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)

May 26, 2017 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

150

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

  • Hungary
      • Budapest, Hungary, 1121
        • Orszagos Koranyi Tbc es Pulmonologiai Intezet
      • Budapest, Hungary, 1051
        • Ogyi, Orszagos Gyogyszereszeti Intezet
      • Budapest, Hungary, 1115
        • Szent Imre Hospital; Dept. of Oncology
      • Budapest, Hungary, 1122
        • Orszagos Onkologial Intezet; Onkologiai Osztaly X
      • Budapest, Hungary, 1125
        • Semmelweis Egyetem X; Pulmonologiai Klinika
      • Budapest, Hungary, 1145
        • Uzsoki Utcai Korhaz; Ii. Belgyogyaszat
      • Debrecen, Hungary, 4032
        • Debrecen Uni Medical School; Dept of Pulmonary Medicine
      • Debrecen, Hungary, H-4031
        • Hajdú-Bihar Megyei Önkormányzat Kenézy Gyula Hospital; Infektology Department
      • Deszk, Hungary, 6772
        • Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkórháza
      • Edeleny, Hungary, 3780
        • Koch Robert Korhaz
      • Farkasgyepu, Hungary, 8582
        • Megyei Tudogyogyintezet - Pulmonologia
      • Gyor, Hungary, 9023
        • Hospital of Aladar Petz; Dept of Oncoradiology
      • Gyula, Hungary, 5703
        • Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
      • Gyula, Hungary, 5703
        • Bekes Megyei Tudokorhaz; I. Tudobelosztaly
      • Győr, Hungary, 9024
        • Petz Aladár County Teaching Hospital; 2nd Department of Psychiatry
      • Kaposvar, Hungary, 7400
        • Kaposi Mor County Hospital; Dept. of Oncology
      • Kecskemet, Hungary, 6000
        • Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont
      • Miskolc, Hungary, 3529
        • Szent Ferenc Kórház; Belgyógyászat
      • Mosonmagyaróvár, Hungary, 9200
        • Karolina Korhaz
      • Mátraháza, Hungary, 3233
        • Matrai Állami Gyógyintézet ; Bronchológia
      • Nyiregyhaza, Hungary, 4400
        • Szabolcs-Szatmar-Bereg County Josa Andras Hospital; 1St Depatment of Pulmonary Medicine
      • Nyíregyháza, Hungary, 4400
        • Josa Andras Korhaz; Dept of Oncoradiology
      • Pecs, Hungary, 7623
        • Pécsi Tudományegyetem Áok; Onkoterapias Intezet
      • Pecs, Hungary, 7635
        • Baranya County Hospital; Pulmonology Dept
      • Sopron, Hungary, 9400
        • Sopron Megyei Jogu Varos Erzsebet Korhaza Mellkasgyogyaszat
      • Szekesfehervar, Hungary, 8001
        • Fejér Megyei Szent György Kórház; Pulmonary Medicine
      • Szekszard, Hungary, 7100
        • Tolna Megyei Balassa Janos Korhaz; Iv. Belgyogyaszati Osztaly
      • Szolnok, Hungary, 5004
        • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály
      • Szombathely, Hungary, 9700
        • Vas Megyei Markusovszky Korhaz ; Pulmonology
      • Szombathely, Hungary, 9700
        • Vas Megyei Markusovszky Korhaz ; Oncoradiology
      • Tatabánya, Hungary, 2800
        • Komarom-Esztergom Megyei Onkormanyzat Szent Borbala Korhaz; Haematologiai Osztaly
      • Torokbalint, Hungary, 2045
        • Inst. of Pulmonary Medicine, Torokbalint; 2Nd Dept of Pulmonary Medicine
      • Zalaegerszeg, Hungary, 8900
        • Zala Megyei Korhaz; Dept of Pulmonary Medicine

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

Sampling Method

Probability Sample

Study Population

Participants with locally advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology needing first-line treatment is observed.

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Bevacizumab
Bevacizumab is prescribed by physicians as per SPC.
Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Disease Progression
Time Frame: up to 45 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Tumor Response
Time Frame: Up to 45 months
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
Overall Survival
Time Frame: Up to 45 months
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
Number of Participants with Serious Adverse Events (SAEs) and Adverse Events (AEs)
Time Frame: Up to 45 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

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.

General Publications

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 (Actual)

June 17, 2008

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

May 26, 2017

First Submitted That Met QC Criteria

May 26, 2017

First Posted (Actual)

May 31, 2017

Study Record Updates

Last Update Posted (Actual)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 26, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML21783

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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