A Study of Nivolumab +/- Docetaxel in Patients Previously Treated With Advanced or Metastatic NSCLC
Status:
Unknown status
Trial end date:
2021-05-30
Target enrollment:
Participant gender:
Summary
This study is a randomized, single-center, open-label, phase II clinical trial designed to
evaluate non-small cell lung cancer that has failed to undergo excessive platinum-based
chemotherapy and has not received excessive statin chemotherapy and has not received
immunotherapy. The efficacy and safety of Nivolumab in combination with docetaxel and
Nivolumab in patients.
Qualified patients were stratified by histological type (squamous cell carcinoma vs.
non-squamous cell carcinoma) randomized to receive the following regimen in a 1:1 ratio:
Group A: Nivolumab 300mg + docetaxel 75mg/m2 IV q3w Group B: Nivolumab 200mg IV q2w All
patients were evaluated for tumor at baseline, and tumor evaluations were performed every 6
weeks within 48 weeks after randomization (regardless of whether dosing was delayed). After
the 48th week of assessment, a tumor assessment is required every 9 weeks until disease
progression, withdrawal of informed consent, sponsor termination study, or patient death.