NCT02766140

SHR1020 Plus Docetaxel as Compared to Placebo Plus Docetaxel in 2nd Line Non Squamous Non Small Cell Lung Cancer

Multicentre, Randomised, Double-blind, Phase III Trial to Investigate the Efficacy and Safety of Oral SHR1020 Plus Docetaxel Therapy Compared to Placebo Plus Docetaxel Therapy in Patients With Local Advanced or Metastatic or Recurrent Non Squamous Non Small Cell Lung Cancer After Failure of First Line Chemotherapy.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The present trial will be performed to evaluate whether SHR1020 in combination with docetaxel in patients with Local Advanced or Metastatic or recurrent Non Squamous NSCLC is more effective as compared to placebo in combination with docetaxel. A secondary aim is to obtain safety information as well as information on quality of life of patients treated with SHR1020 in combination with docetaxel.

Conditions

• Non Squamous Non Small Cell Lung

Interventions

Type	Name	Description
DRUG	SHR1020 plus Docetaxel	SHR1020 20mg qd 2-21days, Docetaxel 60 mg/m\^2 IV Day1/3weeks
DRUG	Placebo plus Docetaxel	Placebo matching SHR1020 qd 2-21days, Docetaxel 60 mg/m\^2 IV Day1/3weeks

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2016-05-09
• Last updated: 2019-01-18

Locations

1 site across 1 country: China