drugset / Trial / NCT04253964
Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy
Phase 2
Recruiting
105 enrolled
Wake Forest University Health Sciences
National Cancer Institute (NCI) · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2020-07-01
- Primary completion
- 2026-09
- Completion
- 2026-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Subject | Nab-paclitaxel | Small molecule | 100 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |