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

NCT ID: NCT03170284

Last Updated: 2017-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-17

Study Completion Date

2012-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Bevacizumab

Intervention Type DRUG

Bevacizumab is prescribed by physicians as per SPC.

Interventions

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Bevacizumab

Bevacizumab is prescribed by physicians as per SPC.

Intervention Type DRUG

Other Intervention Names

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Avastin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Ogyi, Orszagos Gyogyszereszeti Intezet

Budapest, , Hungary

Site Status

Szent Imre Hospital; Dept. of Oncology

Budapest, , Hungary

Site Status

Orszagos Koranyi TBC es Pulmonologiai Intezet

Budapest, , Hungary

Site Status

Orszagos Onkologial Intezet; Onkologiai Osztaly X

Budapest, , Hungary

Site Status

Semmelweis Egyetem X; Pulmonologiai Klinika

Budapest, , Hungary

Site Status

Uzsoki Utcai Korhaz; Ii. Belgyogyaszat

Budapest, , Hungary

Site Status

Debrecen Uni Medical School; Dept of Pulmonary Medicine

Debrecen, , Hungary

Site Status

Hajdú-Bihar Megyei Önkormányzat Kenézy Gyula Hospital; Infektology Department

Debrecen, , Hungary

Site Status

Csongrad Megyei Onkormanyzat Mellkasi Betegsegek Szakkorhaza

Deszk, , Hungary

Site Status

Koch Robert Korhaz

Edelény, , Hungary

Site Status

Megyei Tudogyogyintezet - Pulmonologia

Farkasgyepű, , Hungary

Site Status

Hospital of Aladar Petz; Dept of Oncoradiology

Győr, , Hungary

Site Status

Petz Aladár County Teaching Hospital; 2nd Department of Psychiatry

Győr, , Hungary

Site Status

Bekes Megyei Tudokorhaz; I. Tudobelosztaly

Gyula, , Hungary

Site Status

Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek

Gyula, , Hungary

Site Status

Kaposi Mor County Hospital; Dept. of Oncology

Kaposvár, , Hungary

Site Status

Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont

Kecskemét, , Hungary

Site Status

Matrai Állami Gyógyintézet ; Bronchológia

Mátraháza, , Hungary

Site Status

Szent Ferenc Kórház; Belgyógyászat

Miskolc, , Hungary

Site Status

Karolina Korhaz

Mosonmagyaróvár, , Hungary

Site Status

Josa Andras Korhaz; Dept of Oncoradiology

Nyíregyháza, , Hungary

Site Status

Szabolcs-Szatmar-Bereg County Josa Andras Hospital; 1St Depatment of Pulmonary Medicine

Nyíregyháza, , Hungary

Site Status

Pécsi Tudományegyetem Áok; Onkoterapias Intezet

Pécs, , Hungary

Site Status

Baranya County Hospital; Pulmonology Dept

Pécs, , Hungary

Site Status

Sopron Megyei Jogu Varos Erzsebet Korhaza Mellkasgyogyaszat

Sopron, , Hungary

Site Status

Tolna Megyei Balassa Janos Korhaz; Iv. Belgyogyaszati Osztaly

Szekszárd, , Hungary

Site Status

Fejér Megyei Szent György Kórház; Pulmonary Medicine

Székesfehérvár, , Hungary

Site Status

Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály

Szolnok, , Hungary

Site Status

Vas Megyei Markusovszky Korhaz ; Oncoradiology

Szombathely, , Hungary

Site Status

Vas Megyei Markusovszky Korhaz ; Pulmonology

Szombathely, , Hungary

Site Status

Komarom-Esztergom Megyei Onkormanyzat Szent Borbala Korhaz; Haematologiai Osztaly

Tatabánya, , Hungary

Site Status

Inst. of Pulmonary Medicine, Torokbalint; 2Nd Dept of Pulmonary Medicine

Törökbálint, , Hungary

Site Status

Zala Megyei Korhaz; Dept of Pulmonary Medicine

Zalaegerszeg, , Hungary

Site Status

Countries

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Hungary

References

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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.

Reference Type DERIVED
PMID: 30675234 (View on PubMed)

Other Identifiers

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ML21783

Identifier Type: -

Identifier Source: org_study_id