New York, NYNCT07874490Now EnrollingIRB Ready

Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor Clinical Trial in New York, NY

Access cutting-edge non-small cell lung cancer with mutation in epidermal growth factor receptor treatment through this phase 2 clinical trial at a research site in New York. Study-provided care at no cost to qualified participants.

Sponsored by NYU Langone Health

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related non-small cell lung cancer with mutation in epidermal growth factor receptor treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to New York

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit New York site if eligible
  4. 4Begin participation

About This Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor Study in New York

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.

Sponsor: NYU Langone Health

Who Can Participate

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).

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT07874490) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor Treatment Options in New York, NY

If you're searching for non-small cell lung cancer with mutation in epidermal growth factor receptor treatment options in New York, NY, this clinical trial (NCT07874490) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced non-small cell lung cancer with mutation in epidermal growth factor receptor specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all non-small cell lung cancer with mutation in epidermal growth factor receptor clinical trials near you to find additional studies recruiting in your area.

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