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

This study has been completed.
Sponsor:
Collaborator:
Actavis Inc.
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01966003
First received: October 4, 2013
Last updated: April 7, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Non-small Cell Lung Cancer Metastatic Drug: carboplatin Drug: paclitaxel Drug: ABP 215 Drug: bevacizumab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Phase 3 Study Evaluating the Efficacy and Safety of ABP 215 Compared With Bevacizumab in Subjects With Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Objective response rate [ Time Frame: up to 19 weeks ]
    The actual endpoint is best response seen during the study.


Secondary Outcome Measures:
  • Objective response rate [ Time Frame: up to 19 weeks ]
    The actual endpoint is best response seen during the study

  • Duration of response [ Time Frame: up to 19 weeks ]
    Assessed at the end of the study

  • Progression-free survival [ Time Frame: 24 months ]
    Assessed at the end of the study

  • Treatment-emergent adverse events [ Time Frame: up to 19 weeks ]
    Assessment following therapy with either ABP 215 or bevacizumab

  • Treatment-emergent serious adverse events [ Time Frame: up to 19 weeks ]
    Assessment following therapy with either ABP 215 or bevacizumab

  • Incidence of anti-drug antibodies [ Time Frame: up to 45 weeks ]
    Assessment following therapy with either ABP 215 or bevacizumab

  • Overall survival [ Time Frame: 24 months ]
    Assessment following therapy with either ABP 215 or bevacizumab


Enrollment: 642
Actual Study Start Date: November 11, 2013
Study Completion Date: July 23, 2015
Primary Completion Date: July 23, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABP 215
Paclitaxel followed by carboplatin to be administered on the same day and after infusion of ABP 215 for up to 6 cycles.
Drug: carboplatin
AUC 6 IV, (in the vein)
Other Name: Paraplatin
Drug: paclitaxel
200 mg/m2, IV (in the vein)
Other Name: Taxol
Drug: ABP 215
15 mg/kg, IV (in the vein)
Active Comparator: bevacizumab
Paclitaxel followed by carboplatin to be administered on the same day and after infusion of bevacizumab for up to 6 cycles.
Drug: carboplatin
AUC 6 IV, (in the vein)
Other Name: Paraplatin
Drug: paclitaxel
200 mg/m2, IV (in the vein)
Other Name: Taxol
Drug: bevacizumab
15 mg/kg, IV (in the vein)
Other Name: Avastin

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed non-squamous non-small cell lung cancer
  • Subjects must be initiating first-line carboplatin/paclitaxel chemotherapy within 8 days after randomization and expected to receive at least 4 cycles of chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1

Exclusion Criteria:

  • Small cell lung cancer (SCLC) or mixed SCLC and NSCLC
  • Central nervous system (CNS) metastases
  • Malignancy other than NSCLC
  • Palliative radiotherapy for bone lesions inside the thorax
  • Prior radiotherapy of bone marrow
  • Known to be positive for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
  • Life expectancy < 6 months
  • Woman of child-bearing potential who is pregnant or is breast feeding or who is not consenting to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment
  • Man with a partner of childbearing potential who does not consent to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment
  • Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products
  • Other inclusion/exclusion criteria may apply
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01966003

Locations
United States, North Dakota
Research Site
Bismarck, North Dakota, United States, 58501
Australia, Western Australia
Research Site
Fremantle, Western Australia, Australia, 6160
Bulgaria
Research Site
Veliko Tarnovo, Veliko Turnovo, Bulgaria, 5000
Research Site
Ruse, Bulgaria, 7003
Sponsors and Collaborators
Amgen
Actavis Inc.
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01966003     History of Changes
Other Study ID Numbers: 20120265
2013-000738-36 ( EudraCT Number )
Study First Received: October 4, 2013
Last Updated: April 7, 2017

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Bevacizumab
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on June 28, 2017