NCT04023617

A Study of Nivolumab +/- Docetaxel in Patients Previously Treated With Advanced or Metastatic NSCLC

A Study of Nivolumab +/- Docetaxel in Patients Previously Treated With Advanced or Metastatic Non Small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Nivolumab and Docetaxel have been approved as standard second-line treatments for non-small cell lung cancer in several countries including China and the United States.

Conditions

• Carcinoma, Non-Small-Cell Lung
• Docetaxel
• Nivolumab

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab 300mg + docetaxel 75mg/m2 IV q3w Nivolumab 200mg IV q2w

Timeline

• Start date: 2019-07-08
• Primary completion: 2020-06-30
• Completion: 2021-05-30
• First posted: 2019-07-17
• Last updated: 2019-07-17

Locations

1 site across 1 country: China