- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02596958
Safety and Efficacy Study of Avastin in Locally Advanced Metastatic or Recurrent Non-small Lung Cancer (NSLC) Participants
March 7, 2016 updated by: Hoffmann-La Roche
Available - Avastin in Addition to Platinum-based Chemotherapy is Indicated for First-lime Treatment of Patients With Locally Advanced, Metastatic or Recurrent Non-small Lung Cancer Other Than Predominantly Squamous Cell Histology
The purpose of this non-interventional study is the collection and documentation of data on safety and efficacy of intravenous (IV) bevacizumab (Avastin) in addition to platinum-based chemotherapy for first-line treatment in participants with unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology with focus on adenocarcinoma and elderly patients in daily routine.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
996
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Goslar, Germany, 38642
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell and with or without adenocarcinoma histology will be selected.
Description
Inclusion Criteria:
- Age greater than or equal to (>=) 18 years
- Histologically confirmed predominantly non-squamous NSCLC that is unresectably advanced, metastatic or recurrent (with or without adenocarcinoma)
- No contraindications to Avastin® according to the current Summary of Product Characteristics (SmPC) for Avastin®
- Therapeutic decision for Avastin® as first line treatment in combination with platinum-based chemotherapy was taken individually and independent of the non-interventional trial.
Exclusion Criteria:
N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Bevacizumab
Patients will receive six 3-weeks cycle of IV bevacizumab along with platinum-based chemotherapy, followed by maintenance therapy of bevacizumab until progression (approximately 7 months).
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Six 3-weeks cycle of IV bevacizumab will be administered for approximately 7 months.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Adverse Drug Reactions (ADRs), Toxicities, Avastin-Related ADRs, and Serious ADRs
Time Frame: Up to 74 months
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ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties.
Serious ADRs were defined as any untoward medical occurrence or effect that at any dose resulted in death or life-threatening conditions or required hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect or medically important condition.
Toxicity was defined as an adverse event that had an attribution (the relationship to investigational agent) of possible, probable or definite.
Avastin-related ADRs (an adverse event with a possible relationship or a relationship to the treatment with AVASTIN) were due to Avastin.
ADRs includes serious as well as non-serious ADRs.
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Up to 74 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Who Withdrew or Modified Treatment
Time Frame: Up to 74 months
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Percentage of participants who withdrew treatment or experienced at least 1 dose deviation in relation to the planned Avastin therapy were reported.
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Up to 74 months
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Number of Cycles of Systemic Therapy
Time Frame: Up to 74 months
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Number of cycles of systemic therapy was the mean number of cycles received by participants in combination therapy with Avastin and chemotherapy and with Avastin monotherapy (maintenance).
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Up to 74 months
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Percentage of Participants With Best Tumor Response Over Time
Time Frame: Up to 74 months
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Best tumor response (assessed as per clinical routine of the individual center) was categorized according to the following criteria at the investigator discretion: complete response (CR: commonly defined as disappearance of all target lesions, all non-target lesions, and no new lesion), partial response (PR: commonly defined as at least a 30 percent [%] decrease in the sum of the longest diameter [LD] of target lesions, no progression in non-target lesion, and no new lesion), stable disease (SD: commonly defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD], in addition to no new target lesions).
PD: commonly defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started and not evaluable (NE).
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Up to 74 months
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Percentage of Participants With Eastern Cooperative Group(ECOG) Performance Status Grades
Time Frame: Up to 74 months
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ECOG Performance Status measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on 5 point scale: 0 is equal to (=) fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than [>] 50% of waking hours [hrs]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead.
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Up to 74 months
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Percentage of Participants With Disease Control
Time Frame: Up to 74 months
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Disease control was defined as having achieved CR (commonly defined as disappearance of all target lesions, all non-target lesions, and no new lesion), PR (commonly defined as at least a 30% decrease in the sum of the LD of target lesions, no progression in non-target lesion, and no new lesion), or SD (commonly defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, in addition to no new target lesions) during the course of observation which were assessed as per investigator discretion.
PD: commonly defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started and NE.
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Up to 74 months
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Progression Free Survival (PFS)
Time Frame: Up to 74 months
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PFS was defined as the time (months) between the start of therapy and progression (unequivocal progression of existing non-target lesions) or death.
Progression: at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started.
PFS was estimated using Kaplan-Meier method.
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Up to 74 months
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Percentage of Participants Who Died
Time Frame: Up to 74 months
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Up to 74 months
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Overall Survival
Time Frame: Up to 74 months
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Overall survival was defined as the time (months) between the start of therapy and the date of death.
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Up to 74 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
November 3, 2015
First Submitted That Met QC Criteria
November 3, 2015
First Posted (Estimate)
November 4, 2015
Study Record Updates
Last Update Posted (Estimate)
April 4, 2016
Last Update Submitted That Met QC Criteria
March 7, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
Other Study ID Numbers
- ML21217
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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