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

Carcinoma, Non-Small-Cell Lung Clinical Trial

— AVALANCHE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03170284
• Other study ID #: ML21783
• Status: Completed
• Phase: N/A
• First received: May 26, 2017
• Last updated: May 26, 2017
• Start date: June 17, 2008
• Est. completion date: August 1, 2012

Study information

• Verified date: May 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 1, 2012
• Est. primary completion date: August 1, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Bevacizumab
Bevacizumab is prescribed by physicians as per SPC.

Locations

Country	Name	City	State
Hungary	Ogyi, Orszagos Gyogyszereszeti Intezet	Budapest
Hungary	Orszagos Koranyi TBC es Pulmonologiai Intezet	Budapest
Hungary	Orszagos Onkologial Intezet; Onkologiai Osztaly X	Budapest
Hungary	Semmelweis Egyetem X; Pulmonologiai Klinika	Budapest
Hungary	Szent Imre Hospital; Dept. of Oncology	Budapest
Hungary	Uzsoki Utcai Korhaz; Ii. Belgyogyaszat	Budapest
Hungary	Debrecen Uni Medical School; Dept of Pulmonary Medicine	Debrecen
Hungary	Hajdú-Bihar Megyei Önkormányzat Kenézy Gyula Hospital; Infektology Department	Debrecen
Hungary	Csongrad Megyei Onkormanyzat Mellkasi Betegsegek Szakkorhaza	Deszk
Hungary	Koch Robert Korhaz	Edeleny
Hungary	Megyei Tudogyogyintezet - Pulmonologia	Farkasgyepu
Hungary	Hospital of Aladar Petz; Dept of Oncoradiology	Gyor
Hungary	Petz Aladár County Teaching Hospital; 2nd Department of Psychiatry	Gyor
Hungary	Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek	Gyula
Hungary	Bekes Megyei Tudokorhaz; I. Tudobelosztaly	Gyula
Hungary	Kaposi Mor County Hospital; Dept. of Oncology	Kaposvar
Hungary	Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont	Kecskemet
Hungary	Matrai Állami Gyógyintézet ; Bronchológia	Mátraháza
Hungary	Szent Ferenc Kórház; Belgyógyászat	Miskolc
Hungary	Karolina Korhaz	Mosonmagyaróvár
Hungary	Szabolcs-Szatmar-Bereg County Josa Andras Hospital; 1St Depatment of Pulmonary Medicine	Nyiregyhaza
Hungary	Josa Andras Korhaz; Dept of Oncoradiology	Nyíregyháza
Hungary	Baranya County Hospital; Pulmonology Dept	Pecs
Hungary	Pécsi Tudományegyetem Áok; Onkoterapias Intezet	Pecs
Hungary	Sopron Megyei Jogu Varos Erzsebet Korhaza Mellkasgyogyaszat	Sopron
Hungary	Fejér Megyei Szent György Kórház; Pulmonary Medicine	Szekesfehervar
Hungary	Tolna Megyei Balassa Janos Korhaz; Iv. Belgyogyaszati Osztaly	Szekszard
Hungary	Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály	Szolnok
Hungary	Vas Megyei Markusovszky Korhaz ; Oncoradiology	Szombathely
Hungary	Vas Megyei Markusovszky Korhaz ; Pulmonology	Szombathely
Hungary	Komarom-Esztergom Megyei Onkormanyzat Szent Borbala Korhaz; Haematologiai Osztaly	Tatabánya
Hungary	Inst. of Pulmonary Medicine, Torokbalint; 2Nd Dept of Pulmonary Medicine	Torokbalint
Hungary	Zala Megyei Korhaz; Dept of Pulmonary Medicine	Zalaegerszeg

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Best Tumor Response	Best tumor response is evaluated as percentage of participants with complete remission (CR), partial response (PR), stable disease (SD) and progressive disease.	Up to 45 months
Secondary	Overall Survival	Overall survival is the time elapsed between enrollment and death of any cause. For participants who don't die until the end of treatment, the overall survival data will be analyzed retrospectively based on their date of death after the end of study.	Up to 45 months
Secondary	Number of Participants with Serious Adverse Events (SAEs) and Adverse Events (AEs)	An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.	Up to 45 months