Non-squamous non-small cell lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: First step(induction) 1)Histologically or cytologically proven non-squamous non-small cell lung cancer 2)Wild type EGFR 3)Stage IIIB,stageIV without any indications for radiotherapy 4)No prior chemotherapy 5)ECOG performance status 0-1 6)With one or more measurable disease (RECIST ver.1.1) 7) Aged 20<=, <=74 8)Adequate organ function 9)In case of non-chest radiation, need more than two weeks interval after last radiation 10)Written informed concent Second step (maintenance) 1)Non-PD patients after induction therapy 2)Adequate organ function after non-PD confirmation 3)ECOG performance status 0-1
Exclusion criteria
Exclusion criteria: First step(induction) 1)Symptomatic brain metastasis 2)Current history of hemoptysis 3)With pulmonary cavity lesions 4)History of radical thoracic radiotherapy 5)Active infections diseases 6)Fever over 38 degrees centigrade 7)Serious complications 8)Massive pleural and cardiac effusion and ascites that need to be immediately treated 9)Active concomitant cancers 10)Severe drug allergy 11)Uncontrollable ulcer indigestive tract 12)Perforation of the digestive tract or history within the past one year 13)Receiving anticoagulant drug (325mg and less aspirin is possible) 14) Pregnancy, breastfeeding or suspected of being pregnant 15)Those judged to be not suitable by the attending physician Second step (maintenance) 1)Symptomatic brain metastasis 2)Accompanied by serious complication in induction therapy 3) Severe drug allergy for PEM or BEM or severe adverse effect in induction therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Examination of the immunity in patients entered TORG1321 study (UMIN000010681). | — |
Secondary
| Measure | Time frame |
|---|---|
| The comparison of the immunity between patients with or without treatment of bevacizumab. | — |
Countries
Japan
Contacts
Tochigi Cancer Center Department of Medical Oncology, Division of Thoracic Oncology