Squamous Cell Carcinoma of BronchusPhase 2SIISNCT01485809
Efficacy and Safety Study of Gefitinib in Squamous NSCLC Patients Who Failed First-Line Chemotherapy
A Phase 2 study testing Gefitinib in people with Squamous Cell Carcinoma of Bronchus, run by Seoul Veterans Hospital at 1 site in South Korea.
Trial summary
Gefitinib was the first epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) approved for the treatment of advanced non-small cell lung cancer (NSCLC). Results from two randomised phase II trials (IDEAL 1 and 2) suggested that gefitinib was efficacious and less toxic, compared with previous results… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Bronchus
- What is being tested?
- Gefitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2011to Nov 2016
- 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
- Histologically or cytologically confirmed locally advanced(stage IIIB or IV) squamous NSCLC
- Failure of only one first line chemotherapy for advanced disease
- At least one lesion that unidimensionally measurable by computed tomography (RECIST 1.1)
- Performance status: ECOG 0-2
- Age ≥20
- Adequate renal function: serum creatinine level < 2 mg/dL (177 μmol/L)
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- Adequate liver functions
- : Transaminase (AST/ALT) < 2 X upper normal value
- Bilirubin < 2 X upper normal value
- Adequate hematological function: hemoglobin ≥ 9 g/dL absolute neutrophil count (ANC) ≥ 1,500/μL and platelet count ≥ 100,000/μL
- Life expectancy 3 months
- Written Informed consent prior to any study specific procedures
- NSCLC with an activating sensitizing EGFR mutation
Who cannot join
- Two or more chemotherapy treatment regimen for advanced disease
- Previous therapy with other EGFR-TKI related drug
- Known or suspected brain metastases or spinal cord compression
- Radiotherapy within 4 weeks before study entry
- Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
- Pregnant or lactating women
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- Other serious illness or medical conditions as judged by the investigator
- Known severe hypersensitivity to gefitinib or any of the excipients of the product
- Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.
- Presence of EGFR mutation reported to confer resistance to EGFR TKI: exon 20 point mutation (T790M or S768I EGFR) or exon 20 insertion
- Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy.
- Concomitant use of known CYP 3A4 inducers such as phenytoin, carbamazepine, rifampicin, barbiturates,
- Involvement in the planning and/or conduct of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Trial of Gefitinib in Squamous NSCLC Patients Who Failed First-Line Chemotherapy
Gefitinib was the first epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) approved for the treatment of advanced non-small cell lung cancer (NSCLC). Results from two randomised phase II trials (IDEAL 1 and 2) suggested that gefitinib was efficacious and less toxic, compared with previous results, than was chemotherapy in patients with previously-treated non-small-cell lung cancer. Two phase III trials of gefitinib in advanced non-small-cell lung cancer followed on from the IDEAL phase II studies: Iressa Survival Evaluation in Lung cancer (ISEL) and Iressa NSCLC Trial Evaluating REsponse and Survival versus Taxotere (INTEREST). Although the phase III ISEL trial failed to prove the superiority of gefitinib treatment compared to placebo in previously treated patients, a subgroup analysis demonstrated improved survival in particular populations (Asians and non-smokers). The INTEREST study compared an EGFR tyrosine kinase inhibitor with chemotherapy in pretreated advanced non-small-cell lung cancer. In INTEREST, survival was similar for gefitinib and docetaxel in almost all subgroups; no EGFR-related biomarker or any clinical factor (including female sex, adenocarcinoma histology, never-smoker, and Asian ethnicity) appeared to be predictive of a greater survival benefit for gefitinib versus docetaxel. However, these factors may still be predictive of a greater survival benefit for gefitinib and/or docetaxel versus best supportive care; alternatively, they may just be good prognostic factors. Progression free survival and overall response rate was no statistically significant difference between gefitinib and docetaxel. This suggests gefitinib can provide similar overall survival to docetaxel in pretreated advanced non-small-cell lung cancer patients. These studies have demonstrated that gefitinib is effective for the second-line treatment of NSCLC. Now, gefitinib is recommended in advanced and metastatic NSCLC as second-line chemotherapy.
But, there was no prospective study with gefitinib in NSCLC wih squamous cell histology. This trial will investigate the efficacy and safety of gefitinib in locally advanced, metastatic NSCLC patients with squamous cell histology who have failed first-line chemotherapy.
- Conditions
- Squamous Cell Carcinoma of Bronchus
- Being tested
- Gefitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GefitinibDrug
Also called Iressa
Gefitinib 250mg/day, oral daily q every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Gefitinib | Experimental | Not described Receives: Drug: Gefitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate (complete response, partial response, or stable disease) at 8 weeks
Measured: 8 weeks
Secondary outcomes (1)
number of participants with adverse events as a measure of safety and tolerability
safety \& tolerability: NCI CTCAE version 4.0
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2011
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of BronchusStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul Veterans Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bong-Seog Kim, Seoul Veterans Hospital
- Investigators
- Bong-Seog Kim, M.D, Principal investigator, Seoul Veterans Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485809
- Sponsor's protocol ID
- SVH-1
- Acronym
- SIIS
- Status last verified
- Nov 2023
- First submitted
- 24 Nov 2011
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Gefitinib in Squamous NSCLC Patients Who Failed First-Line Chemotherapy
- ClinicalTrials.gov ID
- NCT01485809
- Acronym / sponsor ID
- SIIS / SVH-1
- Conditions
- Squamous Cell Carcinoma of Bronchus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Seoul Veterans HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 6 Dec 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.
Gefitinib was the first epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) approved for the treatment of advanced non-small cell lung cancer (NSCLC). Results from two randomised phase II trials (IDEAL 1 and 2) suggested that gefitinib was efficacious and less toxic, compared with previous results, than was chemotherapy in patients with previously-treated non-small-cell lung cancer. Two phase III trials of gefitinib in advanced non-small-cell lung cancer followed on from the IDEAL phase II studies: Iressa Survival Evaluation in Lung cancer (ISEL) and Iressa NSCLC Trial Evaluating REsponse and Survival versus Taxotere (INTEREST). Although the phase III ISEL trial failed to prove the superiority of gefitinib treatment compared to placebo in previously treated patients, a subgroup analysis demonstrated improved survival in particular populations (Asians and non-smokers). The INTEREST study compared an EGFR tyrosine kinase inhibitor with chemotherapy in pretreated advanced non-small-cell lung cancer. In INTEREST, survival was similar for gefitinib and docetaxel in almost all subgroups; no EGFR-related biomarker or any clinical factor (including female sex, adenocarcinoma histology, never-smoker, and Asian ethnicity) appeared to be predictive of a greater survival benefit for gefitinib versus docetaxel. However, these factors may still be predictive of a greater survival benefit for gefitinib and/or docetaxel versus best supportive care; alternatively, they may just be good prognostic factors. Progression free survival and overall response rate was no statistically significant difference between gefitinib and docetaxel. This suggests gefitinib can provide similar overall survival to docetaxel in pretreated advanced non-small-cell lung cancer patients. These studies have demonstrated that gefitinib is effective for the second-line treatment of NSCLC. Now, gefitinib is recommended in advanced and metastatic NSCLC as second-line chemotherapy.
But, there was no prospective study with gefitinib in NSCLC wih squamous cell histology. This trial will investigate the efficacy and safety of gefitinib in locally advanced, metastatic NSCLC patients with squamous cell histology who have failed first-line chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gefitinib | Experimental | Drug: Gefitinib |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically or cytologically confirmed locally advanced(stage IIIB or IV) squamous NSCLC
- Failure of only one first line chemotherapy for advanced disease
- At least one lesion that unidimensionally measurable by computed tomography (RECIST 1.1)
- Performance status: ECOG 0-2
- Age ≥20
Key exclusion criteria (13 listed)
- Two or more chemotherapy treatment regimen for advanced disease
- Previous therapy with other EGFR-TKI related drug
- Known or suspected brain metastases or spinal cord compression
- Radiotherapy within 4 weeks before study entry
- Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
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: IressaGefitinib 250mg/day, oral daily q every 4 weeks | Drug | Gefitinib |
Primary outcome
Disease control rate (complete response, partial response, or stable disease) at 8 weeks
Time frame: 8 weeks
1 secondary outcome
number of participants with adverse events as a measure of safety and tolerability
Time frame: 2 years
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 24 Nov 2023.
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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.
Bong-Seog Kim, M.D principal investigator
Seoul Veterans 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 Gefitinib in people with Squamous Cell Carcinoma of Bronchus, run by Seoul Veterans Hospital 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 13 inclusion and 13 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 24 Nov 2023. 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?
Disease control rate (complete response, partial response, or stable disease) at 8 weeks (time frame: 8 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 24 Nov 2023.