Phase II clinical study of nab-PTX for patients with recurrent NSCLC
- Conditions
- advanced non-small cell lung cancer
- Registration Number
- JPRN-jRCTs031180214
- Lead Sponsor
- Kubota Kaoru
- Brief Summary
Both 100 mg/m2 and 70 mg/m2 of nab-paclitaxel monotherapy are active for patients with previously treated advanced NSCLC with better safety profile and numerically favored OS and ORR for 70 mg/m2 dose. Therefore, 70 mg/m2 would be the optimal dose of nab-paclitaxel for NSCLC. nab-PTX 70 mg/m2 should be considered the standard option for patients receiving nab-PTX monotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 81
1) Histologically or cytologically confirmed non-small cell lung cancer.
2) Clinical stage IIIB, IV or post-operative recurrence.
3) Age 20 years or older.
4) ECOG Performance Status (PS) 0 to 1.
5) At least one mesurable lesion according to RECIST version 1.1.
6) Patients treated with at least one platinum regimens
7) With adequate organ function,
-neutrophil count over 1,500 / mm3,
-platelet count over 100,000 / mm3,
-hemoglobin concentration over 9.0 g / dL,
-kidney (creatinine within 1.5 mg / dL),
-liver (AST/ALT within 2.5 times less than ULN,
-total bilirubin within 1.5 mg/dL),
-peripheral neuropathy within Grade1, PaO2over 60 Torr or SpO2 over 94.
8) Life expectancy of more than three months.
9) Provided written consent in person for participation in this study.
1) Patient with previous treatment by paclitaxel.
2) Patient receiving chemotherapies less than 4 weeks or EGFR-TKI within two weeks.
3) Patient receiving definitive radiotherapy for less than 6 weeks or local palliative radiotherapy for less than 2 weeks.
4) Patient with symptomatic brain metastasis.
5) Patient with need of chest drainage for pleural effusion.
6) Active infection.
7) Patient with severe complications.
8) Patient having autoimmune disease to need treatment by the immunosuppressive drug.
9) Patient with active multiple cancers.
10) Female Patient in or having a chance or planning of pregnancy or breast feeding. Male patient in planning to impregnate.
11) History of sever psychological disease.
12) Administering steroid.
13) Any patients judged by the investigator to be unfit to participate in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival
- Secondary Outcome Measures
Name Time Method Overall survival/ Objective response rate/ Adverse events