APatinib Plus Chemotherapy vErsus Chemotherapy As First-line Treatment for Advanced NSCLC (NCT03164694) | Clinical Trial Compass
WithdrawnPhase 2
APatinib Plus Chemotherapy vErsus Chemotherapy As First-line Treatment for Advanced NSCLC
Stopped: No patients enrolled.
China0Started 2017-05-20
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* Known severe hypersensitivity to apatinib or any of the excipients of this product.
* Inability to comply with protocol or study procedures.
* A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
* A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease.
* Patients with prior chemotherapy or therapy with systemic anti-tumour th…
What they're measuring
1
Overall survival
Timeframe: 1 year after the last patient is randomized