Non-Squamous Non-Small Cell Lung CancerNCT01827852
AVAdeno Study: An Observational Study of First-Line Avastin (Bevacizumab) in Patients With Adenocarcinoma of the Lung
An observational study of Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Squamous Non-Small Cell Lung Cancer
- How many people
- 1,107 participants
- Where
- 1 siteGermany
- Study dates
- 14 Mar 2013to 31 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with inoperable advanced, metastatic or recurrent predominantly non-squamous adenocarcinoma non-small cell lung cancer
Who may be able to join
- Adult patients, >/= 18 years of age
- Histologically confirmed inoperable advanced, metastatic or recurrent pre-dominantly non-squamous adenocarcinoma non-small cell lung cancer
Who cannot join
- Contraindications to Avastin treatment according to the Summary of Product Characteristics
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universität Leipzig; Medizinische Klinik und Poliklinik I, Abteilung Pneumologie
Leipzig, 04103
About this study
Official title: AVAdeno: Non-interventional Study of Avastin 1st Line Therapy in Adenocarcinoma Patients of the Lung
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.
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival in 4 different age groups (<60, 60-69, 70-79, >/=80 years)
Measured: approximately 4.5 years
Secondary outcomes (5)
Overall survival in 4 different age groups (<60, 60-69, 70-79, >/=80 years)
Measured: approximately 4.5 years
Clinical/demographic patient characteristics at initiation of treatment
Measured: approximately 4.5 years
Avastin treatment schedule in routine clinical practice (dosage/duration)
Measured: approximately 4 years
Concomitant anti-neoplastic therapy (dosage/duration)
Measured: approximately 4.5 years
Safety: Incidence of adverse events in 4 different age groups (<60, 60-69, 70-79, >/=80 years)
Measured: approximately 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study start14 Mar 2013
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Squamous Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01827852
- Sponsor's protocol ID
- ML28306
- Status last verified
- Jun 2017
- First submitted
- 2 Apr 2013
- Last updated
- 28 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AVAdeno: Non-interventional Study of Avastin 1st Line Therapy in Adenocarcinoma Patients of the Lung
- ClinicalTrials.gov ID
- NCT01827852
- Acronym / sponsor ID
- ML28306
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,107 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2013 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 10 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with inoperable advanced, metastatic or recurrent predominantly non-squamous adenocarcinoma non-small cell lung cancer
Key inclusion criteria (2 listed)
- Adult patients, >/= 18 years of age
- Histologically confirmed inoperable advanced, metastatic or recurrent pre-dominantly non-squamous adenocarcinoma non-small cell lung cancer
Key exclusion criteria (1 listed)
- Contraindications to Avastin treatment according to the Summary of Product Characteristics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-free survival in 4 different age groups (<60, 60-69, 70-79, >/=80 years)
Time frame: approximately 4.5 years
5 secondary outcomes
Overall survival in 4 different age groups (<60, 60-69, 70-79, >/=80 years)
Time frame: approximately 4.5 years
Clinical/demographic patient characteristics at initiation of treatment
Time frame: approximately 4.5 years
Avastin treatment schedule in routine clinical practice (dosage/duration)
Time frame: approximately 4 years
Concomitant anti-neoplastic therapy (dosage/duration)
Time frame: approximately 4.5 years
Safety: Incidence of adverse events in 4 different age groups (<60, 60-69, 70-79, >/=80 years)
Time frame: approximately 4.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival in 4 different age groups (<60, 60-69, 70-79, >/=80 years) (time frame: approximately 4.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017.