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

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT02954172
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab in Combination With Paclitaxel/Carboplatin — DRUG
    Drug Bevacizumab15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
  • IBI305 in Combination with Paclitaxel/Carboplatin — DRUG
    Drug IBI305 15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg

Study Details

A randomized, double blind, multicenter phase3 study .

Key Dates

First listed
Nov 3, 2016
Start date
Nov 28, 2016
Status verified
Nov 2020
Primary completion
Oct 19, 2018
Completion
Nov 12, 2019

Study Design

Enrollment
450 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab in Combination With Paclitaxel/Carboplatin
    Drug Bevacizumab15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
  • Active Comparator: IBI305 in Combination with Paclitaxel/Carboplatin
    Drug IBI305 15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg

Primary Outcome Measure

Objective Response Rate [ Time Frame: 18 weeks ]

Related Studies