Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)

Recruiting now · Phase 2

Conditions studied: Non-Small Cell Lung Cancer, NSCLC, Advanced Non-Small Cell Lung Cancer, Metastatic Non Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT06731413

Run by

Virginia Commonwealth University

People needed

40

Starts

2025-02-11

Expected to finish

2033-07-30

Last updated by the study team

2026-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Virginia Commonwealth University — Richmond, Virginia, United States (enrolling)
• VCU Health Tappahannock Hospital — Tappahannock, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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