EGFR positive non-sqamous non-small cell lung cancer
Conditions
Interventions
1st line: gefitinib, 2nd line: gefitinib + CDDP or CBDCA + pemetrexed, 3rd line: gefitinib + docetaxel , 4th to 6th line: gefitinib + paclitaxel, gemcitabine, or TS-1
1st line: gefitinib, 2nd line: C
Sponsors
Thoracic Oncology Research Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed non-squamous, non-small cell lung cancer with active EGFR mutations 2)-1. Stage III/ IV patients with postoperative recurrence or non-curative status by radiotherapy 2)-2. Acquired resistance for 1st line gefitinib treatment 3) No prior chemotherapy 4) ECOG performance status 0-1 5) Aged 20 to 74 years old. 6) Adequate organ function 7) Estimated life expectancy at least 3 months 8) at least one measurable lesion 9) Written informed consent by patient
Exclusion criteria
Exclusion criteria: 1) Treated by other molecular targeted drug or cytotoxic agent 2) Prior radiation for primary lesions 3) History of steroid therapy for radiation pneumonitis 4) Patients with symptomatic brain metastasis 5) Interstitial pneumonitis or pulmonary fibrosis detectable on CT scan 6) Patient with pleural effusion, pericardial effusion, ascites or superior vena cave 7) With active infection or other serious medical complications 8) Clinically significant allergy 9) With active double cancer 10) Pregnancy or lactating patients 11) Judged to be not suitable by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 years survival rate after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of the flare, overall survival, safety, QOL, response rates of 2nd and 3rd line therapies , and progression-free survivals of 2nd and 3rd line therapies | — |
Countries
Japan
Contacts
Public ContactNobuhiko Seki
Teikyo university school of medicine Division of Medical oncology
Outcome results
None listed