Phase II study of continuation maintenance by use of nab-Paclitaxel and Bevacizumab after induction chemotherapy of Carboplatin and nab-Paclitaxel pulse bevacizumab in chemotherapy-naïve patients with Stage IIIB / IV non-squamous and non-small cell lung cancer

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2013
INTERVENTION: CBDCA and nab‐PTX pulse BEV followed by nab‐PTX pulse BEV CONDITION: Non‐small and non‐squamous cell lung cancer PRIMARY OUTCOME: Progression free survival (PFS) from the beginning of maintenance therapy SECONDARY OUTCOME: Response rate (RR) by RECIST, Disease control rate (DCR), Overall survival (OS), Time to treatment failure (TTF), maintenance rate, PFS from the start of induction therapy, Adverse events, INCLUSION CRITERIA: I) Eligibility criteria for 1st registration 1) Histologically or cytologically proven non‐squamous and non‐small cell lung cancer 2) Stage IIIB/IV without indication for radical thoracic irradiation or recurrence after surgical treatment 3) Naive treatment of cytotoxic chemotherapy and recurrence more than 6 months ago after completion of postoperable adjuvant chemotherapy. OK432 pleurodesis for malignant pleural effusion is acceptable for pretreatment. 4)Eastern Cooperative Oncology Group performance status of 0‐1 5)Age > or = 20 years 6) Tumor has the evaluable lesion. 7) Adequate organ function, Adequate organ function within 2 weeks a) Leukocyte count > or = 3,000/mm3 b) Neutrophil count > or = 1,500/mm3 c) Platelet count > or = 100,000/mm3 d) Hemoglobin concentration > or = 9.0 g/dl e) Total bilirubin level < or = 1.5 mg/dl f) Aspartate aminotransferase and alanine aminotransferase levels < or = 10
Epistemonikos ID: 8d82f1bd42df4258ee7353a5d15f27edeacd863c
First added on: Aug 22, 2024