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A Phase II Trial of Gefitinib in Squamous NSCLC Patients Who Failed First-Line Chemotherapy

Phase 2
20 Years
Open (Enrolling)
Squamous Cell Carcinoma of Bronchus

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Trial Information

A Phase II Trial of Gefitinib in Squamous NSCLC Patients Who Failed First-Line Chemotherapy

Inclusion Criteria:

1. Histologically or cytologically confirmed locally advanced(stage IIIB or IV) squamous

2. Failure of only one first line chemotherapy for advanced disease

3. At least one lesion that unidimensionally measurable by computed tomography (RECIST

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

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease control rate (complete response, partial response, or stable disease) at 8 weeks

Outcome Time Frame:

8 weeks

Safety Issue:


Principal Investigator

Bong-Seog Kim, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul Veterans Hospital


Korea: Institutional Review Board

Study ID:




Start Date:

October 2011

Completion Date:

February 2014

Related Keywords:

  • Squamous Cell Carcinoma of Bronchus
  • Carcinoma
  • Carcinoma, Bronchogenic
  • Carcinoma, Squamous Cell