AVAdeno Study: An Observational Study of First-Line Avastin (Bevacizumab) in Patients With Adenocarcinoma of the Lung

Non-Squamous Non-Small Cell Lung Cancer Clinical Trial

Official title:

AVAdeno: Non-interventional Study of Avastin 1st Line Therapy in Adenocarcinoma Patients of the Lung

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01827852
• Other study ID #: ML28306
• Status: Completed
• Phase: N/A
• First received: April 2, 2013
• Last updated: July 25, 2017
• Start date: March 14, 2013
• Est. completion date: May 31, 2017

Study information

• Verified date: June 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This prospective observational study will evaluate the efficacy and safety of first-line Avastin (bevacizumab) in combination with platinum-based chemotherapy in different age groups (<60, 60-69, 70-79, >80 years) in patients with inoperable advanced, metastatic or recurrent adenocarcinoma non-small cell lung cancer. Patients will be followed for 18 months from the start of first-line therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1107
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Histologically confirmed inoperable advanced, metastatic or recurrent pre-dominantly non-squamous adenocarcinoma non-small cell lung cancer

Exclusion Criteria:

• Contraindications to Avastin treatment according to the Summary of Product Characteristics

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Non-Small-Cell Lung
• Non-Squamous Non-Small Cell Lung Cancer

Locations

Country	Name	City	State
Germany	Universität Leipzig; Medizinische Klinik und Poliklinik I, Abteilung Pneumologie	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival in 4 different age groups (<60, 60-69, 70-79, >/=80 years)		approximately 4.5 years
Secondary	Overall survival in 4 different age groups (<60, 60-69, 70-79, >/=80 years)		approximately 4.5 years
Secondary	Clinical/demographic patient characteristics at initiation of treatment		approximately 4.5 years
Secondary	Avastin treatment schedule in routine clinical practice (dosage/duration)		approximately 4 years
Secondary	Concomitant anti-neoplastic therapy (dosage/duration)		approximately 4.5 years
Secondary	Safety: Incidence of adverse events in 4 different age groups (<60, 60-69, 70-79, >/=80 years)		approximately 4.5 years