Phase
Condition
Non-small Cell Lung Cancer
Treatment
Reduced Dose of Chemotherapy and Immunotherapy
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) (either squamous or non- squamous)
Stage IV disease OR have recurrent disease and not be candidates for curativetreatment such as combined chemo-radiation
No previous line of treatment in the recurrent or metastatic setting. Neoadjuvant oradjuvant treatment more than 6 months before enrollment is acceptable.
Age 70 or meeting frailty definition or above at the date of signing informedconsent
Absence of driver mutations that have first line Food and Drug Administration (FDA)approved targeted therapy
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 siteinvestigator/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 consentdocument
Exclusion
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 leptomeningealdisease. Patients with asymptomatic or treated CNS disease are eligible
Required ongoing use of immunosuppressive medication, including steroids, with thefollowing 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
Study Design
Study Description
Connect with a study center
Virginia Commonwealth University
Richmond, Virginia 23298
United StatesActive - Recruiting
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