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

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.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of Bronchus Drug: Gefitinib Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Gefitinib in Squamous NSCLC Patients Who Failed First-Line Chemotherapy
Study Start Date : October 2011
Primary Completion Date : October 2011
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Gefitinib Drug: Gefitinib
Gefitinib 250mg/day, oral daily q every 4 weeks
Other Name: Iressa

Primary Outcome Measures :
  1. Disease control rate (complete response, partial response, or stable disease) at 8 weeks [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 2 years ]
    safety & tolerability: NCI CTCAE version 4.0

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01485809

Contact: Taekyu Lim, M.D +82-2-2225-1599

Korea, Republic of
Seoul Veterans Hospital Recruiting
Seoul, Korea, Republic of, 134-791
Contact: Taekyu Lim, M.D    +82-2-2225-1599      
Sponsors and Collaborators
Seoul Veterans Hospital
Principal Investigator: Bong-Seog Kim, M.D Seoul Veterans Hospital

Responsible Party: Bong-Seog Kim, Principal investigator, Seoul Veterans Hospital Identifier: NCT01485809     History of Changes
Other Study ID Numbers: SVH-1
First Posted: December 6, 2011    Key Record Dates
Last Update Posted: December 6, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Carcinoma, Bronchogenic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action