Efficacy and Safety Study of ABP 215 Compared With Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer

Part of paid clinical trials in Bismarck, North Dakota.

Sponsor
Amgen
Study ID
NCT01966003
Phase
PHASE3
Status
Completed

Conditions

  • Non-small Cell Lung Cancer Metastatic

Eligibility Criteria

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

Interventions

  • Carboplatin — DRUG
    Administered at an area under the concentration-time curve (AUC) 6 by IV infusion Q3W
  • Paclitaxel — DRUG
    Administered 200 mg/m² IV Q3W
  • ABP 215 — DRUG
    Administered 15 mg/kg Q3W by IV infusion
  • Bevacizumab — DRUG
    Administered 15 mg/kg Q3W by IV infusion

Study Details

The purpose of this research study is to compare the effectiveness and safety of ABP 215 against bevacizumab in men and women with advanced non-small cell lung cancer.

Key Dates

First listed
Oct 21, 2013
Start date
Nov 11, 2013
Status verified
Sep 2017
Primary completion
Jul 23, 2015
Completion
Jul 23, 2015

Study Design

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

Arms

  • Experimental: ABP 215
    Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
  • Active Comparator: Bevacizumab
    Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.

Primary Outcome Measure

Percentage of Participants With an Objective Response [ Time Frame: Disease assessments were performed at weeks 1, 7, 13, 19, and approximately every 9 weeks thereafter. The mean actual follow-up time from randomization was 4.7 and 5.0 months for ABP 215 and bevacizumab, respectively. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteBismarckNorth Dakota58501-

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Research Site· Bismarck, ND

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