Advanced non-small-cell lung cancer
Conditions
Interventions
nab-Paclitaxel plus S-1therapy as a third- or fourth-line therapy in patients with previously treated advanced or recurrent non-small cell lung cancer
Sponsors
Depatment of Thoracic Oncology Osaka Medical Center for Cancer and Cardiovascular Diseases
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Histologically or Cytologically documented non-small-cell lung cancer (2)Stage IIIB without any indications for operation and radiotherapy or Stage IV (3)Have measuarable lesion by using the RECIST ver1.1 (Response Evaluation Criteria In Solid Tumors) criteria. (4)The lesions included in the radiation site are not measurable. (5)recurrent or refractory disease after two or three previous treatment regimens (including one platinum regimen regimen at least) (6)one regimen as ALK inhibitor or EGFR-TKI monotherapy (7)Adjuvant chemotherapy, including platinum doublet (but not counted as a regimen for one year after the final treatment) shall be one regimen. UFT is not counted as one regimen. (8)It is acceptable even if patients received paclitaxel, S-1 or nab-PTX as a pre-treatment. But if they received S-1 as a pre-treatment, they have to take at least one treatment-free TS1. (9)Must be 20 or more years old at tne time of consent (10)Have Eastern Coopperative Oncology Group Perfoemance Status (ECOG PS) 0-2 (11)The case can eat. (12)Have adequate organ function within two weeks before study entry. (13)Estimate life expectancy of at least 3 months (14)Have signed an informed consent document
Exclusion criteria
Exclusion criteria: (1)Presencee of other active malignancy (2)SVC syndrome (3)Myocardial infarction, which was developed within six months (4)Liver chirrosis (5)With interstitial pneumonia or pulmonary fibrosis on a chest X-ray (6)Clinically significant drug allergy (7)With severe infection, gastrointestinal hemorrhage or cardiac diseases (8)With persistent diarrhea (9)With with intestinal paralysis or ileus (10)Diabetes with poor control (11)With pericardial effusion, pleural effusion and ascites in need of treatment of drainage (12)Patients received palliative radiotherapy for brain metastases and bone metastases, except for the primary lesion within 2weeks. (13)Symptomatic brain metastasis (14)Peripheral neuropathy of Grade2 or more (15)Positive serum HBs antigen (16)Uncontrolled psychiatric diseases (17)Pregnancy or lactating patients (18)with a history of hypersensitivity to nab-PTX, S-1, paclitaxel, or albumin (19)Others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I:Recomended dose Phase II:Disease control rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, Progression free survival, Overall survival, Adverse events | — |
Countries
Japan
Contacts
Public ContactKazumi Nishino
Osaka Medical Center for Cancer and Cardiovascular Diseases Depatment of Thoracic Oncology
Outcome results
None listed