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Fruquintinib/Placebo 5 mg, QD, orally administered under fasting conditions for 3 consecutive weeks followed by one-week off to evaluate the survival benefit of patients with advanced non-squamous NSCLC treated with Fruquintinib.
Full description
This is a randomized, double-blind, placebo-controlled, multi-center Phase III clinical trial in patients with advanced non-squamous non-small cell lung cancer (NSCLC) treated with Fruquintinib who failed 2 lines of systemic chemotherapy or with non-tolerable toxicities.
Approximately 521 subjects will be randomized to Fruquintinib group or placebo group at a ratio of 2:1. Patients in the two groups can receive supportive treatment.
Randomization will be stratified by EGFR gene status (mutant vs. wild type) and history of treatment by VEGF inhibitors (yes vs no) .
All subjects will receive study treatment in 4-week cycles: Fruquintinib/placebo for 3 consecutive weeks, and then one week off. Tumor assessment will be performed every 4 weeks in the first 2 cycles, and every 8 weeks since the 3rd cycle, until disease progression or death. Subsequent anti-neoplastic treatment and survival status will be followed up after disease progression.
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Inclusion criteria
Exclusion criteria
Absolute neutrophil count (ANC) <1.5×109/L, platelet <100×109/L or hemoglobin <9 g/dL within 1 week prior to enrollment;
Serum total bilirubin > 1.5 × upper limit of normal (ULN), alanine transaminase and aspartate aminotransferase >2.5×ULN (according to reference range in each clinical study site); ALT and AST > 5×ULN in patients with liver metastasis;
Clinically significant electrolyte abnormality;
Blood creatinine > ULN and creatinine clearance <60 ml/min;
Urine protein 2+ or more, or urine protein quantification ≥1.0 g/24 h;
Activated partial thromboplastin time (APTT) or/and INR and prothrombin time (PT) > 1.5×ULN (according to reference range in each clinical study site);
Patients with uncontrolled hypertension, systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg after symptomatic treatment;
Patients with left ventricular ejection fraction <50% (echocardiography) in heart function evaluation;
Patients with acute myocardial infarction, severe/unstable angina or coronary bypass surgery within 6 months prior to enrollment; cardiac insufficiency of NYHA II or above;
Patients who have a history of arterial thrombosis or deep venous thrombosis within 6 months prior to enrollment, history or evidence of thrombosis or bleeding tendency regardless of the severity within 2 months prior to enrollment; history of hemoptysis (i.e. coughing blood in bright red color or at least 1/2 teaspoon) within 2 weeks prior to enrollment;
Patients who have a history of stroke and/or transient ischemic attack within 12 months prior to enrollment;
Patients with skin wound, surgical site, wound site, severe mucosal ulcer or fracture without complete healing;
Pregnant or lactating women, or women of child bearing potential with positive pregnancy test result before the first dose;
Patients with child bearing potential who or whose sexual partners are not willing to take contraceptive measures;
Patients with any clinical or laboratory abnormalities unsuitable for participating in this clinical trial according to the investigator's judgment;
Patients with serious psychological or psychiatric disorders which may affect subject compliance in this clinical study;
Patients who are allergic to analogue of Fruquintinib and/or its inactive ingredients.
Primary purpose
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Interventional model
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527 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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