Non-squamous Non-small Cell Lung CancerPhase 365plusNCT00976456
Efficacy Study of Avastin® With Pemetrexed +/- Carboplatin to Treat Elderly Patients With Non-small Cell Lung Cancer
A Phase 3 study testing Bevacizumab + Pemetrexed and Bevacizumab + Pemetrexed + Carboplatin in people with Non-squamous Non-small Cell Lung Cancer, run by PD Dr. med. Wolfgang Schuette at 1 site in Germany.
Trial summary
Multi-center, open, randomized (parallel) and comparative phase III. Eligible patients will receive bevacizumab + chemotherapy for a minimum of 4 cycles followed by bevacizumab (+ pemetrexed, if appropriate) maintenance therapy until disease progression. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Non-squamous Non-small Cell Lung Cancer
- What is being tested?
- Bevacizumab + Pemetrexed and Bevacizumab + Pemetrexed + Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2009to Oct 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Stage IIIb and IV NSCLC, excluded squamous cell NSCLC
- Age ≥ 65 years
- ECOG 0-2
Who cannot join
- Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component
- History of haemoptysis
- Evidence of tumour invading major blood vessels on imaging
- Radiotherapy within 28 days prior to enrolment
- Patients who are unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose ≤ 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam)
- Current or recent (within 10 days of first dose of bevacizumab) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. Prophylactic use of anticoagulants is allowed
Show all 9Show fewer
- Clinically significant (i.e. active) cardiovascular disease for example CVA (≤6 months before enrolment), myocardial infarction (≤6 months before enrolment), unstable angina, CHF NYHA Class ≥II, serious cardiac arrhythmia requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication
- Non-healing wound, active peptic ulcer or bone fracture
- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label Study of Bevacizumab (Avastin®) in Combination With Pemetrexed or Pemetrexed and Carboplatin as First-line Treatment of Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer
Multi-center, open, randomized (parallel) and comparative phase III.
Eligible patients will receive bevacizumab + chemotherapy for a minimum of 4 cycles followed by bevacizumab (+ pemetrexed, if appropriate) maintenance therapy until disease progression.
Arm A: Bevacizumab + pemetrexed
Arm B: Bevacizumab + pemetrexed + carboplatin
Read the detailed description
Primary:
- Proof of non-inferior efficacy of a monochemotherapy regimen of pemetrexed plus bevacizumab versus a combination chemotherapy regimen of pemetrexed-carboplatin plus bevacizumab in elderly patients(> 65 years) as first-line treatment of advanced metastatic or recurrent non-squamous NSCLC by progression free survival
Secondary:
- To assess the efficacy of bevacizumab as measured by overall response rate and overall survival.
- To assess the safety of bevacizumab in combination with pemetrexed and pemetrexed and carboplatin.
- To assess quality of life by EORTC questionnaire QLQ-C30 and its lung cancer module LC-13
- To assess activity of daily life (iADL) in relation to ECOG performance status prior to study treatment
- To assess patient's outcome and treatment delivery in relation to the Charlson comorbidity score and the Simplified Comorbidity Score
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Being tested
- Bevacizumab + Pemetrexed, Bevacizumab + Pemetrexed + Carboplatin
- Keywords
- lung cancer, NSCLC, elderly, non-squamous, Elderly patients at least 65 years old, first line therapy, non-squamous non-small cell lung cancer stage IIIb or IV
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab + PemetrexedDrug
Also called Avastin®, ALIMTA®
Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks
Bevacizumab + Pemetrexed + CarboplatinDrug
Also called Avastin®, ALIMTA®, Carboplatin
Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab + Pemetrexed | Active comparator | Bevacizumab + Pemetrexed Receives: Drug: Bevacizumab + Pemetrexed |
| Bevacizumab + Pemetrexed + Carboplatin | Active comparator | Bevacizumab + Pemetrexed + Carboplatin Receives: Drug: Bevacizumab + Pemetrexed + Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Progression free survival (defined as the number of days from the day of the first treatment until day of death (from any cause) or progression, whichever occurs earlier, or until the day of the last response assessment, if no progression or death (from any cause) is observed during the study).
Measured: 42 months
Secondary outcomes (1)
Overall Survival
Overall survival (defined as the number of days from the day of first treatment to death (from any cause), or until the last day if we know that the patient is alive).
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-squamous Non-small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- PD Dr. med. Wolfgang Schuette
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG, Eli Lilly and Company
- Responsible party
- Sponsor-investigator, PD Dr. med. Wolfgang Schuette, Martha-Maria Krankenhaus Halle-Dölau gGmbH
- Investigators
- Wolfgang Schuette, PhD MD., Study chair, Krankenhaus Martha-Maria Halle-Doelau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976456
- Sponsor's protocol ID
- 65 plus
- Other IDs
- ML21896
- Acronym
- 65plus
- Status last verified
- Feb 2016
- First submitted
- 11 Sep 2009
- Last updated
- 10 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Study of Bevacizumab (Avastin®) in Combination With Pemetrexed or Pemetrexed and Carboplatin as First-line Treatment of Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00976456
- Acronym / sponsor ID
- 65plus / 65 plus
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Keywords
- lung cancer, NSCLC, elderly, non-squamous, Elderly patients at least 65 years old, first line therapy, non-squamous non-small cell lung cancer stage IIIb or IV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- PD Dr. med. Wolfgang SchuetteUniversity, hospital or other
- Collaborators
- Roche Pharma AG, Eli Lilly and Company
- Study start
- Sep 2009
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 14 Sep 2009 (estimated)
- Results
- Posted 10 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multi-center, open, randomized (parallel) and comparative phase III.
Eligible patients will receive bevacizumab + chemotherapy for a minimum of 4 cycles followed by bevacizumab (+ pemetrexed, if appropriate) maintenance therapy until disease progression.
Arm A: Bevacizumab + pemetrexed
Arm B: Bevacizumab + pemetrexed + carboplatin
Detailed description
Primary:
- Proof of non-inferior efficacy of a monochemotherapy regimen of pemetrexed plus bevacizumab versus a combination chemotherapy regimen of pemetrexed-carboplatin plus bevacizumab in elderly patients(> 65 years) as first-line treatment of advanced metastatic or recurrent non-squamous NSCLC by progression free survival
Secondary:
- To assess the efficacy of bevacizumab as measured by overall response rate and overall survival.
- To assess the safety of bevacizumab in combination with pemetrexed and pemetrexed and carboplatin.
- To assess quality of life by EORTC questionnaire QLQ-C30 and its lung cancer module LC-13
- To assess activity of daily life (iADL) in relation to ECOG performance status prior to study treatment
- To assess patient's outcome and treatment delivery in relation to the Charlson comorbidity score and the Simplified Comorbidity Score
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab + Pemetrexed | Active comparator | Drug: Bevacizumab + PemetrexedBevacizumab + Pemetrexed |
| Bevacizumab + Pemetrexed + Carboplatin | Active comparator | Drug: Bevacizumab + Pemetrexed + CarboplatinBevacizumab + Pemetrexed + Carboplatin |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Stage IIIb and IV NSCLC, excluded squamous cell NSCLC
- Age ≥ 65 years
- ECOG 0-2
Key exclusion criteria (9 listed)
- Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component
- History of haemoptysis
- Evidence of tumour invading major blood vessels on imaging
- Radiotherapy within 28 days prior to enrolment
- Patients who are unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose ≤ 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam)
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 |
|---|---|---|
| Bevacizumab + PemetrexedAlso: Avastin®, ALIMTA®Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks | Drug | Bevacizumab + Pemetrexed |
| Bevacizumab + Pemetrexed + CarboplatinAlso: Avastin®, ALIMTA®, CarboplatinBevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks | Drug | Bevacizumab + Pemetrexed + Carboplatin |
Primary outcome
Progression Free Survival
Time frame: 42 months
Progression free survival (defined as the number of days from the day of the first treatment until day of death (from any cause) or progression, whichever occurs earlier, or until the day of the last response assessment, if no progression or death (from any cause) is observed during the study).
1 secondary outcome
Overall Survival
Time frame: 42 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Wolfgang Schuette, PhD MD. study chair
Krankenhaus Martha-Maria Halle-Doelau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bevacizumab + Pemetrexed and Bevacizumab + Pemetrexed + Carboplatin in people with Non-squamous Non-small Cell Lung Cancer, run by PD Dr. med. Wolfgang Schuette 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 3 inclusion and 9 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 10 Mar 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (time frame: 42 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 10 Mar 2016.