Pembrolizumab for Advanced NSCLC and PS 2-3

NCT05589818 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STUDY-22-01144
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• Change in EORTC QLQ-C30 Quality of Life score

  Change in quality of life (QOL) score at 12 weeks post-treatment compared to baseline with pembrolizumab as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The scale ranges from 1=very poor to 7 = excellent. The higher the score the better the quality of life.

  Baseline and 12 weeks post-treatment

Secondary Outcomes (15)

• Change in EORTC QLQ-C30 Quality of Life score

  Baseline and 6 weeks post-treatment

• Change in EORTC's QLQ-LC13 Quality of Life (QOL) score

  Baseline and 6 weeks post-treatment

• Change in EORTC's QLQ-LC13 Quality of Life (QOL) score

  Baseline and 12 weeks post-treatment

• Change in Hospital Anxiety and Depression Scale (HADS) Quality of Life (QOL) score

  Baseline and 6 weeks post-treatment

• Change in Hospital Anxiety and Depression Scale (HADS) Quality of Life (QOL) score

  Baseline and 12 weeks post-treatment

Study Arms (1)

Pembrolizumab

EXPERIMENTAL

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.

Drug: Pembrolizumab

Interventions

Pembrolizumab DRUG

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.

Also known as: PD-1

Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Deborah Doroshow, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Bailey Fitzgerald, MD

  Icahn School of Medicine at Mount Sinai

  STUDY DIRECTOR

Central Study Contacts

Deborah Doroshow, MD, PhD

CONTACT

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

Bailey Fitzgerald, MD

CONTACT

Bailey.Fitzgerald@mountsinai.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: Phase II, Interventional, Single-Center, Open-Label, Non-Comparative, Single Cohort, Single-Arm, Trial

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: October 21, 2022
• Study Start: May 26, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (Link to be included in the URL field below).

Locations

US (1)