A Study of LY01008 and Bevacizumab Combined With Paclitaxel and Carboplatin for Treatment of Naïve Subjects With Metastatic or Recurrent Nonsquamous Non-small Cell Lung Cancer

Sponsor
Luye Pharma Group Ltd.
Study ID
NCT03533127
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • LY01008 — DRUG
    LY01008+Carboplatin/Paclitaxel
  • Bevacizumab — DRUG
    Bevacizumab + Carboplatin/Paclitaxel

Study Details

This is a Randomized, Double-blind, Multicenter Phase III Study Comparing Efficacy and Safety of LY01008 (Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection) and Bevacizumab Combined with Paclitaxel and Carboplatin for Treatment of Naïve Subjects with Metastatic or Recurrent Nonsquamous Non-small Cell Lung Cancer

Key Dates

First listed
May 22, 2018
Start date
Nov 27, 2017
Status verified
Jul 2018
Primary completion
Jun 28, 2020
Completion
Dec 28, 2020

Study Design

Enrollment
648 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LY01008+Carboplatin/Paclitaxel
    Drug: LY01008 15 mg/kg IV every 3 weeks on Day 1 Drug: Carboplatin Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Drug: Paclitaxel Paclitaxel 175 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles
  • Experimental: Bevacizumab + Carboplatin/Paclitaxel
    Drug: Bevacizumab Bevacizumab 15 mg/kg IV every 3 weeks on Day 1 Drug: Carboplatin Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Drug: Paclitaxel Paclitaxel 175 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles

Primary Outcome Measure

Best Objective Response Rate [ Time Frame: 19 weeks from randomization ]

Central Contacts

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