Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)
Phase 2 Study to Evaluate Reduced Dose Chemotherapy in Combination With Anti-PD-1 Therapy as First Line Treatment in Vulnerable or Older Adults (Vulnerable or Age ≥70) With Advanced PD-L1 TPS <50% Non-small Cell Lung Cancer
Virginia Commonwealth University
40 participants
Feb 11, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria14
- 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 Criteria10
- 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
Interventions
Eligible participants with recurrent or metastatic squamous cell carcinoma will receive 4 cycles of carboplatin area under the curve (AUC) 3 IV every 21 days and paclitaxel 135 mg/m2 intravenous (IV) every 21 days. Participants with non-squamous histology will receive carboplatin AUC 3 IV every 21 days and pemetrexed 375 mg/m2 IV every 21 days (collectively, induction chemotherapy). Both groups will receive pembrolizumab 200 mg IV every 21 days for a total of up to 35 cycles (Cycles ≥5 are collectively the maintenance portion of treatment) or until disease progression or unacceptable toxicity.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06731413