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AzTrials

Carcinoma, Non-Small-Cell LungAVALANCHENCT03170284

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

An observational study of Carcinoma, Non-Small-Cell Lung, run by Hoffmann-La Roche at 33 sites in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Bevacizumab
Type of treatment
Injection or infusion
How many people
150 participants
Where
33 sitesHungary
Study dates
17 Jun 2008to 1 Aug 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

Hungary33 sites

  • Ogyi, Orszagos Gyogyszereszeti Intezet

    Budapest, 1051

  • Szent Imre Hospital; Dept. of Oncology

    Budapest, 1115

  • Orszagos Koranyi TBC es Pulmonologiai Intezet

    Budapest, 1121

  • Orszagos Onkologial Intezet; Onkologiai Osztaly X

    Budapest, 1122

  • Semmelweis Egyetem X; Pulmonologiai Klinika

    Budapest, 1125

  • Uzsoki Utcai Korhaz; Ii. Belgyogyaszat

    Budapest, 1145

  • Debrecen Uni Medical School; Dept of Pulmonary Medicine

    Debrecen, 4032

  • Hajdú-Bihar Megyei Önkormányzat Kenézy Gyula Hospital; Infektology Department

    Debrecen, H-4031

  • Csongrad Megyei Onkormanyzat Mellkasi Betegsegek Szakkorhaza

    Deszk, 6772

  • Koch Robert Korhaz

    Edelény, 3780

  • Megyei Tudogyogyintezet - Pulmonologia

    Farkasgyepű, 8582

  • Hospital of Aladar Petz; Dept of Oncoradiology

    Győr, 9023

  • Petz Aladár County Teaching Hospital; 2nd Department of Psychiatry

    Győr, 9024

  • Bekes Megyei Tudokorhaz; I. Tudobelosztaly

    Gyula, 5703

  • Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek

    Gyula, 5703

  • Kaposi Mor County Hospital; Dept. of Oncology

    Kaposvár, 7400

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

    Kecskemét, 6000

  • Matrai Állami Gyógyintézet ; Bronchológia

    Mátraháza, 3233

  • Szent Ferenc Kórház; Belgyógyászat

    Miskolc, 3529

  • Karolina Korhaz

    Mosonmagyaróvár, 9200

  • Josa Andras Korhaz; Dept of Oncoradiology

    Nyíregyháza, 4400

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

    Nyíregyháza, 4400

  • Pécsi Tudományegyetem Áok; Onkoterapias Intezet

    Pécs, 7623

  • Baranya County Hospital; Pulmonology Dept

    Pécs, 7635

  • Sopron Megyei Jogu Varos Erzsebet Korhaza Mellkasgyogyaszat

    Sopron, 9400

  • Fejér Megyei Szent György Kórház; Pulmonary Medicine

    Székesfehérvár, 8001

  • Tolna Megyei Balassa Janos Korhaz; Iv. Belgyogyaszati Osztaly

    Szekszárd, 7100

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

    Szolnok, 5004

  • Vas Megyei Markusovszky Korhaz ; Oncoradiology

    Szombathely, 9700

  • Vas Megyei Markusovszky Korhaz ; Pulmonology

    Szombathely, 9700

  • Komarom-Esztergom Megyei Onkormanyzat Szent Borbala Korhaz; Haematologiai Osztaly

    Tatabánya, 2800

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

    Törökbálint, 2045

  • Zala Megyei Korhaz; Dept of Pulmonary Medicine

    Zalaegerszeg, 8900

Other trials in Hungary

About this study

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

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.

Being tested
Bevacizumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab is prescribed by physicians as per SPC.

Study groups in NCT03170284
Study groupRoleWhat they receive
BevacizumabParticipants with advanced (stage IIIB/IV) NSCLC other than predominantly squamous cell histology receiving Bevacizumab in accordance with the summary product characteristics (SPC) is observed.
Receives: Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 45 months

Secondary outcomes (3)

  1. 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.

    Measured: Up to 45 months

  2. 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.

    Measured: Up to 45 months

  3. 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.

    Measured: Up to 45 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2017
  2. Study start17 Jun 2008
  3. Primary completion1 Aug 2012
  4. Study completion1 Aug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03170284
Sponsor's protocol ID
ML21783
Acronym
AVALANCHE
Status last verified
May 2017
First submitted
26 May 2017
Last updated
31 May 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 30675234

Questions about this trial

What is this clinical trial studying?

An observational study of Carcinoma, Non-Small-Cell Lung, run by Hoffmann-La Roche at 33 sites in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Disease Progression (time frame: up to 45 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03170284, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.

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