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, Inc.
ClinicalTrials.gov Identifier:
NCT00257608
First received: November 21, 2005
Last updated: August 16, 2013
Last verified: August 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

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 ]

Enrollment: 1145
Study Start Date: January 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab
Intravenous repeating dose
Drug: erlotinib HCl
Oral repeating dose
Placebo Comparator: 2 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
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: NCT00257608

  Show 247 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Donald Strickland, M.D. Genentech, Inc.
  More Information

No publications provided by Genentech, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00257608     History of Changes
Other Study ID Numbers: AVF3671g
Study First Received: November 21, 2005
Last Updated: August 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
NSCLC
Lung Cancer
ATLAS
Avastin
Tarceva

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Bevacizumab
Erlotinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014