Multicenter phase II trial of continuous EGFR-TKIs for elderly patients with EGFR sensitive mutation who failed the first EGFR-TKIs treatment for advanced non-small cell lung cancer. - Multicenter phase II trial of continuous EGFR-TKIs for elderly patients with EGFR sensitive mutation who failed the first EGFR-TKIs treatment for advanced non-small cell lung cancer.

ung Oncology Group in Kyushu, Japan (LOGIK)0 个研究点目标入组 70 人开始时间: 2012年5月28日最近更新: 2023年10月17日

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•1. Patients with difficulty of oral dosing continuation for 250mg gefitinib more than once in three days, more than 50 mg erlotinib every day or more than 100mg erlotinib every other day, or more than 20 mg afatinib every day. 2. Patients with active infection or uncontrollable disease. 3. Patients with clinically pulmonary disorders such as idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia or radioactive pneumonitis on chest CT. 4. Patients with induction or adjuvant chemotherapy within 12 months. 5. Patients with massive pleural effusion, ascites, pericardial effusion or SVC syndrome (drainage or pleurodesis with OK432 or bleomycin are permissive.) 6. Patients with symptomatic brain metastases or with treatment needs for steroids, anticonvulsant, etc. 7. Patients with severe drug allergy. 8. Patients with grade 3 or more diarrhea. 9. History of radiation therapy for mediastinum or lung. 10. History of active double cancer within 2 years. 11. Patients with hypersensitivity history or its suspicion to gefitinib, erlotinib and afatinib. 12. HBs antigen positive. 13. Patients who have possibility of pregnancy. 14. Patients whose participation in the trial is judged to be inappropriate by the attending doctor.

发起方

ung Oncology Group in Kyushu, Japan (LOGIK)