Patients with completely resected pathological stage II or III non-small cell lung cancer with mutated EGFR
Conditions
Interventions
gefitinib
cisplatin and vinorelbine combination therapy
Sponsors
Clinical trial coordinating committee for WJOG 6410L investigator-initiated multicenter clinical trial
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients for whom non-small cell lung cancer is confirmed histologically 2) Patients underwent at least lung lobectomy including elective or non-elective dissection of hilar or mediastinal lymph node 3) Complete resection is judged (Complete resection is defined to be the situation that tumor is completely removed grossly at the time of operation and tumor cells are not noted pathologically on the resection line.) 4) The pathological stage is IIA, IIB, IIIA or IIIB. 5) For primary tumor, there is either of deletion of exon19 or exon21 L858R in EGFR gene mutation AND there is no T790M gene mutation. (The commercial test method now in Japan should be used.) 6) At the time of enrollment, patients should be at least 20 years old and younger than 75 years old. 7) PS (ECOG; Eastern Cooperative Oncology Group) is 0-1. 8) Trial treatment can be started within 6 to 10 weeks after resection. 9) Functions of the bone marrow, liver, kidney, and lung etc are maintained, satisfying the following conditions. (The following data should be the ones within 2 weeks before enrollment. The same day of the week 2 weeks before enrollment can be included.) *Hemoglobin concentration>=10 g/dL *Neutrophil count >=2,000/mm3 *Platelet count >=100,000/mm3 *AST/ALT <=2.0 X ULN of normal values in each institution *Total bilirubin <=1.5 mg/dL *Serum creatinine <=1.2 mg/dL *Dermal toxicity <=Grade 2 *SpO2 >=95% 10) After the details of the trial are explained sufficiently before enrollment in this trial, written consent by patients themselves should be obtained.
Exclusion criteria
Exclusion criteria: 1) Patients with interstitial pneumonia or pulmonary fibrosis on chest plain CT 2) Patients with a history of acute lung injury, sporadic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, or drug-induced pneumonia 3) Patients with active double cancer 4) Pregnant or breast-feeding females and females who have a possibility of pregnancy or lactation or patients who does not intend to use birth control 5) Patients with poor-controlled diabetes mellitus 6) Patients with active serious infections (such as the patients showing fever at >=38.0 degrees Celsius) 7) Patients with other serious concomitant diseases (gastrointestinal bleeding, cardiovascular disease) or focus of infection in the thoracic cavity 8) Patients with serious hypersensitivity to drugs 9) Patients undergoing treatment with an anticancer agent or radiotherapy in the last 5 years,except for Carcinoma in situ or intramucosal carcinoma with radiation therapy. (intrathoracic administration of PICIBANIL is not regarded as administration of an anticancer agent) 10) Patients judged to be difficult to be enrolled in this trial because of clinically problematic psychiatric disorders 11) Patients administered the other investigational product within 12 weeks before random allocation 12) Other patients judged to be ineligible for safe implementation of this trial by the investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival Safety and tolerability Type of recurrence | — |
Countries
Japan
Contacts
Public ContactHiroshi Miyamoto
Secretariat of Clinical trial coordinating committee for WJOG 6410L investigator-initiated multicent (non)
Outcome results
None listed