A randomized study of LAZErtiNib alone versus Lazertinib plus bevaCizumab for Advanced non-small cell lung cancer with epidermal growth factor receptor activating mutations and smoking history

Authors
Category Primary study
Registry of TrialsKorean Clinical Trials Database
Year 2023
INTERVENTION: Drug : Single arm: Lazertinib 240mg, QD, daily Combination arm: Lazertinib 240mg, QD, Daily Plus Bevacizumab: 15mg/kg IV every 3 weeks 1cycle=3weeks, Treatment is maintained until the disease progresses, serious side effects, or the patient withdraws consent. CONDITION: Neoplasms PRIMARY OUTCOME: progression‐free survival SECONDARY OUTCOME: overall survival response rate INCLUSION CRITERIA: 1) Histologically confirmed patients with locally progressive or metastatic non‐small cell lung cancer (IIIB or IV) who have not been diagnosed as squamous cell carcinoma. 2) Patients with one or more measurable lesions in accordance with the RECIST criteria (Version 1.1), tumor lesions located at the previous irradiation site, are considered measurable if progress has been made in those lesions. 3) Patients with institutionalized EGFR mutation (exon 19 deletion or L858R) 4) Patients with a history of smoking, including those who are currently smoking (defined as those who have smoked more than 100 cigarettes in their lifetime) 5) ECOG PS 0‐1 Patient 6) Patients with appropriate hematological functions ANC=1,500/uL, hemoglobin=9.0g/dL, platelet=100,000/uL 7) Patients with adequate liver function Total bilirubin < 1 XUNL, AST (SGOT) and ALT (SGPT) < 2.5 XUNL (If there is an interruption: total bilirubin <3 XUNL, AST (SGOT) and ALT
Epistemonikos ID: e94901f0d12bf29bb973dba844ee570066ace346
First added on: Feb 20, 2024