Advanced Non-small Cell Lung Cancer with Interstitial Pnumonitis
Conditions
Interventions
Four to six cycles of Carboplatin day1(AUC5) plus Nab-Paclitaxel day1,8,15 (100mg/m2) every 4 weeks .
Sponsors
Yushima Lung Cancer Oncology Group(YLOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically confirmed non-small cell lung cancer (if mixed type, judged by major histology) 2)Clinical stageIIIA, IIIB not amenable to curative treatment or stage IV, or post operative reccurence (TNM classification, 7th edition) 3) Eligible with or without EGFR mutation , Eligible with or without ALK translocation 4) Interstitial pneumonitis confirmed by high resolution chest CT (less than 2.5mm slice) eligible pirfenidone or inhalation of NAC without the activity of interstitial pnumonitis eligible secondary interstitial pnumonitis except IIP fill at least 2 of the following radiological findings and eligible judged by central review; honeycoming, traction ectasia, ground-grass opacity, interlobular septal thickening 5) Patients aged 20-79 6) ECOG PS 0-1 7) Patients are excepted to live at least 12 weeks 8) Eligible with or without measurable lesions 9) No prior chemotherapy (eligible; In case of postoperative recurrence, 8 weeks or more than 8 weeks after operation. If performed adjuvant chemotherapy, equal or more than 6 months after the day of the final adjuvant chemotherapy) 10) Adequate organ function, evaluated within 14 days before enrollment WBC >=3,000/mm3 Neu >=1,500/mm3 Plt >=100,000/mm3 Hb>=9.0g/dl AST<=2.5XULN, /ALT<=2.5XULN T.Bil<=1.5mg/dl sCr<=1.5mg/dl PaO2>= 70torr 11) less than Grade 2 peripheral neuropathy 12) Written informed consent from the patients 13) No prior radiation therapy for primary cancer (eligible palliative radiation therapy except primary lesion which has done more than 2 weeks before.
Exclusion criteria
Exclusion criteria: 1) Active double cancer 2) Being suspected acute or sub-acute exacerbation of interstitial pneumonitis. Being experienced acute exacerbation of idiopathic interstitial pneumonia. 3) Receiving steroids or immunosuppressants within 3 month for interstitial pneumonia 4) Patiens has pleural effusion, pericardial effusion and ascites to need dranage 5) Serious complications as follows; History of uncontrollable angina pectoris, acute myocardial infarction or heart faliure, etc within 6 months History of cerebral infarction within 6 months Uncontrollable diabetes mellitus, hypertension and diarrhea Active infectious disease or suspected active infectious disease Other Serious complications (ileus, bleeding tendency , SVC syn. Varicella etc) 6) symptomatic brain metastasis 7) Pregnancy, breast feeding and suspected or wish of pregnancy. Men and women who declined contraception 8) Patients who have serious drug hypersensitivity reaction 9) Patients who have received a radiation therapy in chest 10) Having a schedule of operations 11) Patients whose participation in the trial is judged to be inappropriate because of psychiatric disease or psychiatric symptoms 12) Positive HBs antigen 13) Patients whose participation in the trial is judged to be inappropriate by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment completion rate (>=4cycles) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overrall response rate(ORR), Disease control rate(DCR), Progression free survival(PFS), Overall survival (OS), Safety (frequency of of acute exacerbation of interstitial pneumonitis, frequency of the other adverse effects) | — |
Countries
Japan
Contacts
Public ContactHiroyuki Sakashita
Tokyo Medical and Dental university Department of Integrated Pulmonology (Clinical Oncology)
Outcome results
None listed