non-squamous non-small cell lung cancer
Conditions
Interventions
Randomization phase II study of the maintenance therapy with chemotherapy non-enforcement IIIB/IV period, pemetrexed following induction therapy with pemetrexed / cisplatin for patients with postopera
Sponsors
International University of Health and Welfare Respiratory Disease Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Histologically or cytologically confirmed non-squamuous, non-small cell lung cancer and stage IV or recurrent non-small cell lung cancer 2 A stage IIIB the clinic that radical irradiation is impossible of or stage IV and postoperative recurrence symptom example. 3 With the EGFR active form mutation in the gene more than G719X, 19del, L858R, one one of L861Q. 4 The case that recurred after the above after last administration for half a year of chemotherapy non-enforcement or the postoperative adjuvant chemotherapy. We exclude the case given Gefitinib or pemetrexed as postoperative adjuvant chemotherapy. Also, we do not include the picibanil which we used in pleurodesis and the minocycline in chemotherapy. 5 The age of the agreement acquisition day is a case younger than 75 years 20 years old or older. 6 ECOG Performance Status 0-1 7 With one or more measurable lesions based on RECIST version 1.1 8 Adequate organ function 9 The case that the survival that is more three months or more than the treatment starting date can expect. 10 An orally-available case. 11 The case that an agreement by the free will of the patients is obtained in a document about participation of this study.
Exclusion criteria
Exclusion criteria: 1) The case that a squamous cancer ingredient accounts for more than 50% in the case of mixed type with the squamous cancer. 2) A mixed case with small cell lung cancer. 3) We have EGFR resistance gene mutation (T790M). 4) With the symptom or metastases to brain case to need treatment such as a steroid or the antispasmodic. 5) The case with a history of the hemoptysis or the merger. 6) The case with a history, the merger of the following sputum bloody.d 7) A case that was given the radiotherapy for the chest. 8) It is a case of after the palliative irradiation for bone metastases or the metastases to brain except the primary tumor for less than two weeks. 9) The invasion of the primary tumor is found in in great vessels in trachea or lobar bronchus or the TNM classification T4 of the lung cancer handling agreement revision seventh edition partly. 10) A case with the superior vena caval syndrome. 11) A case with the interstitial pneumonia that is clear by chest CT or pulmonary fibrosis. 12) The case with a serious infection. 13) The case with serious complications. 14) The case with pleural effusion, ascitic fluid requiring treatment such as the drainage and the pericardial fluid. 15)A case with the multiple primary cancer of the activity. 16)A case with a history of serious drug allergy. 17)Uncontrollable hypertension < 160/100 18) A case with a history of less than one year before merger of cerebrovascular disorder with the symptom or registration. 19) Need to antiplatelet therapy or anticoagulation therapy without Aspirin 325 mg/day 20) Gastrointestinal perforation within 1 year 21) The case that it was judged mental disorder to become the clinical problem to have difficulty in registration to this study. 22) With pregnancy and the pregnant likelihood or women nursing or men in hope of fertility. 23)Inappropriate for this study judged by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year progression free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| RR response rate DCP disease Control proportion OS overall survival PFS progression free survival AEs Adverse Events | — |
Countries
Japan
Contacts
Public ContactSeisuke Nagase
International University of Health and Welfare Respiratory Disease Center
Outcome results
None listed