Clinical Trials Directory

Trials / Completed

CompletedNCT02954172

Evaluate the Efficacy and Safety of IBI305 in Patients With Advanced or Recurrent Non-squamous NSCLC

Study to Evaluate the Efficacy and Safety of IBI305 in Combination With Paclitaxel/Carboplatin Versus Bevacizumab in Combination With Paclitaxel/Carboplatin in Treatment-naïve Patients With Advanced or Recurrent Non-squamous NSCLC

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
450 (actual)
Sponsor
Innovent Biologics (Suzhou) Co. Ltd. · Industry
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

A randomized, double blind, multicenter phase3 study .

Detailed description

A randomized, double blind, multicenter phase3 study in chemotherapy naive patients with stage IIIB,IV or recurrent NSCLC of non-squamous. the study will randomize about 436 patients at a 1:1 ratio to 2 treatment arms. The study is divided 4 phase, screening, combination treatment, maintenance and follow up.

Conditions

Interventions

TypeNameDescription
DRUGBevacizumab in Combination With Paclitaxel/CarboplatinDrug Bevacizumab15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
DRUGIBI305 in Combination with Paclitaxel/CarboplatinDrug IBI305 15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg

Timeline

Start date
2016-11-28
Primary completion
2018-10-19
Completion
2019-11-12
First posted
2016-11-03
Last updated
2020-12-08
Results posted
2020-12-08

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT02954172. Inclusion in this directory is not an endorsement.