Advanced Non-small Cell Lung CancerPhase 2NCT02200354
The Safety and Efficacy of Pemetrexed Rechallenge With Bevacizumab
A Phase 2 study testing pemetrexed with bevacizumab in people with Advanced Non-small Cell Lung Cancer, run by Kobe City General Hospital at 1 site in Japan.
Trial summary
For patients with nonsquamous NSCLC and a good performance status (PS), pemetrexed and cisplatin has been recommended for first-line NSCLC treatment. Recently, results from the PARAMOUNT trial showed that patients with nonsquamous NSCLC who had a good PS and had not progressed after completing four cycles of… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Non-small Cell Lung Cancer
- What is being tested?
- pemetrexed with bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2014to 20 Mar 2019
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 Years and older
- PS0-2
- Advanced non-squamous non-small cell lung cancer; AND
- Patients who have received more than 4 cycles of pemetrexed therapy before the study
Who cannot join
- Interstitial pneumonia; AND
- Abnormal blood test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety and Efficacy of Pemetrexed Rechallenge With Bevacizumab for Patients With Advanced Non-squamous Non-small Cell Lung Cancer
For patients with nonsquamous NSCLC and a good performance status (PS), pemetrexed and cisplatin has been recommended for first-line NSCLC treatment. Recently, results from the PARAMOUNT trial showed that patients with nonsquamous NSCLC who had a good PS and had not progressed after completing four cycles of pemetrexed-cisplatin induction therapy benefitted from pemetrexed continuation maintenance therapy. Furthermore, pemetrexed with bevacizumab continuous maintenance might be better treatment option, considering the results from AVAPEARL trial. Pemetrexed rechallenge has been reported to be effective in some patients. Therefore, in order to investigate the safety and efficacy of pemetrexed rechallenge with bevacizumab,we conducted this study.
- Conditions
- Advanced Non-small Cell Lung Cancer
- Being tested
- pemetrexed with bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pemetrexed with bevacizumabDrug
| Study group | Role | What they receive |
|---|---|---|
| pemetrexed with bevacizumab | Experimental | pemetrexed rechallenge with bevacizumab pemetrexed (500mg/m2 day1) bevacizumab (15mg/kg day1) Receives: Drug: pemetrexed with bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
Measured: Within the study period and until tumor proression, an expected average of 16 weeks
Secondary outcomes (4)
response rate
Measured: The response will be assessed while participants received the pemetrexed with bevacizumab, an expected average to the maximum response of 4 - 16 weeks
overall survival
Measured: From date of the start of pemetrexed with bevacizumab until date of death from any cause, up to 3 years
time to treatment failure (TTF)
Measured: From date of the start of pemetrexed with bevacizumab until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Number of Participants with Adverse Events
Measured: From date of the start of pemetrexed with bevacizumab until the participants stop this therapy, an expected average of 16 weeks and up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startJul 2014
- Primary completion20 Mar 2018
- Study completion20 Mar 2019
Why it stopped: inclusion speed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kobe City General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daichi Fujimoto, Kobe City General Hospital
- Investigators
- Daichi Fujimoto, MD, Principal investigator, Kobe City Medical Center General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200354
- Sponsor's protocol ID
- PEM-RE-2014
- Status last verified
- Aug 2019
- First submitted
- 20 Jul 2014
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Pemetrexed Rechallenge With Bevacizumab for Patients With Advanced Non-squamous Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02200354
- Acronym / sponsor ID
- PEM-RE-2014
- Conditions
- Advanced Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inclusion speed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kobe City General HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 20 Mar 2018 (actual)
- Study completion
- 20 Mar 2019 (actual)
- First posted
- 25 Jul 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.
For patients with nonsquamous NSCLC and a good performance status (PS), pemetrexed and cisplatin has been recommended for first-line NSCLC treatment. Recently, results from the PARAMOUNT trial showed that patients with nonsquamous NSCLC who had a good PS and had not progressed after completing four cycles of pemetrexed-cisplatin induction therapy benefitted from pemetrexed continuation maintenance therapy. Furthermore, pemetrexed with bevacizumab continuous maintenance might be better treatment option, considering the results from AVAPEARL trial. Pemetrexed rechallenge has been reported to be effective in some patients. Therefore, in order to investigate the safety and efficacy of pemetrexed rechallenge with bevacizumab,we conducted this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pemetrexed with bevacizumab | Experimental | Drug: pemetrexed with bevacizumabpemetrexed rechallenge with bevacizumab pemetrexed (500mg/m2 day1) bevacizumab (15mg/kg day1) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 20 Years and older
- PS0-2
- Advanced non-squamous non-small cell lung cancer; AND
- Patients who have received more than 4 cycles of pemetrexed therapy before the study
Key exclusion criteria (2 listed)
- Interstitial pneumonia; AND
- Abnormal blood test
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 |
|---|---|---|
| pemetrexed with bevacizumab | Drug | pemetrexed with bevacizumab |
Primary outcome
progression free survival
Time frame: Within the study period and until tumor proression, an expected average of 16 weeks
4 secondary outcomes
response rate
Time frame: The response will be assessed while participants received the pemetrexed with bevacizumab, an expected average to the maximum response of 4 - 16 weeks
overall survival
Time frame: From date of the start of pemetrexed with bevacizumab until date of death from any cause, up to 3 years
time to treatment failure (TTF)
Time frame: From date of the start of pemetrexed with bevacizumab until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Number of Participants with Adverse Events
Time frame: From date of the start of pemetrexed with bevacizumab until the participants stop this therapy, an expected average of 16 weeks and up to 3 years
Results and safety
The study was stopped early (reason given: inclusion speed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
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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.
Daichi Fujimoto, MD principal investigator
Kobe City Medical Center General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pemetrexed with bevacizumab in people with Advanced Non-small Cell Lung Cancer, run by Kobe City General Hospital at 1 site in Japan.
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 4 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: stopped early, as of the sponsor's last update on 14 Aug 2019. 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 Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: inclusion speed). Results are not available in the source record.
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: Within the study period and until tumor proression, an expected average of 16 weeks). 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 14 Aug 2019.