Back to Search Results
Study Complete
Sponsor ID
20120265

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

Sponsor ID
20120265
Clinicaltrials.gov ID
NCT01966003
EUCTIS ID
N/A
EudraCT ID
2013-000738-36
Contact Us

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.

Additional Study Details

Phase
Phase 3
Product
ABP 215
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
642
Additional Study Details

Protocol Summary

Primary Outcome Measures

Objective response rate

Timeframe: up to 19 weeks

Secondary Outcome Measures

Objective response rate

Timeframe: up to 19 weeks

Duration of response

Timeframe: up to 19 weeks

Progression-free survival

Timeframe: 24 months

Treatment-emergent adverse events

Timeframe: up to 19 weeks

Treatment-emergent serious adverse events

Timeframe: up to 19 weeks

Incidence of anti-drug antibodies

Timeframe: up to 45 weeks

Overall survival

Timeframe: 24 months

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Bismarck, ND, United States, 58501
Status
Completed
Location
Research Site
Fremantle, WA, Australia, 6160
Status
Completed
Location
Research Site
Ruse, Bulgaria, 7003
Status
Completed
Location
Research Site
Veliko Tarnovo, VELIKO TURNOVO, Bulgaria, 5000
Status
Completed
Study Info
Age
18 - 80 Years
Condition
  • Lung Cancer - Non-Small Cell
    • Sex
    All
    Trial Dates
    Nov 2013 - Jul 2015
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC) - 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