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
- Registration Number
- NCT03170284
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
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
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Bevacizumab 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.
- Primary Outcome Measures
Name Time Method Time to Disease Progression 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.
- Secondary Outcome Measures
Name Time Method Best Tumor Response 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.
Overall Survival 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.
Number of Participants with Serious Adverse Events (SAEs) and Adverse Events (AEs) 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.
Trial Locations
- Locations (33)
Szent Imre Hospital; Dept. of Oncology
🇭🇺Budapest, Hungary
Fejér Megyei Szent György Kórház; Pulmonary Medicine
🇭🇺Szekesfehervar, Hungary
Debrecen Uni Medical School; Dept of Pulmonary Medicine
🇭🇺Debrecen, Hungary
Karolina Korhaz
🇭🇺Mosonmagyaróvár, Hungary
Pécsi Tudományegyetem Áok; Onkoterapias Intezet
🇭🇺Pecs, Hungary
Semmelweis Egyetem X; Pulmonologiai Klinika
🇭🇺Budapest, Hungary
Uzsoki Utcai Korhaz; Ii. Belgyogyaszat
🇭🇺Budapest, Hungary
Hajdú-Bihar Megyei Önkormányzat Kenézy Gyula Hospital; Infektology Department
🇭🇺Debrecen, Hungary
Bekes Megyei Tudokorhaz; I. Tudobelosztaly
🇭🇺Gyula, Hungary
Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont
🇭🇺Kecskemet, Hungary
Baranya County Hospital; Pulmonology Dept
🇭🇺Pecs, Hungary
Komarom-Esztergom Megyei Onkormanyzat Szent Borbala Korhaz; Haematologiai Osztaly
🇭🇺Tatabánya, Hungary
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály
🇭🇺Szolnok, Hungary
Inst. of Pulmonary Medicine, Torokbalint; 2Nd Dept of Pulmonary Medicine
🇭🇺Torokbalint, Hungary
Zala Megyei Korhaz; Dept of Pulmonary Medicine
🇭🇺Zalaegerszeg, Hungary
Petz Aladár County Teaching Hospital; 2nd Department of Psychiatry
🇭🇺Győr, Hungary
Kaposi Mor County Hospital; Dept. of Oncology
🇭🇺Kaposvar, Hungary
Matrai Állami Gyógyintézet ; Bronchológia
🇭🇺Mátraháza, Hungary
Szabolcs-Szatmar-Bereg County Josa Andras Hospital; 1St Depatment of Pulmonary Medicine
🇭🇺Nyiregyhaza, Hungary
Vas Megyei Markusovszky Korhaz ; Oncoradiology
🇭🇺Szombathely, Hungary
Vas Megyei Markusovszky Korhaz ; Pulmonology
🇭🇺Szombathely, Hungary
Orszagos Koranyi TBC es Pulmonologiai Intezet
🇭🇺Budapest, Hungary
Sopron Megyei Jogu Varos Erzsebet Korhaza Mellkasgyogyaszat
🇭🇺Sopron, Hungary
Tolna Megyei Balassa Janos Korhaz; Iv. Belgyogyaszati Osztaly
🇭🇺Szekszard, Hungary
Megyei Tudogyogyintezet - Pulmonologia
🇭🇺Farkasgyepu, Hungary
Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
🇭🇺Gyula, Hungary
Csongrad Megyei Onkormanyzat Mellkasi Betegsegek Szakkorhaza
🇭🇺Deszk, Hungary
Koch Robert Korhaz
🇭🇺Edeleny, Hungary
Josa Andras Korhaz; Dept of Oncoradiology
🇭🇺Nyíregyháza, Hungary
Hospital of Aladar Petz; Dept of Oncoradiology
🇭🇺Gyor, Hungary
Szent Ferenc Kórház; Belgyógyászat
🇭🇺Miskolc, Hungary
Ogyi, Orszagos Gyogyszereszeti Intezet
🇭🇺Budapest, Hungary
Orszagos Onkologial Intezet; Onkologiai Osztaly X
🇭🇺Budapest, Hungary