APatinib Plus Chemotherapy vErsus Chemotherapy As First-line Treatment for Advanced NSCLC

Trial details

Who runs it

Sun Yat-sen University

Trial code

NCT03164694

Record updated

10 December 2024

Original description

The purpose of this study is to studying the addition of apatinib with chemotherapy to investigate the efficacy and safety of apatinib in combination with chemotherapy in patients with advanced NSCLC.Read full original descriptionShow less

A Multicenter Phase II Trial of Pemetrexed Plus Carboplatin With or Without Apatinib in Patients With Advanced Non-small Cell Lung Cancer Without EGFR Mutation, ALK Gene Rearrangement, and ROS1 Gene Rearrangement

The purpose of this study is to studying the addition of apatinib with chemotherapy to investigate the efficacy and safety of apatinib in combination with chemotherapy in patients with advanced NSCLC.

Inclusion: Target population is advanced NSCLC (IIIB-IV) without EGFR mutation, ALK gene rearrangement, and ROS1 gene rearrangement; Written informed consent provided; Male and female patients aged ≥18 years, < 75 years; Able to comply with the required protocol and follow-up procedures, and able to receive oral medications; Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; Life expectancy ≥12 weeks; Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level); Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases; Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min; Female subjects should not be pregnant or breast-feeding.

Exclusion: A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study; Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy); Patients with prior radiotherapy; Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease); Known severe hypersensitivity to apatinib or any of the excipients of this product; A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease; History of another malignancy in the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted; Eye inflammation or eye infection not fully treated or conditions predisposing the subject to this; Patient who has active serious infection (e.g. pyrexia of or 38.0℃ over); Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications; Inability to comply with protocol or study procedures.

ClinicalTrials.gov NCT03164694