advanced non-squamous non-small cell lung cancer harboring EGFR mutaiton
Conditions
Interventions
A: Gefitinib (ar a dose of 250 mg per day orally)
B: 1) Gefitinib (250 mg per day orally) was administrated on days 1-56. 2) Two-week drug free period. 3) Cisplatin (80 mg per suquare meter
Sponsors
Japan Clinical Oncology Group (JCOG)
West Japan Oncology Group (WJOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Cytologically or histologically confirmed non-squamous non-small cell lung cancer [adenocarcinoma, large cell carcinoma (except for large cell neuroendocrine carcinoma), or non-small cell lung cancer not otherwise specified]. 2) Clinical stage IIIB without indication of definitive thoracic radiotherapy, stage IV, or postoperative recurrent disease. 3) Presence of EGFR activating mutation (exon 19 deletion or exon 21 L858R point mutation) and absence of EGFR exon 20 T790M point mutation. Absence of KRAS mutation (if checked). 4) Age of 20 to 74 years. 5) ECOG performance status 0-1. 6) Measureable or non-measureable. 7) No symptomatic brain metastasis, leptomeningeal metastasis, or spinal cord metastasis requiring radiotherapy or surgical operation. 8) No superior vena cava syndrome, pericardial effusion, pleural effusion, or ascites of grade 3 or more. 9) No history of surgical operation accompanied with organ resection within 28 days before registraion. 10) No prior radiotherapy to the metastasis of lung cancer within 14 days before registraion. 11) No prior systemic chemotherapy or definitive thoracic radiotherapy. 12) Adequate organ funcion 13) No findings suggestive of interstitial lung disease or pulmonary fibrosis on the chest computed tomography. 14) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Synchronous double or multiple cancer or metachronous double or multiple cancer with progression free period less than 5 years. 2) Infectious disease requiring systemic treatment. 3) Pyrexia of 38 degrees centigrade or higher. 4) During pregnancy, within 28 days of postparturition, or during lactation. 5) Psychological disorder difficult to participate in this clinical study. 6) Receiving continuous systemic corticosteroid or immunosuppressant treatment. 7) Diabetes mellitus uncontrollable with the appropriate treatment. 8) Uncontrollable hypertension. 9) History of unstable angina pectoris or myocardial infarction within 6 months before registration. 10) Positive for serum hepatitis B surface antigen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, response rate, adverse events, severe adverse events, proportion of EGFR T790M mutation positive in biopsy tisuues at disease progression | — |
Countries
Japan
Contacts
Public ContactShintaro Kanda
JCOG1404 Coordinating Office Department of Thoracic Oncology, National Cancer Center Hospital
Outcome results
None listed