Phase II Study of Carboplatin+nab-Paclitaxel for Non-small Cell Lung Cancer with Interstitial Pneumonitis

UMIN ID: UMIN000015662

Registered date:12/11/2014

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Advanced Non-small Cell Lung Cancer with Interstitial Pnumonitis
• Date of first enrollment: 2014/11/12
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Four to six cycles of Carboplatin day1(AUC5) plus Nab-Paclitaxel day1,8,15 (100mg/m2) every 4 weeks .

Outcome(s)

• Primary Outcome: Treatment completion rate (>=4cycles)
• Secondary Outcome: 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)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Yushima Lung Cancer Oncology Group(YLOG)
• Source(s) of Monetary Support: Department of Integrated Pulmonology, Tokyo Medical and Dental university