Actively Recruiting
Pembrolizumab for Advanced NSCLC and PS 2-3
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-06-25
45
Participants Needed
1
Research Sites
257 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Pembrolizumab for Advanced NSCLC and PS 2-3
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 years and older with locally advanced or metastatic NSCLC who are ineligible for surgery or chemoradiation
- No prior systemic therapy for metastatic cancer
- No prior treatment with PD-1 or PD-L1 inhibitors
- ECOG performance status of 2 or 3 at consent and first day of therapy
- No molecular alterations with approved first-line targeted therapies (ALK, ROS1, EGFR, BRAF, NTRK, RET, MET, etc.)
- Patients with treated brain metastases stable for at least 4 weeks
- Patients with new or progressive brain metastases if immediate CNS therapy is not required
- Patients with HIV on effective therapy and undetectable viral load within 6 months
- Adequate organ and marrow function as defined by specified blood counts and kidney/liver function
- Women of childbearing potential must have negative pregnancy test within 3 days before treatment
- Signed informed consent
- Ability to take study medication and complete questionnaires
- Willingness to comply with study procedures
- Use of effective contraception during treatment and for 4 months after final dose (both women and men)
You will not qualify if you...
- Autoimmune conditions requiring more than 10 mg prednisone daily or other systemic immunosuppressive therapy
- Receiving other investigational agents
- Uncontrolled illnesses such as active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social conditions limiting compliance
- Known leptomeningeal disease requiring CNS therapy
- Pregnant or breastfeeding patients
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
Research Team
D
Deborah Doroshow, MD, PhD
CONTACT
B
Bailey Fitzgerald, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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