Lung AdenocarcinomaNCT02093000
A Study Examining Maintenance Bevacizumab (Avastin®) Monotherapy in Participants With Advanced Lung Adenocarcinoma
An observational study of Lung Adenocarcinoma, run by Hoffmann-La Roche at 16 sites in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Adenocarcinoma
- What is being tested?
- Bevacizumab
- Type of treatment
- Injection or infusion
- How many people
- 201 participants
- Where
- 16 sitesHungary
- Study dates
- 30 Nov 2014to 31 Jan 2018
- 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 receiving Avastin monotherapy as maintenance treatment
Who may be able to join
- 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
Who cannot join
- Participant who received the first cycle of maintenance bevacizumab more than 4 weeks after the postinduction tumor assessment
- Pregnant or breast-feeding
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Hungary16 sites
Orszagos Koranyi TBC es Pulmonologiai Intezet
Budapest, 1121
Semmelweis Egyetem X; Pulmonologiai Klinika
Budapest, 1125
Uzsoki Utcai Korhaz
Budapest, 1145
Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika
Debrecen, 4032
Csongrad Megyei Mellkasi Betegsegek Szakkorhaza
Deszk, 6772
Veszprem Megyei Onkormanyzat Tudogyogyintezet
Farkasgyepű, 8582
Petz Aladar Megyei Oktato Korhaz
Győr, 9024
Bekes Megyei Tudokorhaz; I. Tudobelosztaly
Gyula, 5703
Bacs-Kiskun Megyei Korhaz
Kecskemét, 6000
Matrai Gyogyintezet
Mátraháza, 3233
Szabolcs-Szatmar-Bereg County Josa Andras Hospital; 1St Depatment of Pulmonary Medicine
Nyíregyháza, 4400
University of Pecs; 1St Department of Medicine
Pécs, 7623
Fejer Megyei Szent Gyorgy Korhaz
Székesfehérvár, 8000
Vas Megyei Markusovszky Korhaz ; Oncoradiology
Szombathely, 9700
Komárom-Esztergom Megyei; Szent Borbála Kórháza
Tatabánya, 2800
Tudogyogyintezet Torokbalint
Törökbálint, 2045
About this study
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
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.
- Conditions
- Lung Adenocarcinoma
- Being tested
- Bevacizumab
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin®
Participants will receive bevacizumab 7.5 milligrams per kilograms (mg/kg) intravenously according to bevacizumab summary of product characteristics/local labeling.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS), Defined as Time From First Dose of Maintenance Avastin Treatment Until Disease progression or death from any cause
Measured: Baseline up to 40 months
Secondary outcomes (4)
PFS, defined as time from first dose of induction Avastin treatment until disease progression or death from any cause
Measured: Baseline up to 40 months
1-year overall survival defined as time from first dose of induction Avastin treatment until death from any cause
Measured: 12 months
Percentage of participants by best overall response
Measured: Baseline up to 40 months
Percentage of participants with adverse events
Measured: Baseline up to 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study start30 Nov 2014
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung AdenocarcinomaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 201 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
- NCT02093000
- Sponsor's protocol ID
- ML29261
- Status last verified
- Feb 2018
- First submitted
- 19 Mar 2014
- Last updated
- 23 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02093000
- Acronym / sponsor ID
- ML29261
- Conditions
- Lung Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2014 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 20 Mar 2014 (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, 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab | – | Drug: BevacizumabParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving Avastin monotherapy as maintenance treatment
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Participant who received the first cycle of maintenance bevacizumab more than 4 weeks after the postinduction tumor assessment
- Pregnant or breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: Avastin®Participants will receive bevacizumab 7.5 milligrams per kilograms (mg/kg) intravenously according to bevacizumab summary of product characteristics/local labeling. | Drug | Bevacizumab |
Primary outcome
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
4 secondary outcomes
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
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 23 Feb 2018.
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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
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Adenocarcinoma, run by Hoffmann-La Roche at 16 sites in Hungary.
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 3 inclusion and 2 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 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Hungary. 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 (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). 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 23 Feb 2018.