A Study Comparing Bevacizumab Therapy With or Without Erlotinib for First-Line Treatment of Non-Small Cell Lung Cancer (ATLAS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00257608
First received: November 21, 2005
Last updated: August 16, 2013
Last verified: August 2013

November 21, 2005
August 16, 2013
January 2006
December 2013   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: Post-chemo phase ] [ Designated as safety issue: No ]
To compare progression free survival (PFS) in subjects randomized to bevacizumab+erlotinib versus bevacizumab+erlotinib placebo in subjects with non squamous non-small cell lung cancer (NSCLC).
Complete list of historical versions of study NCT00257608 on ClinicalTrials.gov Archive Site
  • All adverse events [ Time Frame: Post-chemo phase ] [ Designated as safety issue: No ]
  • Serious and selected adverse events [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Study treatment discontinuation for reasons other than disease progression [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Until death or loss to follow-up ] [ Designated as safety issue: No ]
To evaluate the safety of bevacizumab during the chemotherapy phase by chemotherapy regimen and overall; to evaluate the safety of bevacizumab+erlotinib versus bevacizumab+erlotinib-placebo.
Not Provided
Not Provided
 
A Study Comparing Bevacizumab Therapy With or Without Erlotinib for First-Line Treatment of Non-Small Cell Lung Cancer (ATLAS)
A Randomized, Double-Blind, Placebo-Controlled, Phase IIIb Trial Comparing Bevacizumab Therapy With or Without Erlotinib After Completion of Chemotherapy With Bevacizumab for the First-Line Treatment of Locally Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer

This is a Phase IIIb, multicenter, randomized, placebo-controlled trial to evaluate the safety and efficacy of chemotherapy+bevacizumab followed by bevacizumab+erlotinib versus bevacizumab+erlotinib placebo in subjects with locally advanced or metastatic NSCLC.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: bevacizumab
    Intravenous repeating dose
  • Drug: placebo
    Oral repeating dose
  • Drug: erlotinib HCl
    Oral repeating dose
  • Experimental: 1
    Interventions:
    • Drug: bevacizumab
    • Drug: erlotinib HCl
  • Placebo Comparator: 2
    Interventions:
    • Drug: bevacizumab
    • Drug: placebo
Johnson BE, Kabbinavar F, Fehrenbacher L, Hainsworth J, Kasubhai S, Kressel B, Lin CY, Marsland T, Patel T, Polikoff J, Rubin M, White L, Yang JC, Bowden C, Miller V. ATLAS: randomized, double-blind, placebo-controlled, phase IIIB trial comparing bevacizumab therapy with or without erlotinib, after completion of chemotherapy, with bevacizumab for first-line treatment of advanced non-small-cell lung cancer. J Clin Oncol. 2013 Nov 1;31(31):3926-34. doi: 10.1200/JCO.2012.47.3983. Epub 2013 Oct 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1145
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Signed Informed Consent Form
  • Histologically or cytologically confirmed NSCLC
  • Advanced NSCLC or recurrent disease
  • INR no greater than 1.3 and aPTT no greater than upper limits of normal (ULN) within 28 days prior to enrollment for subjects not on low molecular weight heparin or fondaparinux. Subjects on low molecular weight heparin or fondaparinux are not required to meet INR or aPTT limits. Chronic full-dose anticoagulation with warfarin is not permitted.
  • 18 years of age or older
  • For women of childbearing potential and sexually active men, use of an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to enrollment and for the duration of the study

Exclusion Criteria:

  • Prior systemic chemotherapy in the metastatic setting
  • Treatment with an investigational or marketed agent that acts by either EGFR inhibition or anti-angiogenesis mechanisms
  • Pregnancy or lactation
  • Any other medical condition, including mental illness or substance abuse, deemed by the clinician to be likely to interfere with a subject's ability to provide informed consent, cooperate, and participate in the study, or to interfere with the interpretation of the results
  • Active infection or a fever within 3 days of enrollment
  • Active malignancy other than lung cancer
  • Radiation therapy to sites other than whole brain within 14 days prior to enrollment
  • History of gross hemoptysis within 3 months prior to enrollment
  • Known hypersensitivity to any of the components of cytotoxic chemotherapy combinations, bevacizumab, or tyrosine kinase inhibitors
  • Inadequately controlled hypertension
  • Unstable angina or New York Heart Association Grade II or greater CHF
  • Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to enrollment
  • History of myocardial infarction within 6 months prior to enrollment
  • History of stroke within 6 months prior to enrollment
  • Symptomatic peripheral vascular disease within 6 months prior to enrollment
  • Evidence of bleeding diathesis or coagulopathy
  • Serious, non-healing wound, ulcer, or bone fracture
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment; anticipation of need for major surgical procedure during the course of the study
  • Current, recent, or planned participation in an experimental drug study other than this Genentech-sponsored bevacizumab/erlotinib study
  • Progressive neurologic symptoms in subjects with a history of brain metastases
  • History of significant vascular disease (e.g., aortic aneurysm)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   Hong Kong,   Israel,   Italy,   Mexico,   Philippines,   Romania,   Singapore,   Spain,   Taiwan,   Thailand,   United Kingdom
 
NCT00257608
AVF3671g
Not Provided
Genentech
Genentech
Not Provided
Study Director: Donald Strickland, M.D. Genentech
Genentech
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP