Phase II of Gefitinib (IRESSA) Administered as First-line Treatment in Patients With Non-resectable Pneumonic-type Adenocarcinoma (P-ADC)

IFCT-0401

Pneumonic adenocarcinoma (P-ADC) is defined as a primary lung ADC with a radiological pneumonic presentation, usually referred to histologically as ADC with a mixed-invasive and BAC predominant subtype in the 2004 WHO classification. Surgery is the best therapy for resectable tumors since the effectiveness of chemotherapy is disappointing. In the advanced P-ADC diffuse/multifocal types of BAC, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) (gefitinib and erlotinib) have shown promise, with some rapid, dramatic responses, possibly reflecting specific molecular differences from other non-small cell lung carcinomas.

2005-04-01

2008-12-01

2009-12-01

Completed

Early phase I

90

Inclusion Criteria: * Pathologically / cytologically proven ADC-P * Non-resectable disease * 3-month expected survival * No prior radiotherapy or chemotherapy * Age \>= 18 years old * Performance status \< 4 (WHO) * Adequate blood biological parameters Exclusion Criteria: * Abnormal initial fibroscopy

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 90, 'type': 'ACTUAL'}}

2024-03-08