Recruiting
Phase 2

Pembrolizumab

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT05589818

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pembrolizumab

Study Details

Brief summary:

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.

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Study ID

NCT05589818

Start date

Dec 5, 2023

Status verified date

Jun, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

45 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pembrolizumab

Patients will be treated with the standard dose of pembrolizumab (200mg IV every 3 weeks) for the first 12 weeks of the study. After week 12 assessments, patients without objective progression of disease are eligible to transition to Q6W dosing of pembrolizumab 400mg IV.

Interventions

Pembrolizumab

Patients will be treated with the standard dose of pembrolizumab for the first 12 weeks of the study. After week 12 assessments, patients without objective progression of disease are eligible to transition to Q6W dosing of pembrolizumab 400mg IV. Patients will be offered this schedule, also an FDA-approved option, at the discretion of the treating physician, based on tolerability of the q3week regimen and clinician assessment of need for closer follow up intervals. Pembrolizumab will be continued until disease progression, unacceptable toxicity, withdrawal of consent, or death.

Primary outcome measure

  • Change in EORTC QLQ-C30 Quality of Life score [ Time Frame: Baseline and 12 weeks post-treatment ]

Central Contacts and Locations

Central contacts

Deborah Doroshow, MD, PhD

212-241-5615deborah.doroshow@mssm.edu

Bailey Fitzgerald, MD

Bailey.Fitzgerald@mountsinai.org

Locations

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Katherine Vandris

Katherine.Vandris@mssm.edu

Bailey Fitzgerald, MD

Bailey.Fitzgerald@mountsinai.org

Principal Investigator:

Deborah Doroshow

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-06-15.