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Pembrolizumab for Advanced Non-Small Cell Lung Cancer (NSCLC) with ECOG PS 2-3

This study is testing pembrolizumab, an immunotherapy drug, for people with advanced non-small cell lung cancer (NSCLC) who are not able to have surgery or standard chemotherapy/radiation. You might be eligible if your tumor has a PD-L1 level of 1% or higher and your ECOG performance status (a measure of how well you can perform daily activities) is 2 or 3. The study will look at how pembrolizumab affects your quality of life after 12 weeks of treatment. Patients will receive pembrolizumab every 3 weeks, and if your disease doesn't worsen after 12 weeks, you may switch to receiving it every 6 weeks. This trial is currently unclear about its status and aims to enroll 45 participants.

Study design
This is a single-arm, open-label study, meaning all participants will receive pembrolizumab, and both you and the study team will know what treatment you are getting. It plans to enroll 45 participants.
What's involved
You will receive pembrolizumab intravenously (IV) every 3 weeks for the first 12 weeks, with assessments at baseline and 12 weeks. If your disease doesn't progress, you may then receive pembrolizumab every 6 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your quality of life will be assessed at baseline and 12 weeks after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05589818

Pembrolizumab for Advanced NSCLC and PS 2-3

Recruiting
PHASE2Ages 18+InterventionalTreatment
Icahn School of Medicine at Mount Sinai
~45 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:Pembrolizumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in EORTC QLQ-C30 Quality of Life score
Measured over Baseline and 12 weeks post-treatment

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Deborah Doroshow, MD, PhD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
  • Bailey Fitzgerald, MD · STUDY_DIRECTOR · Icahn School of Medicine at Mount Sinai

Who to contact

Deborah Doroshow, MD, PhD
[email protected]
212-241-5615
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in EORTC QLQ-C30 Quality of Life scoreBaseline and 12 weeks post-treatment

    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.