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OpenTrials
Completed

NCT Number: NCT02093000

A Study Examining Maintenance Bevacizumab (Avastin®) Monotherapy in Participants With Advanced Lung Adenocarcinoma

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.

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Key information

Conditions

Lung Adenocarcinoma Adenocarcinoma Adenocarcinoma of Lung Carcinoma Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Orszagos Koranyi TBC es Pulmonologiai Intezet, Budapest, Hungary

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

Drug

Participants will receive bevacizumab 7.5 milligrams per kilograms (mg/kg) intravenously according to bevacizumab summary of product characteristics/local labeling.

Other names: Avastin®

Primary outcomes

  1. Progression-Free Survival (PFS), Defined as Time From First Dose of Maintenance Avastin Treatment Until Disease progression or death from any cause

    Time frame: Baseline up to 40 months

Secondary outcomes

  1. PFS, defined as time from first dose of induction Avastin treatment until disease progression or death from any cause

    Time frame: Baseline up to 40 months

  2. 1-year overall survival defined as time from first dose of induction Avastin treatment until death from any cause

    Time frame: 12 months

  3. Percentage of participants by best overall response

    Time frame: Baseline up to 40 months

  4. Percentage of participants with adverse events

    Time frame: Baseline up to 40 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 20, 2014
Registry last updated
Feb 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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