Nonsmall Cell Lung CancerPhase 2NCT01312337
Iressa for EGFR Mutation Negative Non-small Cell Lung Cancer (NSCLC)
A Phase 2 study testing salvage iressa in people with Nonsmall Cell Lung Cancer, run by Samsung Medical Center at 2 sites in South Korea.
Trial summary
The investigators will examine efficacy and toxicity of gefitinib in Korean patients with EGFR wild tumors diagnosed with direct sequence test. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonsmall Cell Lung Cancer
- What is being tested?
- salvage iressa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Sep 2010to Aug 2012
- 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
- Pathologically proven NSCLC
- Ineligibile for curative treatment (namely, stage IIIb or IV)
- History of one to three prior systemic chemotherapy tumors without active EGFR mutations (exon 19 deletion, L858R mutation in exon 21)
- At least one lesion that was unidimensionally measurable by computed tomography (by RECIST 1.1)
- 18 years old or older
- Performance status ECOG 0-2
Show all 12Show fewer
- Adequate organ function as evidenced by the following:
- Absolute neutrophil count > 1.0 x 109/L
- Platelets > 75 x 109/L
- Total bilirubin ≤ 1.5 UNL
- AST and/or ALT < 5 UNL
- Creatinine clearance ≥ 45mL/min
Who cannot join
- Previous EGFR TKI therapy history
- Systemic anticancer therapy within the previous 3 weeks
- Other invasive malignancy within the past 2 years except non-melanoma skin cancer, in situ cervix cancer, or papillary thyroid cancer
- Other concurrent illness that would preclude study participation (severe heart disease)
- Other concurrent physical condition (e.g., infectious disease) that would preclude study participation
- Pregnant or nursing
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Not yet recruiting
Samsung Medical Center
Seoul, 135-710
Myung-Ju Ahn, Pf, 822-3410-3459
- Recruiting
Samsung Medical Center
Seoul, 135-710
Myung-Ju ahn, Pf, 82-2-3410-3459, silkahn@skku.edu
About this study
Official title: A Phase II Trial of Gefitinib Monotherapy in Pretreated Patients With Advanced Non-small Cell Lung Cancer Not Harboring Active EGFR Mutations
The investigators will examine efficacy and toxicity of gefitinib in Korean patients with EGFR wild tumors diagnosed with direct sequence test.
- Conditions
- Nonsmall Cell Lung Cancer
- Being tested
- salvage iressa
- Keywords
- gefitinib, EGFR mutation negative, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salvage iressaDrug
Iressa 250mg per day until progression
| Study group | Role | What they receive |
|---|---|---|
| Iressa for EGFR wild group | Experimental | salvage Iressa therapy for patients with EGFR mutation negative NSCLC patients Receives: Drug: salvage iressa |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine disease control rate at 8 weeks will be 35% or higher in the the study group
Measured: 6 months after the enrollment of the last patients
Secondary outcomes (1)
The number of patients who live longer than 6 months after enrollment
Measured: 6 months after the enrollment of the last patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startSep 2010
- Primary completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonsmall Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312337
- Sponsor's protocol ID
- 2010-07-252
- Status last verified
- Mar 2011
- First submitted
- 21 Feb 2011
- Last updated
- 10 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Gefitinib Monotherapy in Pretreated Patients With Advanced Non-small Cell Lung Cancer Not Harboring Active EGFR Mutations
- ClinicalTrials.gov ID
- NCT01312337
- Acronym / sponsor ID
- 2010-07-252
- Conditions
- Nonsmall Cell Lung Cancer
- Keywords
- gefitinib, EGFR mutation negative, NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Aug 2012 (estimated)
- First posted
- 10 Mar 2011 (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.
The investigators will examine efficacy and toxicity of gefitinib in Korean patients with EGFR wild tumors diagnosed with direct sequence test.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iressa for EGFR wild group | Experimental | Drug: salvage iressasalvage Iressa therapy for patients with EGFR mutation negative NSCLC patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Pathologically proven NSCLC
- Ineligibile for curative treatment (namely, stage IIIb or IV)
- History of one to three prior systemic chemotherapy tumors without active EGFR mutations (exon 19 deletion, L858R mutation in exon 21)
- At least one lesion that was unidimensionally measurable by computed tomography (by RECIST 1.1)
- 18 years old or older
Key exclusion criteria (6 listed)
- Previous EGFR TKI therapy history
- Systemic anticancer therapy within the previous 3 weeks
- Other invasive malignancy within the past 2 years except non-melanoma skin cancer, in situ cervix cancer, or papillary thyroid cancer
- Other concurrent illness that would preclude study participation (severe heart disease)
- Other concurrent physical condition (e.g., infectious disease) that would preclude study participation
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 |
|---|---|---|
| salvage iressaIressa 250mg per day until progression | Drug | Iressa for EGFR wild group |
Primary outcome
To determine disease control rate at 8 weeks will be 35% or higher in the the study group
Time frame: 6 months after the enrollment of the last patients
1 secondary outcome
The number of patients who live longer than 6 months after enrollment
Time frame: 6 months after the enrollment of the last patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2011.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing salvage iressa in people with Nonsmall Cell Lung Cancer, run by Samsung Medical Center at 2 sites 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 12 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Myung-Ju Ahn, Pf (82-2-3410-3459, silkahn@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine disease control rate at 8 weeks will be 35% or higher in the the study group (time frame: 6 months after the enrollment of the last patients). 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 2011.