Status:
COMPLETED
Efficacy and Safety Study of Gefitinib in Squamous NSCLC Patients Who Failed First-Line Chemotherapy
Lead Sponsor:
Seoul Veterans Hospital
Conditions:
Squamous Cell Carcinoma of Bronchus
Eligibility:
All Genders
20+ years
Phase:
PHASE2
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 pha...
Eligibility Criteria
Inclusion
- 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)
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01485809
Start Date
October 1 2011
End Date
November 1 2016
Last Update
November 24 2023
Active Locations (1)
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1
Seoul Veterans Hospital
Seoul, South Korea, 134-791