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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 17, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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