Previous Treated Metastatic Non-small Cell Lung CancerPhase 2NCT01783834
Gefitinib Versus Pemetrexed for Previously Treated NSCLC Patients
A Phase 2 study testing Gefitinib and Pemetrexed in people with Previous Treated Metastatic Non-small Cell Lung Cancer, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
To compare the efficacy of gefitinib versus pemetrexed as second-line chemotherapy for patients with previous treated non-small cell lung cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Previous Treated Metastatic Non-small Cell Lung Cancer
- What is being tested?
- Gefitinib and Pemetrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2008to Jun 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cells pathologically diagnosed as histological or radical surgery or radiation therapy is not possible stage IIIB and stage IV non-small-cell lung cancer patients
- second line
- ECOG 0～2
- Patients with normal liver function and renal function
Who cannot join
- Patients with severe acute infection requiring antibiotic therapy
- Patients who have received treatment in other areas of cancer within 5 years
- During pregnancy and lactation patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase II Study of Pemetrexed Versus Gefitinib in Previously Treated Patients With Advanced Non-small Cell Lung Cancer
To compare the efficacy of gefitinib versus pemetrexed as second-line chemotherapy for patients with previous treated non-small cell lung cancer
- Being tested
- Gefitinib, Pemetrexed
- Keywords
- Pemetrexed, Gefitinib, iressa, alimta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GefitinibDrug
Also called irressa
compare progression free survivla rate and safety to both drugs
PemetrexedDrug
Also called alimta
compare PFS rate, safety to both drugs
| Study group | Role | What they receive |
|---|---|---|
| pemetrexed | Active comparator | pemetrexed Receives: Drug: Pemetrexed |
| gefitinib | Active comparator | gefitinib Receives: Drug: Gefitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: 5 years
Secondary outcomes (1)
Progression free survival
Measured: 5years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startFeb 2008
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Previous Treated Metastatic 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Kyung Cho, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783834
- Sponsor's protocol ID
- 2008-GIRBA-1739
- Status last verified
- Feb 2016
- First submitted
- 30 Jan 2013
- Last updated
- 11 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of Pemetrexed Versus Gefitinib in Previously Treated Patients With Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01783834
- Acronym / sponsor ID
- 2008-GIRBA-1739
- Keywords
- Pemetrexed, Gefitinib, iressa, alimta
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 5 Feb 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.
To compare the efficacy of gefitinib versus pemetrexed as second-line chemotherapy for patients with previous treated non-small cell lung cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pemetrexed | Active comparator | Drug: Pemetrexedpemetrexed |
| gefitinib | Active comparator | Drug: Gefitinibgefitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cells pathologically diagnosed as histological or radical surgery or radiation therapy is not possible stage IIIB and stage IV non-small-cell lung cancer patients
- second line
- ECOG 0～2
- Patients with normal liver function and renal function
Key exclusion criteria (3 listed)
- Patients with severe acute infection requiring antibiotic therapy
- Patients who have received treatment in other areas of cancer within 5 years
- During pregnancy and lactation patients
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 |
|---|---|---|
| GefitinibAlso: irressacompare progression free survivla rate and safety to both drugs | Drug | gefitinib |
| PemetrexedAlso: alimtacompare PFS rate, safety to both drugs | Drug | pemetrexed |
Primary outcome
Overall response rate
Time frame: 5 years
1 secondary outcome
Progression free survival
Time frame: 5years
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 11 Feb 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Gefitinib and Pemetrexed in people with Previous Treated Metastatic Non-small Cell Lung Cancer, run by Gachon University Gil Medical Center at 1 site in South Korea.
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 3 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 11 Feb 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 South Korea. 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 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?
Overall response rate (time frame: 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 11 Feb 2016.