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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00257608
Registration number
NCT00257608
Ethics application status
Date submitted
21/11/2005
Date registered
23/11/2005
Date last updated
18/04/2016
Titles & IDs
Public title
A Study Comparing Bevacizumab Therapy With or Without Erlotinib for First-Line Treatment of Non-Small Cell Lung Cancer (ATLAS)
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Scientific 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
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Secondary ID [1]
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BO20800
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Secondary ID [2]
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AVF3671g
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - bevacizumab
Treatment: Drugs - placebo
Treatment: Drugs - erlotinib HCl
Experimental: 1 -
Placebo comparator: 2 -
Treatment: Drugs: bevacizumab
Intravenous repeating dose
Treatment: Drugs: placebo
Oral repeating dose
Treatment: Drugs: erlotinib HCl
Oral repeating dose
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival (PFS)
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Assessment method [1]
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PFS was defined as the length of time from randomization until documented disease progression or death from any cause, whichever occurred earlier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Data presented until cut-off date 18 July 2008.
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Timepoint [1]
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Approximately 3 years
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Secondary outcome [1]
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Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Chemotherapy Phase
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Assessment method [1]
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Treatment-emergent adverse events were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.. Number of participants who had Grade \>=3TEAEs of pulmonary hemorrhage, gastrointestinal (GI) perforation, arterial thromboembolic (ATE) events, proteinuria, congestive heart failure (CHF), and hypertension were presented. Data presented up to data cutoff 18 July 2008.
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Timepoint [1]
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Approximately 3 years
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Secondary outcome [2]
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Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Post-Chemotherapy Phase
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Assessment method [2]
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Treatment-related adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state and are judged by the investigator to be possibly, probably or definitely related to study medication. Pulmonary hemorrhage, GI perforation, ATE events, proteinuria, CHF, and hypertension were prospectively identified TEAEs of grade \>=3. Data presented until cut-off date 28 January 2009.
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Timepoint [2]
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Approximately 3 years
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Secondary outcome [3]
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Number of Participants With Any Adverse Events During Post-Chemotherapy Phase
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Assessment method [3]
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An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event. Data presented up to data cutoff 19 June 2009.
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Timepoint [3]
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Approximately 3.5 years
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Secondary outcome [4]
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Incidence of Study Treatment Discontinuation for Reasons Other Than Disease Progression in Chemotherapy Phase
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Assessment method [4]
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Participants who experienced disease progression were discontinued from the study. Data presented up to data cutoff (18 July 2008).
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Timepoint [4]
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Approximately 3 years
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Secondary outcome [5]
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Incidence of Study Treatment Discontinuation
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Assessment method [5]
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Participants in post-chemotherapy phase were discontinued from the study for the reasons other than disease progression. Data presented Up to data cutoff 18 July 2008.
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Timepoint [5]
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Approximately 3 years
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Secondary outcome [6]
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Overall Survival
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Assessment method [6]
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Overall survival was defined as the length of time from randomization to death.
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Timepoint [6]
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Approximately 3.5 years
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2006
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Date of last participant enrolment
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Actual
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Date of last data collection
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Actual
1/11/2014
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Sample size
Target
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Accrual to date
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Final
1145
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Holy Spirit Hospital Northside - Chermside, QLD
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Sunshine Coast Cancer Centre - Nambour, QLD
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Sir Charles Gairdner Hospital - Nedlands, WA
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Burnside War Memorial Hospital - Toorak Gardens, SA
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4032 - Chermside, QLD
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4560 - Nambour, QLD
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6009 - Nedlands, WA
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5065 - Toorak Gardens, SA
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Bristol
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Genentech, Inc.
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Ethics approval
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00257608
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
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Donald Strickland, M.D.
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Genentech, Inc.
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00257608
Download to PDF
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