Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)
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.
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This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jun 2, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Virginia Commonwealth University
- Interventions being studied
- Drug: Reduced Dose of Chemotherapy and Immunotherapy
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) (either squamous or non- squamous)
- Stage IIIB, IIIC or IV disease OR have recurrent disease and not be candidates for curative treatment such as combined chemo-radiation
- No previous line of treatment in the recurrent or metastatic setting. Neoadjuvant or adjuvant treatment more than 6 months before enrollment is acceptable.
- Age 70 or meeting frailty definition or above at the date of signing informed consent
- Absence of driver mutations that have first line Food and Drug Administration (FDA) approved targeted therapy (biomarker testing is optional for squamous cell)
- PD-L1 tumor proportion score (TPS) of less than 50%
- Eastern Cooperative Oncology Group (ECOG) PS of 0-3
- Have measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment
- Absolute neutrophil count (ANC) ≥ 1,000/μL
- Platelets ≥ 75,000/μL
- Hemoglobin (Hgb) ≥ 8.0 g/dL (transfusion permitted)
- Total bilirubin ≤ 2 x institutional upper limit of normal (ULN)
- Aspartate amino transferase (AST)serum glutamic-oxaloacetic transaminase (SGOT) /alanine aminotransferase (ALT)serum glutamic-pyruvic transaminase (SGPT) ≤ 5.0 × institutional ULN
- Ability to understand and the willingness to sign a written informed consent document
- Participants with life expectancy of less than 3 months at the time of enrollment
- Has active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, or immunosuppressive drugs)
- Diagnosis of interstitial lung disease
- Creatinine clearance of \<30 mL/min
- Symptomatic, untreated central nervous system (CNS) disease or leptomeningeal disease. Patients with asymptomatic or treated CNS disease are eligible
- Required ongoing use of immunosuppressive medication, including steroids, with the following allowable exceptions:
- Doses less than or equal to the equivalent of prednisone 10 mg daily
- Short courses of steroids that are discontinued prior to enrollment
- Inhaled, intranasal and/or topical steroids
- Dexamethasone taper for treating vasogenic edema associated with CNS disease
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Virginia Commonwealth UniversityRichmond, Virginia
- VCU Health Tappahannock HospitalTappahannock, Virginia
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 2, 2026. Always confirm current availability with the study team.