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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00451906




Registration number
NCT00451906
Ethics application status
Date submitted
22/03/2007
Date registered
26/03/2007
Date last updated
24/05/2016

Titles & IDs
Public title
A Study of Avastin (Bevacizumab) in Combination With Platinum-Containing Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.
Scientific title
Open-label Study of Bevacizumab (AVASTIN®) in Combination With Platinum-containing Chemotherapy as First-line Treatment of Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer
Secondary ID [1] 0 0
MO19390
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Squamous 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 - Platinum-based chemotherapy
Treatment: Drugs - Bevacizumab [Avastin]

Experimental: Bevacizumab + Chemotherapy - Participants with advanced or recurrent NSCLC will be administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator's choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab will be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy.


Treatment: Drugs: Platinum-based chemotherapy
As prescribed

Treatment: Drugs: Bevacizumab [Avastin]
15 mg/kg IV on Day 1 of each 3 week cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events of Special Interest
Timepoint [1] 0 0
Up to 3 years
Primary outcome [2] 0 0
Number of Participants With Serious Adverse Events Related to Bevacizumab
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [1] 0 0
Duration of Overall Survival
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [2] 0 0
Time to Disease Progression
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [3] 0 0
Number of Participants With Central Nervous System Bleeding
Timepoint [3] 0 0
Up to 3 years

Eligibility
Key inclusion criteria
* adult patients, >=18 years of age;
* histologically or cytologically documented inoperable, locally advanced ( stage III), metastatic (stage IV) or recurrent NSCLC other than squamous cell (tumors of mixed histology should be categorized by the predominant cell type);
* ECOG PS status 0-2;
* life expectancy >= 12weeks;
* adequate renal, liver and hematological function.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* mixed, non-small and small cell tumors, or mixed adenosquamous carcinomas with a predominant squamous component;
* hemoptysis (>=1/2 teaspoon of bright red blood) in previous 3 months;
* evidence of tumor invading major blood vessels on imaging;
* evidence of CNS metastases, even if previously treated.
* major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment, or anticipation of need for major surgery during study treatment;
* prior chemotherapy for stage IIIb/IV disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
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
1/08/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2009
Sample size
Target
Accrual to date
Final
2252
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
- St. Leonards
Recruitment hospital [2] 0 0
- Waratah
Recruitment hospital [3] 0 0
- Auchenflower
Recruitment hospital [4] 0 0
- Chermside
Recruitment hospital [5] 0 0
- Tugun
Recruitment hospital [6] 0 0
- Box Hill
Recruitment hospital [7] 0 0
- Geelong
Recruitment hospital [8] 0 0
- Malvern
Recruitment hospital [9] 0 0
- Wodonga
Recruitment hospital [10] 0 0
- Perth
Recruitment hospital [11] 0 0
- Sydney, New South Wales
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
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2298 - Waratah
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4066 - Auchenflower
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4032 - Chermside
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4224 - Tugun
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3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3220 - Geelong
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3144 - Malvern
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3690 - Wodonga
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6008 - Perth
Recruitment postcode(s) [11] 0 0
2077 - Sydney, New South Wales
Recruitment outside Australia
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Argentina
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Feldkirch
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Nitra
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Poprad
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Golnik
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Slovenia
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Spain
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Barcelona
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Madrid
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Tenerife
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Girona
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Spain
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Huesca
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La Coruña
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Spain
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Lugo
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Spain
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Murcia
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Spain
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Country [228] 0 0
Spain
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Valencia
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Spain
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Zaragoza
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Sweden
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Gothenburg
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Baden
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State/province [239] 0 0
Genolier
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Locarno
Country [241] 0 0
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State/province [241] 0 0
Taichung
Country [242] 0 0
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State/province [242] 0 0
Tainan
Country [243] 0 0
Taiwan
State/province [243] 0 0
Taipei
Country [244] 0 0
Taiwan
State/province [244] 0 0
Taoyuan
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Turkey
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Gaziantep
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Belfast
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Porlamar

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This single arm study will assess the safety and efficacy of Avastin combined with platinum-containing chemotherapy regimens in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC). Avastin will be given as first-line treatment in combination with platinum-based chemotherapy or in combination with any standard of care NSCLC first-line chemotherapy used in line with the licensed national prescribing information. Eligible patients will receive Avastin (15mg/kg iv on day 1 of each 3 week cycle) concomitantly with chemotherapy. Avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 500+ individuals.
Trial website
https://clinicaltrials.gov/study/NCT00451906
Trial related presentations / publications
Bearz A, Passalacqua R, Alabiso O, Cinieri S, Gridelli C, Cravesana C, Crino L. First-line bevacizumab-based therapy in advanced non-squamous non-small-cell lung cancer : analysis of the Italian patients enrolled in the SAiL study. Clin Drug Investig. 2012 Nov;32(11):755-60. doi: 10.1007/s40261-012-0001-9.
Crino L, Dansin E, Garrido P, Griesinger F, Laskin J, Pavlakis N, Stroiakovski D, Thatcher N, Tsai CM, Wu YL, Zhou C. Safety and efficacy of first-line bevacizumab-based therapy in advanced non-squamous non-small-cell lung cancer (SAiL, MO19390): a phase 4 study. Lancet Oncol. 2010 Aug;11(8):733-40. doi: 10.1016/S1470-2045(10)70151-0. Epub 2010 Jul 23.
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
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/study/NCT00451906