Clinical trial NCT03170284: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-05-31
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to Disease Progression
timeFrame: up to 45 months
Secondary outcomes:
measure: Best Tumor Response
timeFrame: Up to 45 months
measure: Overall Survival
timeFrame: Up to 45 months
measure: Number of Participants with Serious Adverse Events (SAEs) and Adverse Events (AEs)
timeFrame: Up to 45 months
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Ogyi, Orszagos Gyogyszereszeti Intezet
city: Budapest
country: Hungary
facility: Szent Imre Hospital; Dept. of Oncology
city: Budapest
country: Hungary
facility: Orszagos Koranyi TBC es Pulmonologiai Intezet
city: Budapest
country: Hungary
facility: Orszagos Onkologial Intezet; Onkologiai Osztaly X
city: Budapest
country: Hungary
facility: Semmelweis Egyetem X; Pulmonologiai Klinika
city: Budapest
country: Hungary
facility: Uzsoki Utcai Korhaz; Ii. Belgyogyaszat
city: Debrecen
country: Hungary
facility: Debrecen Uni Medical School; Dept of Pulmonary Medicine
city: Debrecen
country: Hungary
facility: Hajdú-Bihar Megyei Önkormányzat Kenézy Gyula Hospital; Infektology Department
city: Deszk
country: Hungary
facility: Csongrad Megyei Onkormanyzat Mellkasi Betegsegek Szakkorhaza
city: Edeleny
country: Hungary
facility: Koch Robert Korhaz
city: Farkasgyepu
country: Hungary
facility: Megyei Tudogyogyintezet - Pulmonologia
city: Gyor
country: Hungary
facility: Hospital of Aladar Petz; Dept of Oncoradiology
city: Gyula
country: Hungary
facility: Bekes Megyei Tudokorhaz; I. Tudobelosztaly
city: Gyula
country: Hungary
facility: Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
city: Győr
country: Hungary
facility: Petz Aladár County Teaching Hospital; 2nd Department of Psychiatry
city: Kaposvar
country: Hungary
facility: Kaposi Mor County Hospital; Dept. of Oncology
city: Kecskemet
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont
city: Miskolc
country: Hungary
facility: Szent Ferenc Kórház; Belgyógyászat
city: Mosonmagyaróvár
country: Hungary
facility: Karolina Korhaz
city: Mátraháza
country: Hungary
facility: Matrai Állami Gyógyintézet ; Bronchológia
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg County Josa Andras Hospital; 1St Depatment of Pulmonary Medicine
city: Nyíregyháza
country: Hungary
facility: Josa Andras Korhaz; Dept of Oncoradiology
city: Pecs
country: Hungary
facility: Pécsi Tudományegyetem Áok; Onkoterapias Intezet
city: Pecs
country: Hungary
facility: Baranya County Hospital; Pulmonology Dept
city: Sopron
country: Hungary
facility: Sopron Megyei Jogu Varos Erzsebet Korhaza Mellkasgyogyaszat
city: Szekesfehervar
country: Hungary
facility: Fejér Megyei Szent György Kórház; Pulmonary Medicine
city: Szekszard
country: Hungary
facility: Tolna Megyei Balassa Janos Korhaz; Iv. Belgyogyaszati Osztaly
city: Szolnok
country: Hungary
facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály
city: Szombathely
country: Hungary
facility: Vas Megyei Markusovszky Korhaz ; Oncoradiology
city: Szombathely
country: Hungary
facility: Vas Megyei Markusovszky Korhaz ; Pulmonology
city: Tatabánya
country: Hungary
facility: Komarom-Esztergom Megyei Onkormanyzat Szent Borbala Korhaz; Haematologiai Osztaly
city: Torokbalint
country: Hungary
facility: Inst. of Pulmonary Medicine, Torokbalint; 2Nd Dept of Pulmonary Medicine
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Korhaz; Dept of Pulmonary Medicine
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.