmed in serial ctDNA monitoring at specified timepoints (every 3 weeks up to treatment discontinuation).
Measured: Up to Year 2
Secondary outcomes (3)
Overall Response Rate (ORR)
ORR based on RECIST 1.1 criteria; defined as the proportion of patients who achieve a Complete Response (CR) or a Partial Response (PR) as their best overall response.
Measured: Up to Year 2
Progression-Free Survival (PFS)
Measured as time from randomization to disease progression or death.
Measured: Up to Year 2
Overall Survival (OS)
Measured as time from randomization to death.
Measured: Up to Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor ReceptorStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elaine Shum, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874490
- Sponsor's protocol ID
- 26-00372
- Acronym
- OCEAN
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: CancerTrials@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.