Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy

This pilot study is configured as a non-inferiority comparison of Performance Status 2 patients with Performance Status 0-1 patients, with the goal of demonstrating non-inferiority in terms of efficacy (progression-free survival, overall survival) and safety (rates of adverse events, quality of life) when treating Performance Status 2 patients with the same first-line immunotherapy-based regimen as Performance Status 0-1 patients.

Trial Details

NCT ID
NCT04253964
Phase
PHASE2
Sponsor
Wake Forest University Health Sciences
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • Pembrolizumab
  • Carboplatin
  • Paclitaxel
  • Nab paclitaxel
  • Quality of Life Questionnaire, lung cancer-specific (QLQ-LC13)
  • QLQ-C30 Global Health/Quality of Life Questionnaire
Locations (sample)
  • Winston-Salem, North Carolina, United States|36.09986,-80.24422

Key Eligibility Criteria

  • Patients must have a cytological or histological diagnosis of non-small cell lung cancer that is metastatic or unresectable for which standard cura…
  • No prior systemic treatment with either chemotherapy or immunotherapy for non-curative intent. Patients may have previously received cancer treatme…
  • At least 18 years old.
  • ECOG performance status of 0-2, as determined by the treating physician in the consult note.

For full eligibility, visit ClinicalTrials.gov.

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