non-squamous non-small cell lung cancer
Conditions
Interventions
Pemetrexed at a dose of 500 mg/m2 every 3 weeks is administered until progression disease.
Sponsors
Hanshin Cancer Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically proven non-squamous non-small cell lung cancer (except large cell neuroendocrine carcinoma) 2)Non-squamous non-small cell cancer patients with stage IIIB(with pleural dissemination or malignant pleural effusion),stage IV or recurrent disease after surgery,who have 1 or 2 prior chemoterapy 3)With measurable or inmeasurable lesion 4)If the patient underwent radiotherapy, there should be the following interval between the radiotherapy and the registration i)Radiotherapy including pulmonary field ->3 months ii)Radiotherapy other than thoracic radiation ->1 weeks 5)over 20 years old 6)ECOG PS 2 7)History of 1 or 2 prior chemotherapy (EGFR-TKIs and UFT can be uncountable) 8)In patients with sensitive EGFR mutations, they become eligible after failure of EGFR-TKIs. 9)Adequate organ function 10)Life expectancy more than 3 months 11)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Interstitial pneumonia or pulmonary fibrosis detectable on CT scan 2)History of drug induced interstitial pneumonia 3)History of severe drug allergy 4)History of active infection or other serious disease condition (GI bleeding,etc.) 5)History of poorly controlled pleural effusion,pericardial effusion and ascites 6)History of severe heart disease(uncontrollable arrythmia, uncontrollable angina pectoris, herat failure, etc.) 7)Uncontrollable diabetes mellitus 8)History of symptomatic brain metastases 9)Hystory of active double cancer 10)History of active psychological disease 11)Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate Progression-free survival Disease control rate Safety | — |
Countries
Japan
Contacts
Public ContactAkito Hata
Institute of Biomedical Research and Innovation Division of Integrated Oncology
Outcome results
None listed