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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02093000
Recruitment Status : Completed
First Posted : March 20, 2014
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date March 19, 2014
First Posted Date March 20, 2014
Last Update Posted Date February 23, 2018
Actual Study Start Date November 30, 2014
Actual Primary Completion Date January 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 1, 2017)
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 ]
Original Primary Outcome Measures
 (submitted: March 19, 2014)
Progression-free survival (PFS), defined as time from first dose of maintenance Avastin treatment until disease progression or death from any cause. [ Time Frame: Up to 34 months ]
Change History
Current Secondary Outcome Measures
 (submitted: December 1, 2017)
  • 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 ]
  • 1-year overall survival defined as time from first dose of induction Avastin treatment until death from any cause [ Time Frame: 12 months ]
  • Percentage of participants by best overall response [ Time Frame: Baseline up to 40 months ]
  • Percentage of participants with adverse events [ Time Frame: Baseline up to 40 months ]
Original Secondary Outcome Measures
 (submitted: March 19, 2014)
  • PFS, defined as time from first dose of induction Avastin treatment until disease progression or death from any cause. [ Time Frame: Up to 34 months ]
  • 1 year overall survival defined as time from first dose of induction Avastin treatment until death from any cause. [ Time Frame: 12 months ]
  • Best overall response [ Time Frame: Up to 34 months ]
  • Incidence of adverse events [ Time Frame: Up to 34 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients receiving Avastin monotherapy as maintenance treatment
Condition Lung Adenocarcinoma
Intervention Drug: Bevacizumab
Participants will receive bevacizumab 7.5 milligrams per kilograms (mg/kg) intravenously according to bevacizumab summary of product characteristics/local labeling.
Other Name: Avastin®
Study Groups/Cohorts Bevacizumab
Participants who have received the induction phase of 4-6 cycles of bevacizumab plus platinum doublet chemotherapy will be treated with bevacizumab as maintenance treatment, according to approved label and local reimbursement.
Intervention: Drug: Bevacizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 22, 2018)
201
Original Estimated Enrollment
 (submitted: March 19, 2014)
200
Actual Study Completion Date January 31, 2018
Actual Primary Completion Date January 31, 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Hungary
Removed Location Countries  
 
Administrative Information
NCT Number NCT02093000
Other Study ID Numbers ML29261
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor Hoffmann-La Roche
Collaborators Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date February 2018