RecruitingPhase 2

Osimertinib and Cyclosporine A to Enhance Antitumor Efficacy in NSCLC

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding cyclosporine A to osimertinib works better against non-small cell lung cancer that has spread and has certain EGFR gene changes. Patients must have tumor DNA in their blood at the start. After 3 weeks of osimertinib, those who still have tumor DNA in their blood are assigned by chance to continue osimertinib alone or add cyclosporine A.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older and able to agree to join the study.
  • Have non-small cell lung cancer that has spread, proven by a biopsy and confirmed at NYU Langone Health.
  • Have an EGFR exon 19 deletion or L858R gene change found by standard testing.
  • Have not started an EGFR-targeted drug, or started osimertinib within the allowed 3-week window with study doctor approval. No past chemotherapy for cancer that has spread; treatment after surgery more than 6 months earlier is allowed.
  • Have a tumor that can be measured and has not been treated with radiation. If already taking osimertinib, tumor measurements from before treatment must be available.
  • Be able to care for yourself and be out of bed or a chair for at least half the day (ECOG score 0–2).
  • Have organs that work well enough for treatment.
  • Use highly effective birth control if you or your female sexual partner could become pregnant.

Who can't join

  • Are pregnant or breastfeeding.
  • Had radiation within 1 week or major surgery within 2 weeks before study treatment. These waiting periods do not apply if you have already started osimertinib.
  • Recently took an experimental drug: the wait must be at least 3 months or the time for five half-lives of the drug, whichever is longer. Cannot stop medicines or herbs that strongly increase CYP3A4, a substance that helps the body break down drugs.
  • Have a severe or uncontrolled illness, such as uncontrolled high blood pressure or a bleeding disorder; or an active infection, including hepatitis B, hepatitis C, or HIV.
  • Have ongoing nausea, vomiting, bowel disease, trouble swallowing pills, or past bowel surgery that would keep your body from taking in the study drugs.
  • Have certain heart rhythm or electrical problems, including a QTc over 470 milliseconds, or factors that raise the risk of a dangerous heartbeat. These include heart failure, low blood minerals, certain family histories, or certain medicines.
  • Have current or past interstitial lung disease (inflammation or scarring in the lungs), including lung disease caused by drugs, or lung inflammation from radiation that needed steroids.
  • Have an allergy to either study drug, its ingredients, or similar drugs; or a history of autoimmune disease, where the immune system attacks the body. Hashimoto’s thyroiditis is allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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. * 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).

Study sites (1)

NY