A Study of ABP 215 Versus Bevacizumab in Chinese Subjects With Advanced Non-Squamous Non-Small Cell Lung Cancer

Sponsor
Amgen
Study ID
NCT04466917
Phase
PHASE3
Status
Withdrawn

Conditions

  • Metastatic Non-small Cell Lung Cancer (NSCLC)
  • Non-squamous NSCLC

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • ABP 215 — DRUG
    ABP 215 will be administered at a dose of 15 mg/kg IV
  • Bevacizumab — DRUG
    Bevacizumab will be administered at a dose of 15 mg/kg IV
  • Paclitaxel — DRUG
    Paclitaxel will be administered 175 mg/m2 IV
  • Carboplatin — DRUG
    Carboplatin will be administered at an area under the concentration-time curve (AUC) of 5 IV

Study Details

The purpose of this research study is to assess the efficacy and safety of ABP 215 compared to Bevacizumab in Chinese patients with advanced non-small cell lung cancer (NSCLC).

Key Dates

First listed
Jul 10, 2020
Start date
May 15, 2021
Status verified
May 2021
Primary completion
Nov 13, 2022
Completion
Nov 13, 2022

Study Design

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

Arms

  • Experimental: ABP 215
    Subjects will be randomized to receive ABP 215 every 3 weeks (Q3W) for 6 cycles. All subjects will receive carboplatin and paclitaxel after the ABP 215 IV infusion every Q3W for at least 4 and not more than for 6 cycles.
  • Active Comparator: Bevacizumab
    Subjects will be randomized to receive Bevacizumab every 3 weeks (Q3W) for 6 cycles. All subjects will receive carboplatin and paclitaxel after the Bevacizumab IV infusion every Q3W for at least 4 and not more than for 6 cycles.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: From Day 1 to Week 19 (EOS) ]

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