A Phase 2 Study of Carboplatin, Pemetrexed, and Bevacizumab followed by Bevacizumab and Erlotinib maintenance for Non-squamous Non-Small Cell Lung Cancer not harboring EGFR mutations. (HOT1101)

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2011
INTERVENTION: Pemetrexed+Carboplatin+Bevacizumab followed by maintenance Erlotinib+Bevacizumab until disease progression CONDITION: Non‐small cell lung cancer PRIMARY OUTCOME: Progression‐free survival at 6 months SECONDARY OUTCOME: Response rate; Shift ratio to maintenance therapy; Overall survival; Safety INCLUSION CRITERIA: 1)Age: 20‐74 years 2)Histologically or cytrologically confirmed diagnosis of non‐squamous non‐small cell lung cancer (non‐squamous NSCLC). 3)Stage IIIB/IV or postoperative recurrence 4)No prior chemotherapy or post‐operative recurrent disease without adjuvant chemotherapy or with at least one year interval from the last administration of adjuvant chemotherapy. 5)Patients who have measurable lesions. 6)Eastern Cooperative Oncology Group (ECOG) Performance status of 0‐2. 7)Adequate function of main organ. White blood cell count>=3000/mm3 Absolute granulocyte count >= 1500/mm3 Hemoglobin >= 9.0g/dL Platelet count >= 100,000/mm3 Serum bilirubin <= 1.5 mg/dL AST,ALT <100 IU/l Serum creatmine < 1.2 mg/dL or Ccr>=60ml/min PaO2(Room air) >=60Torr (or SpO2>=95%) Proteinuria<1+ 8)Life expectancy more than 3 months 9)Written informed consent
Epistemonikos ID: 3245fe7367f2c0050266e75a9f6f5de3956bdd15
First added on: Aug 22, 2024