Observational Study to Evalute the Efficacy and Safety of Avastin (Bevacizumab) in Addition to Platinum-Based Chemotherapy for First-Line Treatment of Participants With Non-Small Cell Lung Cancer
AVALANCHE
A Multi-Center Observational Survey of the Efficacy and Safety of Avastin in Addition to Platimun-Based Chemotherapy for First-Line Treatment of Patients With Locally Advanced, Metastatic or Recurrent Non-Small Cell Lung Cancer Other Than Predominantly Squamous Cell Histology
1 other identifier
observational
150
1 country
33
Brief Summary
The purpose of this study is to examine the efficacy of Bevacizumab in addition to platinum-based chemotherapy for first-line treatment of participants with advanced stage (IIIB/IV) non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2008
Longer than P75 for all trials
33 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
Study Start
First participant enrolled
June 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 26, 2017
CompletedFirst Posted
Study publicly available on registry
May 31, 2017
CompletedMay 31, 2017
May 1, 2017
4.1 years
May 26, 2017
May 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Time to Disease Progression
Time to progression is the time elapsed from the date of enrollment to the first documented progression or to death of any cause. For participants who don't show progression or die until the end of treatment, the date of last contact is taken as the censoring time.
up to 45 months
Secondary Outcomes (3)
Best Tumor Response
Up to 45 months
Overall Survival
Up to 45 months
Number of Participants with Serious Adverse Events (SAEs) and Adverse Events (AEs)
Up to 45 months
Study Arms (1)
Bevacizumab
Participants with advanced (stage IIIB/IV) NSCLC other than predominantly squamous cell histology receiving Bevacizumab in accordance with the summary product characteristics (SPC) is observed.
Interventions
Eligibility Criteria
Participants with locally advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology needing first-line treatment is observed.
You may qualify if:
- In accordance with the SPC. Most important criteria:
- Histology or cytology proven inoperable, locally advanced,metastatic or recurrent (stage IIIB/IV) NSCLC other than predominantly squamous cell histology
- First-line treatment is indicated
- No previous treatment with Bevacizumab
You may not qualify if:
- In accordance with the SPC. Most important criteria:
- Hypersensitivity to the active ingredient or to any of the excipients
- Hypersensitivity to products derived from Chinese hamster ovary (CHO) cells or to other recombinant human or humanized antibodies
- Pregnancy
- Bevacizumab is contraindicated in the presence of untreated central nervous system metastases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Ogyi, Orszagos Gyogyszereszeti Intezet
Budapest, 1051, Hungary
Szent Imre Hospital; Dept. of Oncology
Budapest, 1115, Hungary
Orszagos Koranyi TBC es Pulmonologiai Intezet
Budapest, 1121, Hungary
Orszagos Onkologial Intezet; Onkologiai Osztaly X
Budapest, 1122, Hungary
Semmelweis Egyetem X; Pulmonologiai Klinika
Budapest, 1125, Hungary
Uzsoki Utcai Korhaz; Ii. Belgyogyaszat
Budapest, 1145, Hungary
Debrecen Uni Medical School; Dept of Pulmonary Medicine
Debrecen, 4032, Hungary
Hajdú-Bihar Megyei Önkormányzat Kenézy Gyula Hospital; Infektology Department
Debrecen, H-4031, Hungary
Csongrad Megyei Onkormanyzat Mellkasi Betegsegek Szakkorhaza
Deszk, 6772, Hungary
Koch Robert Korhaz
Edelény, 3780, Hungary
Megyei Tudogyogyintezet - Pulmonologia
Farkasgyepű, 8582, Hungary
Hospital of Aladar Petz; Dept of Oncoradiology
Győr, 9023, Hungary
Petz Aladár County Teaching Hospital; 2nd Department of Psychiatry
Győr, 9024, Hungary
Bekes Megyei Tudokorhaz; I. Tudobelosztaly
Gyula, 5703, Hungary
Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
Gyula, 5703, Hungary
Kaposi Mor County Hospital; Dept. of Oncology
Kaposvár, 7400, Hungary
Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont
Kecskemét, 6000, Hungary
Matrai Állami Gyógyintézet ; Bronchológia
Mátraháza, 3233, Hungary
Szent Ferenc Kórház; Belgyógyászat
Miskolc, 3529, Hungary
Karolina Korhaz
Mosonmagyaróvár, 9200, Hungary
Josa Andras Korhaz; Dept of Oncoradiology
Nyíregyháza, 4400, Hungary
Szabolcs-Szatmar-Bereg County Josa Andras Hospital; 1St Depatment of Pulmonary Medicine
Nyíregyháza, 4400, Hungary
Pécsi Tudományegyetem Áok; Onkoterapias Intezet
Pécs, 7623, Hungary
Baranya County Hospital; Pulmonology Dept
Pécs, 7635, Hungary
Sopron Megyei Jogu Varos Erzsebet Korhaza Mellkasgyogyaszat
Sopron, 9400, Hungary
Tolna Megyei Balassa Janos Korhaz; Iv. Belgyogyaszati Osztaly
Szekszárd, 7100, Hungary
Fejér Megyei Szent György Kórház; Pulmonary Medicine
Székesfehérvár, 8001, Hungary
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály
Szolnok, 5004, Hungary
Vas Megyei Markusovszky Korhaz ; Oncoradiology
Szombathely, 9700, Hungary
Vas Megyei Markusovszky Korhaz ; Pulmonology
Szombathely, 9700, Hungary
Komarom-Esztergom Megyei Onkormanyzat Szent Borbala Korhaz; Haematologiai Osztaly
Tatabánya, 2800, Hungary
Inst. of Pulmonary Medicine, Torokbalint; 2Nd Dept of Pulmonary Medicine
Törökbálint, 2045, Hungary
Zala Megyei Korhaz; Dept of Pulmonary Medicine
Zalaegerszeg, 8900, Hungary
Related Publications (1)
Tolnay E, Ghimessy AK, Juhasz E, Sztancsik Z, Losonczy G, Dombi P, Vennes Z, Helf L, Csada E, Sarosi V. The efficacy and safety of bevacizumab in addition to platinum-based chemotherapy for the first-line treatment of patients with advanced nonsquamous non-small-cell lung cancer: Final results of AVALANCHE, an observational cohort study. Oncol Lett. 2019 Feb;17(2):1750-1760. doi: 10.3892/ol.2018.9766. Epub 2018 Nov 27.
PMID: 30675234DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2017
First Posted
May 31, 2017
Study Start
June 17, 2008
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
May 31, 2017
Record last verified: 2017-05