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Efficacy and Safety Study of Gefitinib in Squamous NSCLC Patients Who Failed First-Line Chemotherapy (SIIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01485809
Recruitment Status : Unknown
Verified December 2011 by Bong-Seog Kim, Seoul Veterans Hospital.
Recruitment status was:  Recruiting
First Posted : December 6, 2011
Last Update Posted : December 6, 2011
Information provided by (Responsible Party):
Bong-Seog Kim, Seoul Veterans Hospital

Tracking Information
First Submitted Date  ICMJE November 24, 2011
First Posted Date  ICMJE December 6, 2011
Last Update Posted Date December 6, 2011
Study Start Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2011)
Disease control rate (complete response, partial response, or stable disease) at 8 weeks [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2011)
number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 2 years ]
safety & tolerability: NCI CTCAE version 4.0
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of Gefitinib in Squamous NSCLC Patients Who Failed First-Line Chemotherapy
Official Title  ICMJE A Phase II Trial of Gefitinib in Squamous NSCLC Patients Who Failed First-Line Chemotherapy
Brief 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, 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Squamous Cell Carcinoma of Bronchus
Intervention  ICMJE Drug: Gefitinib
Gefitinib 250mg/day, oral daily q every 4 weeks
Other Name: Iressa
Study Arms  ICMJE Experimental: Gefitinib
Intervention: Drug: Gefitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 5, 2011)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2014
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histologically or cytologically confirmed locally advanced(stage IIIB or IV) squamous NSCLC
  2. Failure of only one first line chemotherapy for advanced disease
  3. At least one lesion that unidimensionally measurable by computed tomography (RECIST 1.1)
  4. Performance status: ECOG 0-2
  5. Age ≥20
  6. Adequate renal function: serum creatinine level < 2 mg/dL (177 μmol/L)
  7. Adequate liver functions

    • : Transaminase (AST/ALT) < 2 X upper normal value
    • Bilirubin < 2 X upper normal value
  8. Adequate hematological function: hemoglobin ≥ 9 g/dL absolute neutrophil count (ANC) ≥ 1,500/μL and platelet count ≥ 100,000/μL
  9. Life expectancy 3 months
  10. Written Informed consent prior to any study specific procedures
  11. NSCLC with an activating sensitizing EGFR mutation

Exclusion Criteria:

  1. Two or more chemotherapy treatment regimen for advanced disease
  2. Previous therapy with other EGFR-TKI related drug
  3. Known or suspected brain metastases or spinal cord compression
  4. Radiotherapy within 4 weeks before study entry
  5. Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
  6. Pregnant or lactating women
  7. Other serious illness or medical conditions as judged by the investigator
  8. Known severe hypersensitivity to gefitinib or any of the excipients of the product
  9. Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.
  10. Presence of EGFR mutation reported to confer resistance to EGFR TKI: exon 20 point mutation (T790M or S768I EGFR) or exon 20 insertion
  11. Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy.
  12. Concomitant use of known CYP 3A4 inducers such as phenytoin, carbamazepine, rifampicin, barbiturates,
  13. Involvement in the planning and/or conduct of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01485809
Other Study ID Numbers  ICMJE SVH-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bong-Seog Kim, Seoul Veterans Hospital
Study Sponsor  ICMJE Seoul Veterans Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bong-Seog Kim, M.D Seoul Veterans Hospital
PRS Account Seoul Veterans Hospital
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP