Clinical trial NCT02093000: A Study Examining Maintenance Bevacizumab (Avastin®) Monotherapy in Participants With Advanced Lung Adenocarcinoma
Official title: A Multicenter, Prospective, Non-interventional Study of Maintenance Avastin® (Bevacizumab) Following Induction Treatment With Platinum Doublet Plus Avastin® in Patients With Advanced Lung Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Adenocarcinoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-03-20
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving Avastin monotherapy as maintenance treatment

Brief summary: This prospective, open-label, single arm, non-interventional study will investigate the effectiveness of bevacizumab monotherapy in participants with lung adenocarcinoma who previously received 4 to 6 cycles of induction platinum doublet plus bevacizumab.


Eligibility criteria: Inclusion Criteria:

* Participant who previously received 4 to 6 cycles of induction platinum doublet plus bevacizumab
* Participant who received only 1 cycle of bevacizumab maintenance treatment
* Meet summary of product characteristics guidelines

Exclusion Criteria:

* Participant who received the first cycle of maintenance bevacizumab more than 4 weeks after the postinduction tumor assessment
* Pregnant or breast-feeding

Primary outcomes:
measure: Progression-Free Survival (PFS), Defined as Time From First Dose of Maintenance Avastin Treatment Until Disease progression or death from any cause
timeFrame: Baseline up to 40 months
Secondary outcomes:
measure: PFS, defined as time from first dose of induction Avastin treatment until disease progression or death from any cause
timeFrame: Baseline up to 40 months
measure: 1-year overall survival defined as time from first dose of induction Avastin treatment until death from any cause
timeFrame: 12 months
measure: Percentage of participants by best overall response
timeFrame: Baseline up to 40 months
measure: Percentage of participants with adverse events
timeFrame: Baseline up to 40 months
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Orszagos Koranyi TBC es Pulmonologiai Intezet
city: Budapest
country: Hungary
facility: Semmelweis Egyetem X; Pulmonologiai Klinika
city: Budapest
country: Hungary
facility: Uzsoki Utcai Korhaz
city: Debrecen
country: Hungary
facility: Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika
city: Deszk
country: Hungary
facility: Csongrad Megyei Mellkasi Betegsegek Szakkorhaza
city: Farkasgyepu
country: Hungary
facility: Veszprem Megyei Onkormanyzat Tudogyogyintezet
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz
city: Gyula
country: Hungary
facility: Bekes Megyei Tudokorhaz; I. Tudobelosztaly
city: Kecskemet
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz
city: Matrahaza
country: Hungary
facility: Matrai Gyogyintezet
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg County Josa Andras Hospital; 1St Depatment of Pulmonary Medicine
city: Pecs
country: Hungary
facility: University of Pecs; 1St Department of Medicine
city: Szekesfehervar
country: Hungary
facility: Fejer Megyei Szent Gyorgy Korhaz
city: Szombathely
country: Hungary
facility: Vas Megyei Markusovszky Korhaz ; Oncoradiology
city: Tatabánya
country: Hungary
facility: Komárom-Esztergom Megyei; Szent Borbála Kórháza
city: Torokbalint
country: Hungary
facility: Tudogyogyintezet Torokbalint
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: