Non-Squamous Non-Small-Cell Lung Cancer
Conditions
Interventions
Docetaxel(60mg/m2)day1 +Bevacizumab (15mg/kg) day 1 The treatment is repeated every three weeks until disease progression.
S-1 80mg-120mg/m2day1-day14 Bevacizumab 15mg/kg day1 The treatment is r
Sponsors
Lung Oncology Group in Kyushu, Japan (LOGIK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) written informed consent (2) It is judged by investigators to be treatable in this protocol (3) age>=20years (4) EGFR wild type mutation * as for the variation that EGFR-TKI does not have the sensitivity, registration is possible(T790M ,exon20 insertion etc) (5) histologically or cytologically proven non-squamous non-small cell lung cancer. after failure to first line therapy, platinum doublet plus bevacizumab * maintenance therapy to follow platinum doublet is regard as a series of first line therapy * EGFR-TKI(2nd-line erlotinib etc) is not regaed as the previous treatment * include a recurrence post-operation. in case of adjuvant chemotherapy, passing until first line therapy more than 6 months * palliative radiation therapy (gamma-knife, irradiation to a bone metastatic ) to any place other than the original lesion genesis can register if there is it more than 2 weeks after the radiation therapy(registration is possible from day 15 as day0 on last treatment day) (6) with measurable lesion(RECIST version 1.1) (7) radical radiation therapy cannot adapt (case of clinical stage of a disease IIIB, IV or recurrence post-operation) * using OK432 for hydrothorax control is possible (8) ECOG PS 0-1 (9) adequate organ function WBC >=4,000/mm3,<=12,000/mm3, Platelet >=100,000/mm3 ,Hb >=9.0 g/dl ,ALT,AST <=2.0 x the Upper Limits of Normal (ULN) (liver metastasis<=3.0 x ULN),T-bilirubin<=1.5 mg/dl , Serum creatinine 1.5 mg/dl ,CCr-60 ml/min, ECG(within normal limit) ,SpO2>=94% , Urine protein<= 1+ or 2 g in urine collection for 24h (10) life expectancy more than 3 months
Exclusion criteria
Exclusion criteria: (1) squamous metastasis (2) activating EGFR sensitive mutation or unknown(sensitive EGFR mutation:G719X, exon19deletion,L858R,L861Q) (3) having serious complications. ex): a serious heart disease , cerebrovascular disorder, diabetes that it is hard to control or hypertention , a severe infection, pulmonary fibrosis, interstitial pneumonia, respiratory failure, bleeding, a large quantity of hydrothorax or abdominal dropsy retention, peptic ulcer of the activity, serious nerve disease (4) symptomatic brain metastasis (5) have an anamnesis and the complications , expectoration of fresh blood more than 2.5 ml due to non-small-cell lung cancer (6) having an anamnesis of the following bloody phlegm or complications * there is the dosage career when bloody phlegm occurring continuously (more than one week) or the anamnesis or the internal use styptic is continuous(the cases that an internal use styptic was necessary for again after having been relieved using an internal use styptic or the bloody phlegm which needs with a history of bloody phlegm, the dosage of the injection styptic to need the dosage or the dosage) (7) current or previous (within the last 1 year) history of GI perforation (8) the operation has been scheduled for the examination period (9) have multiple primary cancer (10) history of serious drug hypersensitivity (11) pregnancy or lactation (12) active psychological disease (13) receives the steroid continuously(p.o. or i.v.) (14) any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate Disease control rate Overall survival Adverse events | — |
Countries
Japan
Contacts
Public ContactTaishi Harada
Kyushu University Hospital respiratory division
Outcome results
None listed