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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.
Sponsored by: Genentech
Information provided by: Genentech
ClinicalTrials.gov Identifier: NCT00257608
  Purpose

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.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: bevacizumab
Drug: placebo
Drug: erlotinib HCl
Phase III

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Erlotinib Erlotinib hydrochloride Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Official Title: 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

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Post-chemo phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1150
Study Start Date: January 2006
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: bevacizumab
Intravenous repeating dose
Drug: erlotinib HCl
Oral repeating dose
2: Placebo Comparator Drug: bevacizumab
Intravenous repeating dose
Drug: placebo
Oral repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00257608

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Sponsors and Collaborators
Genentech
Investigators
Study Director: Donald Strickland, M.D. Genentech
  More Information

Responsible Party: Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers: AVF3671g
Study First Received: November 21, 2005
Last Updated: September 29, 2008
ClinicalTrials.gov Identifier: NCT00257608  
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
NSCLC
Lung Cancer
ATLAS
Avastin
Tarceva

Study placed in the following topic categories:
Erlotinib
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Bevacizumab
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Angiogenesis Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009