- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00531960
A Study of Tarceva (Erlotinib) in Combination With Avastin (Bevacizumab) in Patients With Advanced Non-Small Cell Lung Cancer.
November 4, 2014 updated by: Hoffmann-La Roche
A Randomized, Open-label Study Comparing the Anti-tumor Effect of Treatment With Tarceva Plus Avastin Versus Chemotherapy Plus Avastin in Patients With Advanced Non-small Cell Lung Cancer
This 2 arm study will compare the efficacy and safety of Tarceva plus Avastin, and chemotherapy plus Avastin, in the first-line treatment of patients with advanced non-small cell lung cancer.
Patients will be randomized to receive either Tarceva 150mg p.o. daily plus Avastin 15mg/kg i.v.
every 3 weeks, or standard platinum-based chemotherapy (4-6 cycles) plus Avastin.
The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
124
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Victoria
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East Bentleigh, Victoria, Australia, VIC 3165
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Geelong, Victoria, Australia, 3220
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Leuven, Belgium, 3000
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Bayonne, France, 64100
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Dijon, France, 21079
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Le Mans, France, 72037
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Marseille, France, 13273
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Paris, France, 75674
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Strasbourg, France, 67091
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Vandoeuvre-les-nancy, France, 54511
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Friuli-Venezia Giulia
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Aviano, Friuli-Venezia Giulia, Italy, 33081
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Lombardia
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Milano, Lombardia, Italy, 20133
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Marche
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Ancona, Marche, Italy, 60121
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Toscana
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Lido Di Camaiore, Toscana, Italy, 55043
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Bundang City, Korea, Republic of, 463-802
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Daegu, Korea, Republic of, 700-712
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Gyeonggi-do, Korea, Republic of, 411-769
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Incheon, Korea, Republic of, 405-760
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Seoul, Korea, Republic of, 138-736
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Seoul, Korea, Republic of, 110-744
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Seoul, Korea, Republic of, 120-752
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Seoul, Korea, Republic of, 135-710
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Seoul, Korea, Republic of, 137-807
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Suwon, Korea, Republic of
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Kaunas, Lithuania, 50009
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Vilnius, Lithuania, 08660
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's Hertogenbosch, Netherlands, 5211 RW
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Amsterdam, Netherlands, 1007 MB
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Eindhoven, Netherlands, 5623 EJ
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Groningen, Netherlands, 9713 GZ
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Heerlen, Netherlands, 6419 PC
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Maastricht, Netherlands, 6229 HX
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Rotterdam, Netherlands, 3045 PM
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Lodz, Poland, 91-520
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Lublin, Poland, 20-950
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Otwock, Poland, 05-400
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Bucuresti, Romania, 022328
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Cluj Napoca, Romania, 400015
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Timisoara, Romania, 1900
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Singapore, Singapore, 119074
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Alicante, Spain, 3010
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Barcelona, Spain, 08035
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La Coruña, Spain, 15006
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Madrid, Spain, 28046
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Madrid, Spain, 28041
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Madrid, Spain, 28222
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Malaga, Spain, 29010
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Sevilla, Spain, 41014
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Changhua, Taiwan, 500
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Kaohsiung, Taiwan, 00833
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Tainan, Taiwan, 710
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Taipei, Taiwan
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Taipei, Taiwan, 114
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Taipei, Taiwan, 112
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Dudley, United Kingdom, DY1 2HQ
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Guildford, United Kingdom, GU2 7XX
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Manchester, United Kingdom, M2O 4BX
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adult patients, >=18 years of age;
- advanced (stage IIIb and IV) non-small cell lung cancer;
- measurable disease;
- ECOG PS 0-1.
Exclusion Criteria:
- prior chemotherapy or treatment with another systemic anti-cancer agent;
- radiotherapy within 4 weeks prior to first dose of study treatment;
- CNS metastases;
- other malignancies in past 5 years, except for adequately treated cancer in situ of the cervix, basal or squamous cell skin cancer.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Bevacizumab, Chemotherapy
Participants received bevacizumab, 15 milligrams (mg) per (/) kilogram (kg), intravenously (IV), on Day 1 of Cycles 1 through 7 until disease progression, unacceptable toxicity, death, or withdrawal.
Participants also received 4 to 6 cycles of a standard platinum-containing regimen of chemotherapy: either gemcitabine, 1250 mg/ square meter (m^2), IV, on Days 1 and 8 of Cycles 1 through 4 or 6, and cisplatin 80 mg/m^2, IV, on Day 1 of Cycles 1 through 4 or 6; or paclitaxel, 200 mg/m^2, IV, and carboplatin area under the curve (AUC) 6 mg/ milliliter (ml) multiplied by (*) minute (min) on Day 1 of Cycles 1 through 4 or 6.
The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
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15 mg/kg, IV, Day 1 of Cycles 1 through 7
Other Names:
At the discretion of the investigator
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Experimental: Bevacizumab, Erlotinib
Participants received bevacizumab, 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 until disease progression, unacceptable toxicity, death, or withdrawal.
Participants also received erlotinib, 150 mg, orally (PO), daily until disease progression, unacceptable toxicity, death, or withdrawal.
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15 mg/kg, IV, Day 1 of Cycles 1 through 7
Other Names:
150 mg, PO, daily
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants With Disease Progression or Death
Time Frame: Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
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Progression-free survival (PFS) was defined as the time from randomization to disease progression or death, from any cause.
Progressive disease (PD) was defined according to Response Criteria in Solid Tumors (RECIST) version (V) 1.0.
For target lesions (TLs), progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment.
For non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs.
Participants were censored at the date of last post-baseline (BL) tumor assessment where non-progression was documented.
If no post-BL tumor assessment was available, the participant was censored at date of randomization.
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Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
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PFS
Time Frame: Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
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The median time, in weeks, from randomization to PFS event.
Participants were censored at the date of last post-BL tumor assessment where non-progression was documented.
If no post-BL tumor assessment was available, the participant was censored at date of randomization.
PFS was estimated using Kaplan-Meier methodology.
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Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants Who Died
Time Frame: Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
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Overall survival (OS) was defined as the time from randomization to the date of death, due to any cause.
Participants were censored at final analysis at the date the participant was last known to be alive.
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Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
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OS
Time Frame: Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
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The median time, in months, from randomization to OS event.
Participants were censored at final analysis at the date the participant was last known to be alive.
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Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
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Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0
Time Frame: Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
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BOR was defined as the best response recorded from randomization until disease progression/recurrence or death, taking as reference for PD the smallest measurement (nadir) recorded since treatment started.
Assignment of PR of CR required confirmation of tumor measurement changes by repeat assessments performed no less than 4 weeks after criteria for response was first met.
For TLs, CR was defined as the disappearance of all TLs; and PR was defined as at least a 30% decrease in the SLD of the TLs, taking BL SLD as reference.
For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels.
The 95% CI for one sample binomial was calculated using the Pearson-Clopper method.
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Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
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Percentage of Participants With Disease Control According to RECIST V 1.0
Time Frame: Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis, 12 months after the last participant's 1st visit
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Disease control was defined as a BOR of CR, PR, or SD according to RECIST V 1.0 for at least 4 weeks at any time during randomized treatment or disease stabilization, after study entry.
Participants without a post-BL assessment of response were considered as having no disease control.
The 95% CI for the one sample binomial was calculated using the Pearson-Clopper method.
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Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis, 12 months after the last participant's 1st visit
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
September 18, 2007
First Submitted That Met QC Criteria
September 18, 2007
First Posted (Estimate)
September 19, 2007
Study Record Updates
Last Update Posted (Estimate)
November 11, 2014
Last Update Submitted That Met QC Criteria
November 4, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Erlotinib Hydrochloride
- Bevacizumab
Other Study ID Numbers
- BO20571
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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