A Study of Avastin (Bevacizumab) in Combination With Carboplatin-Based Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer.
A Randomized, Open-label Study to Explore the Correlation of Biomarkers With Response Rate in Chemo-naive Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer Who Receive Treatment With Avastin in Addition to Carboplatin-based Chemotherapy
2 other identifiers
interventional
303
16 countries
59
Brief Summary
This study will explore the correlation of biomarkers with response rate, and the overall efficacy and safety, of Avastin in combination with carboplatin-based chemotherapy in patients with advanced or recurrent non-squamous non-small cell lung cancer. Patients will be randomized to one of 2 groups, to receive either Avastin 7.5mg/kg iv on day 1 of each 3 week cycle, or Avastin 15mg/kg iv on day 1 of each 3 week cycle; all patients will also receive treatment with carboplatin and either gemcitabine or paclitaxel for a maximum of 6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
Started Sep 2008
Typical duration for phase_2 nonsmall-cell-lung-cancer
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2008
CompletedFirst Posted
Study publicly available on registry
June 18, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
September 25, 2014
CompletedSeptember 25, 2014
September 1, 2014
4 years
June 17, 2008
September 16, 2014
September 23, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) by Dichotomized Baseline Plasma Marker Level
Overall response was analyzed and correlated within dichotomized (low- and high-level) baseline plasma biomarker (basic fibroblast growth factor \[bFGF\], E-selection, intracellular adhesion molecule \[ICAM\], placental growth factor \[PlGF\], vascular endothelial growth factor A \[VEGF A\], vascular endothelial growth factor receptor \[VEGFR\]-1, and VEGFR-2) subgroups: low-level equals (=) less than or equal to (≤) median baseline level, high-level=greater than (\>) median baseline level. Per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.0 CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of the longest diameter (LD) of all target lesions. No unequivocal progression of non-target disease; no new lesions. Complete and partial responses must have been confirmed no less than 4 weeks after criteria for response were first met
Baseline, Day 21 of Cycles 2, 4, and 6 (Bv + chemo), Day 21 of Cycles 7, 8, 9, and 10 (Bv), Day 21 of every other cycle (Bv), and at disease progression.
Secondary Outcomes (8)
Progression-Free Survival - Percentage of Participants With an Event
Baseline, Day 1, weekly to disease progression
Progression-Free Survival - Time to Event
Baseline, Day 1, weekly to disease progression
Percentage of Participants With Objective Response
Baseline, Day 21 of Cycles 2, 4, and 6, Day 21 of Cycles 7, 8, 9, and 10, Day 21 of every other cycle, and at disease progression
Percentage of Participants With Measurable Disease at Baseline Who Achieved CR, PR, or Stable Disease (SD) for at Least 6 Weeks
Baseline, Day 21 of Cycles 2, 4, and 6, Day 21 of Cycles 7, 8, 9, and 10, Day 21 of every other cycle, and at disease progression
Duration of Response - Percentage of Participants With an Event
Baseline, Day 21 of Cycles 2, 4, and 6, Day 21 of Cycles 7, 8, 9, and 10, Day 21 of every other cycle, and at disease progression
- +3 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- adult patients, \>=18 years of age;
- locally advanced metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC);
- \>=1 measurable tumor lesion;
- ECOG performance status 0-1.
You may not qualify if:
- prior chemotherapy or treatment with another systemic anti-cancer agent;
- evidence of CNS metastases;
- history of grade 2 or higher hemoptysis;
- evidence of tumor invading or abutting major blood vessels;
- malignancies other than NSCLC within 5 years prior to randomization, other than adequately treated cancer in situ of cervix, basal or squamous cell skin cancer, localized prostate cancer or DCIS;
- clinically significant cardiovascular disease;
- current or recent use of aspirin (\>325mg/day) or full dose anticoagulants or thrombolytic agents for therapeutic purposes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (59)
Unknown Facility
St Leonards, New South Wales, 2065, Australia
Unknown Facility
Adelaide, South Australia, 5041, Australia
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Adelaide, South Australia, 5065, Australia
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Box Hill, Victoria, 3128, Australia
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Fitzroy, Victoria, 3065, Australia
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Antwerp, 2020, Belgium
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Liège, 4000, Belgium
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Vancouver, British Columbia, V5Z 4E6, Canada
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Toronto, Ontario, M5G2M9, Canada
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Ostrava, 708 52, Czechia
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Prague, 180 01, Czechia
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Odense, 5000, Denmark
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Paris, 75970, France
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Rouen, 76031, France
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Bad Berka, 99437, Germany
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GroĂŸhansdorf, 22927, Germany
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Hamburg, 21075, Germany
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Oldenburg, 26121, Germany
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Hong Kong, 852, Hong Kong
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Hong Kong, Hong Kong
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Budapest, 1529, Hungary
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Edelény, 3780, Hungary
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Sopron, 9400, Hungary
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Szombathely, 9700, Hungary
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TörökbĂ¡lint, 2045, Hungary
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Milan, 20141, Italy
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Milan, 20162, Italy
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Orbassano, 10043, Italy
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Roma, 00168, Italy
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Enschede, 7500 KA, Netherlands
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Hoorn, 1624 NP, Netherlands
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Nieuwegein, 3435 CM, Netherlands
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Rotterdam, 3075 EA, Netherlands
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The Hague, 2504 LN, Netherlands
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Poznan, 60-569, Poland
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Warsaw, 02-781, Poland
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Zabrze, 41-843, Poland
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Arkhangelsk, 163045, Russia
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Chelyabinsk, 454 087, Russia
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Kazan', 420029, Russia
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Kazan', 420111, Russia
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Krasnodar, 350040, Russia
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Krasnodar, 350086, Russia
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Moscow, 105229, Russia
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Moscow, 115478, Russia
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Saint Petersburg, 197089, Russia
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Saint Petersburg, 197758, Russia
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Seville, Sevilla, 41013, Spain
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Valencia, Valencia, 46009, Spain
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Valencia, Valencia, 46010, Spain
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Barakaldo, Vizcaya, 48903, Spain
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Changhua, 500, Taiwan
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Taichung, 402, Taiwan
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Taichung, 404, Taiwan
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Taichung, 407, Taiwan
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Taipei, 100, Taiwan
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Aberdeen, AB25 2ZN, United Kingdom
Unknown Facility
Chelmsford, CM1 7ET, United Kingdom
Unknown Facility
London, SE1 9RT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2008
First Posted
June 18, 2008
Study Start
September 1, 2008
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
September 25, 2014
Results First Posted
September 25, 2014
Record last verified: 2014-09