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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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)
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
Secondary ID [1] 0 0
BO20800
Secondary ID [2] 0 0
AVF3671g
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
Approximately 3 years
Secondary outcome [1] 0 0
Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Chemotherapy Phase
Timepoint [1] 0 0
Approximately 3 years
Secondary outcome [2] 0 0
Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Post-Chemotherapy Phase
Timepoint [2] 0 0
Approximately 3 years
Secondary outcome [3] 0 0
Number of Participants With Any Adverse Events During Post-Chemotherapy Phase
Timepoint [3] 0 0
Approximately 3.5 years
Secondary outcome [4] 0 0
Incidence of Study Treatment Discontinuation for Reasons Other Than Disease Progression in Chemotherapy Phase
Timepoint [4] 0 0
Approximately 3 years
Secondary outcome [5] 0 0
Incidence of Study Treatment Discontinuation
Timepoint [5] 0 0
Approximately 3 years
Secondary outcome [6] 0 0
Overall Survival
Timepoint [6] 0 0
Approximately 3.5 years

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2014
Sample size
Target
Accrual to date
Final
1145
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Holy Spirit Hospital Northside - Chermside, QLD
Recruitment hospital [2] 0 0
Sunshine Coast Cancer Centre - Nambour, QLD
Recruitment hospital [3] 0 0
Sir Charles Gairdner Hospital - Nedlands, WA
Recruitment hospital [4] 0 0
Burnside War Memorial Hospital - Toorak Gardens, SA
Recruitment postcode(s) [1] 0 0
4032 - Chermside, QLD
Recruitment postcode(s) [2] 0 0
4560 - Nambour, QLD
Recruitment postcode(s) [3] 0 0
6009 - Nedlands, WA
Recruitment postcode(s) [4] 0 0
5065 - Toorak Gardens, SA
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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California
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Colorado
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District of Columbia
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Florida
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Georgia
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Illinois
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Indiana
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Iowa
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Montana
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Nebraska
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Nevada
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Vermont
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Virginia
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Washington
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West Virginia
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Argentina
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Mendoza
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Argentina
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Resistencia
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Argentina
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Rosario
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Argentina
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Sante Fe
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Belgium
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Brussels
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Belgium
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Liege
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Brazil
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Rio de Janeiro
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Brazil
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Sao Paulo
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Bulgaria
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Plovdiv
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Bulgaria
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Rousse
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Bulgaria
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Shoumen
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Bulgaria
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Sofia
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Bulgaria
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Stara Zagora
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Bulgaria
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Varna
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Bulgaria
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Veliko Tarnovo
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Hong Kong
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Hong Kong
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Israel
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Jerusalem
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Israel
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Tel-Aviv
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Israel
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Tel-Hashomer
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Italy
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Genova
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Italy
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Napoli
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Italy
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Parma
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Italy
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Perugia
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Italy
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Udine
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Mexico
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Acapulco
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Mexico
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Distrito Federal
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Mexico
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Merida
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Mexico
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Torreon, Coahuila
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Philippines
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Luzon
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Philippines
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Visayas
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Philippines
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Manila
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Philippines
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Quezon City
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Romania
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Iasi
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Romania
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Sibiu
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Romania
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Suceava
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Singapore
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Singapore
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Spain
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Barcelona
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Spain
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Barakaldo
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Spain
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La Laguna
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Spain
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Valencia
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Taiwan
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Thailand
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Bangkok
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Thailand
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Chiangmai
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United Kingdom
State/province [83] 0 0
Bristol

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00257608
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Donald Strickland, M.D.
Address 0 0
Genentech, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00257608