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 · NCT06731413 · Interventional (participants receive a specific treatment) · Lead sponsor: Virginia Commonwealth University
View the official record on ClinicalTrials.gov →Interventions studied
Reduced Dose of Chemotherapy and Immunotherapy
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
2 locations listed across 1 US state.
- Virginia Commonwealth University - Richmond, Virginia, United States
- VCU Health Tappahannock Hospital - Tappahannock, Virginia, United States