Actively Recruiting
Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)
Led by Virginia Commonwealth University · Updated on 2026-03-13
40
Participants Needed
1
Research Sites
441 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluate frequency of adverse events that lead to chemotherapy discontinuation in vulnerable older adults with recurrent/metastatic PD-L1 TPS\<50% NSCLC patients who receive reduced dose chemotherapy in combination with immunotherapy.
CONDITIONS
Official Title
Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC), squamous or non-squamous
- Stage IIIB, IIIC, or IV disease, or recurrent disease not suitable for curative treatment
- No prior treatment for recurrent or metastatic NSCLC; prior neoadjuvant or adjuvant therapy allowed if completed over 6 months ago
- Age 70 or older, or meeting frailty definition at consent
- No driver mutations for which FDA-approved targeted therapy is available (biomarker testing optional for squamous cell)
- PD-L1 tumor proportion score less than 50%
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3
- Measurable disease per RECIST 1.1 as assessed locally
- Absolute neutrophil count of at least 1,000/µL
- Platelet count of at least 75,000/µL
- Hemoglobin level of at least 8.0 g/dL (transfusions allowed)
- Total bilirubin no greater than twice the institutional upper limit of normal
- AST (SGOT) and ALT (SGPT) levels no greater than 5 times the institutional upper limit of normal
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Life expectancy less than 3 months at enrollment
- Active autoimmune disease requiring systemic treatment in past 2 years
- Diagnosis of interstitial lung disease
- Creatinine clearance less than 30 mL/min
- Symptomatic or untreated central nervous system disease or leptomeningeal disease
- Ongoing immunosuppressive medication use, except:
- Prednisone 10 mg daily or less
- Short steroid courses stopped prior to enrollment
- Inhaled, intranasal, or topical steroids
- Dexamethasone taper for CNS disease-related vasogenic edema
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
M
Massey IIT Research Operations
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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