Is NCT05589818 recruiting in New York, NY?

Yes, NCT05589818 is currently recruiting participants at its New York, NY location. This non-small cell lung cancer (nsclc) clinical trial is actively enrolling qualified participants.

How do I join the non-small cell lung cancer (nsclc) clinical trial in New York?

To join this clinical trial in New York, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this New York clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Non-Small Cell Lung Cancer (NSCLC) Clinical Trial in New York, NY

About This Non-Small Cell Lung Cancer (NSCLC) Study in New York

This single center open-label trial will enroll a single cohort of patients with advanced non-small cell lung cancer (NSCLC) who are ineligible for treatment with curative intent due to 1) disease stage IV, or 2) inability to tolerate intensive surgery or chemo-radiation. Patients will be eligible for the trial if ISMMS reviewed samples from tumor biopsy have a PDL-1 TPS ≥ 1% and have ECOG performance status rated 2 or 3. All patients will receive anti PD-1 therapy with pembrolizumab 200mg IV every 3 weeks, during which patients will also undergo serial QOL assessments. This trial will follow a phase II single arm, open label design. The study will enroll 45 patients evaluable for the primary endpoint of which will be change in QOL as measured by the EORTC's QLQ-C30 between Day 1 and Day 84 +/- 7 days. Secondary outcomes including evaluation for development of confounding mental health conditions will be evaluated via serial HADS assessments. Concomitant radiographic assessment with PET/CT, regardless of the doses of pembrolizumab received, will allow for evaluation of secondary efficacy outcomes, including disease response by RECIST 1.1 criteria.

Sponsor: Icahn School of Medicine at Mount Sinai

Who Can Participate

Inclusion Criteria

Men and women, aged 18 years and older, with locally advanced NSCLC who are ineligible for definitive surgical resection or concurrent chemoradiation, or metastatic NSCLC

Patients must not have received any systemic therapy for metastatic cancer

Patients must not have received any PD-1 or PD-L1 inhibitor

ECOG performance status of 2 or 3 at the time of consent and on the first day of therapy

Patients may not have a molecular alteration in ALK, ROS1, EGFR, BRAF, NTRK, RET, MET, or any other gene for which first-line FDA approved targeted therapy exists.

Patients with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period.

Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS directed therapy is not required and is unlikely to be required during the first cycle of therapy.

Patients with HIV on effective anti-retroviral therapy with an undetectable viral load within 6 months are eligible for this trial.

Adequate organ and marrow function as defined below:

Leukocytes ≥ 3,000/mcL

Absolute neutrophil count ≥ 1,000/mcL

Platelets ≥ 100,000/mcl

Total bilirubin ≤ 1.5 x ULN

AST (SGOT)/ALT (SPGT) ≤ 3 x ULN or ≤5 x ULN if liver metastases present

GFR (Cockroft-Gault) ≥ 30 mL/min

Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 3 days prior to C1D1 of pembrolizumab therapy. For the purposes of this trial, WOCBP are defined as women who have had a menstrual period within the last 48 months.

Provision of signed and dated informed consent form

Ability to take the study medication, and complete the study questionnaires

Stated willingness to comply with all study procedures for the duration of the study

For women of reproductive potential, agreement to use highly effective contraception during study treatment and for at least 4 months after the final dose

For men of reproductive potential, agreement to use condoms or other methods to ensure effective contraception with female partners of reproductive potential

Exclusion Criteria

Autoimmune conditions requiring \>10mg prednisone (or its equivalent) of daily therapy or other systemic immunosuppressive therapy.

Patients who are receiving other investigational agents

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Patients with known leptomeningeal disease for which CNS therapy is required

Pregnant or lactating patients

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 (NCT05589818) 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 (NSCLC) Treatment Options in New York, NY

If you're searching for non-small cell lung cancer (nsclc) treatment options in New York, NY, this clinical trial (NCT05589818) 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 clinical trial. You'll receive care from experienced non-small cell lung cancer (nsclc) 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 (nsclc) clinical trials near you to find additional studies recruiting in your area.

Non-Small Cell Lung Cancer (NSCLC) Clinical Trial in New York, NY

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