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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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
Are there results?: Not yet: the study is under way

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.

Elaine Shum, MD contact

212-731-5662

CancerTrials@nyulangone.org

United States1 site, 1 recruiting

NYU Langone Heath
New York, New York, 10016
Recruiting

Other trials in United States

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.

Conditions: Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor
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 groups in NCT07874490
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.

Oct 2026Dec 2033

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)

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.

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT07874490
Acronym / sponsor ID: OCEAN / 26-00372
Conditions: Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor
Keywords: NSCLC, Non-Small Cell Lung Cancer, osimertinib, cyclosporine A, CsA
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 60 participants (estimated)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Study start: Oct 2026 (estimated)
Primary completion: Dec 2030 (estimated)
Study completion: Dec 2033 (estimated)
First posted: 15 Oct 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Osimertinib	Active comparator	Drug: Osimertinib, Device: ctDNA Biopsy PanelFollowing 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.
Osimertinib + Cyclosporine A (CsA)	Experimental	Drug: Osimertinib, Drug: Cyclosporine A (CsA), Device: ctDNA Biopsy PanelFollowing 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Osimertinib80 mg by mouth daily	Drug	Osimertinib, Osimertinib + Cyclosporine A (CsA)
Cyclosporine A (CsA)1.5 mg/kg by mouth twice daily	Drug	Osimertinib + Cyclosporine A (CsA)
ctDNA Biopsy PanelPanel repeated every 3 weeks.	Device	Osimertinib, Osimertinib + Cyclosporine A (CsA)

Primary outcome

Proportion of Patients Achieving Complete Clearance of Plasma EGFR Mutations
Time frame: Up to Year 2
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).

3 secondary outcomes

Overall Response Rate (ORR)
Time frame: Up to Year 2
Progression-Free Survival (PFS)
Time frame: Up to Year 2
Overall Survival (OS)
Time frame: Up to Year 2

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Elaine Shum, MD contact

212-731-5662

CancerTrials@nyulangone.org

Elaine Shum, MD principal investigator

NYU Langone Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elaine Shum, MD (212-731-5662, CancerTrials@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients Achieving Complete Clearance of Plasma EGFR Mutations (time frame: Up to Year 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07874490.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.