Actively Recruiting
Study of Pembrolizumab and Single Agent Chemotherapy as First Line Treatment for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer With Eastern Cooperative Oncology Group (ECOG) Performance Status of 2
Led by University of Rochester · Updated on 2026-02-09
28
Participants Needed
2
Research Sites
402 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to understand if treatment with one chemotherapy medication combined with immune therapy (pembrolizumab) is tolerable and effective for patients with lung cancer and performance status of 2 (PS2), which means you have limitations in carrying out certain activities or spend up to half of your day resting.
CONDITIONS
Official Title
Study of Pembrolizumab and Single Agent Chemotherapy as First Line Treatment for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer With Eastern Cooperative Oncology Group (ECOG) Performance Status of 2
Who Can Participate
Eligibility Criteria
You may qualify if you...
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Participants must be over 18 years old at time of diagnosis
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Histologically confirmed non-small cell lung cancer
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Eastern Cooperative Oncology Group Performance Status of 2
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Clinical stage IIIc or IV disease
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For stage IIIc, patients are ineligible for or refuse standard platinum-double chemotherapy and radiation
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For stage IV, platinum doublet chemotherapy is unsuitable, unsafe, or declined
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Screening labs must meet: absolute neutrophil count
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AST and ALT less than or equal to 2.5 times the upper limit of normal
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Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after treatment
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Patients with small, asymptomatic brain metastases are eligible
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Participants must be able to read or have the study purpose explained and sign informed consent
You will not qualify if you...
- History of autoimmune conditions except alopecia, vitiligo, rheumatoid arthritis, psoriasis/psoriatic arthritis, or Hashimoto's thyroiditis
- Use of immunosuppressive medication exceeding prednisone 10 mg daily equivalent (short courses stopped before treatment allowed)
- Cardiovascular, liver, or kidney diseases preventing chemotherapy or immunotherapy use per doctor
- Participation in other clinical trials involving experimental therapies during this study
- Currently pregnant or breastfeeding women
- Other medical or psychiatric conditions deemed unsuitable by the investigator
- Symptomatic untreated brain metastases; treated brain metastases allowed after radiation and steroid tapering
- Active infection requiring intravenous antibiotics
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of Rochester
Rochester, New York, United States, 14642
Not Yet Recruiting
2
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
Research Team
M
Megan Baumgart
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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