Lung Cancer Clinical Trial
Official title:
Efficacy and Safety of Anlotinib Versus Docetaxel in Advanved Non-squamous Non-small-cell Lung Cancer Without EGFR Mutation Who Failed in First-line Platinum-based Doublet Chemotherapy: an Open, Muti-center, Randomized Controlled Trial
This study is conducted to explore the safety and efficacy of anlotinib, a tyrosine kinase inhibitors of Vascular Endothelial Growth Factor Receptor 2(VEGFR)、FGFR(Fibroblast Growth Factor Receptor), Platelet-derived growth factor Receptor(PDGFR) and c-kit, vs docetaxel in advanced Non-squamous Non-small cell lung cancer harbouring wild-type epidermal growth factor receptor (EGFR) .
Status | Not yet recruiting |
Enrollment | 88 |
Est. completion date | November 1, 2020 |
Est. primary completion date | November 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - -= 18 and = 70 years of age. Signed the informed consent form prior to patient entry - Histologically or pathologically confirmed non-squamous non-small cell lung cancer(NSCLC) with stage IV . - Histologically or pathologically confirmed non-squamous non-small cell lung cancer(NSCLC) with stage IV . - Patients who has failed from the first-line Platinum-based Doublet chemotherapy harbouring epidermal growth factor receptor(EGFR) sensitive mutations negetive, confirmed by pathological or blood test results) ),ALK/ROS1 mutation-negative or unknown (For recurrent patients, adjuvant chemotherapy, neoadjuvant chemotherapy or neoadjuvant chemotherapy plus adjuvant were assessed for eligibility, and the last treatment time must be more than 6 months before enrollment) Noted: failed from prior treatment means(1) progress disease confirmed by CT; cannot tolerable from standard treatment, such as hematologic toxicities = level 4; non-hematologic toxicities = level 3;damages of heart/liver/kidney = level 2 in CTC AE 4.0 - Must have at least one measurable lesion as per RECIST 1.1 defined as a lesion that is 10mm in longest diameter imaged by CT scan or MRI;prior topical treatment, such as radiotherapy cryosurgery to the lesions is not allowed in less than 3 months; - Life expectancy =3 months. - Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1. - Toxicity caused by prior anti-cancer treatments was restored to = level 1 in CTC AE (4.0) , except alopecia; - The blood routine examination need to be standard (no blood transfusion and blood products within 14 days, no g-csf and other hematopoietic stimulating factor correction); Hemoglobin(HB)=90 g/L; A Neutrophil count of (ANC)=1.5×10e9/L; A Platelet count of (PLT)=80×10e9/L; A Total bilirubin (TBil) of =1.5 upper normal limitation (UNL); A alanine aminotransferase (ALT) and a aspartate aminotransferase (AST) of =2.5 UNL, in case of liver metastasis ALAT and ASAT=5 UNL; A creatinine (Cr) of =1.5 UNL; a creatinine clearance rate = 60ml/min (Cockcroft-Gault); - The woman patients of childbearing age who must agree to take contraceptive methods during the research and within another 8 weeks after it and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; the man patients who must agree to take contraceptive methods during the research and within another 8 weeks Voluntarily joined the study and signed informed consent, with good compliance and follow-up. Exclusion Criteria: - -Mixed Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer, adenocarcinoma mixed with squamous cell carcinoma - No squamous NSCLC with hemoptysis (>50ml/day); - Treated by taxel or similar drugs in 12months; - symptoms of brain metastases cannot be controlled and treated within less than 2 months - Tumor locate within a distance of less than 5 mm from the large vessels, less than 2 cm from the bronchial tree, or has invaded local large vessels; tumor with cavum or necrotic obviously; - Uncontrolled hypertension (systolic =140mmHg and/or diastolic =90mmHg, despite optimal drug therapy). - Patients with with grade ? myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male = 450 ms, female =470 ms); according to NYHA standard, grade ? ~ ? heart failure, or cardiac color Doppler ultrasound examination showed left ventricular ejection fraction (LVEF) <50%. - Coagulation dysfunction (INR> 1.5, PT> ULN +4s or APTT> 1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment;note: Note: under the premise of International Normalized ratio (INR) of prothrombin time (PT) Less than or equal to 1.5, allow to administrate low-dose heparin (adult daily dose is 06000 ~ 12000 U) or low-dose aspirin (100 mg daily dosage or less) , for prophylactic purposes - Patients whose routine urine tests indicate that urine protein = ++ or verifies that the 24-h urine protein quantitation = 1.0 g. - Patients whose has peripheral neuropathy over level 2 in CTC AE4.0, except trauma. - Patients with respiratory syndrome (difficulty breathing of level 2 or higher ), serous cavity effusion need to surgical treatment ( including pleural of level 2 or higher with respiratory distress and anoxia - Patients who have unhealed wounds or fractures for a long time. - Patients with severe infections , and need to receive systemic antibiotic treatment - Decompensated diabetes or other contraindication with high dose glucocorticoid therapy; - Cirrhosis or decompensated liver disease; active or untreated hepatitis C and/or Hepatitis B virus (HBV) infection(prior hepatitis B history, HBsAg positive and HBV DNA=500IU/mL; HCV RNA positive and hepatic Insufficiency - Has an obvious factor influencing oral drug absorption, such as unable to swallow, chronic diarrhea and intestinal obstruction, etc - Patients who received major surgical operations or experienced severe traumatic injuries, bone fracture, or ulcers within 4 weeks before screening. - Severe weight loss (> 10%) Within 6 weeks before Random - Patients who had obvious hemoptysis (>50ml/day) within 3 months before screening; Patients who experienced bleeding symptoms of clinical significance within 3 months before screening, or with confirmed bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer, baseline occult blood in stool ++ and above, or vasculitis, etc; - Patients who manifested arterial/venous thrombus events, e.g. cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, etc., within 12 months before screening. - Allergic reactions to anotol or excipients in experimental drugs. - Allergic reactions to contrast medium - Patients have participated in other antitumor drug clinical trials Within 4 weeks before enrollment or prepare to receive systemic anti-tumor treatment during the study or Within 4 weeks before randomization - Patients with any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trial. |
Country | Name | City | State |
---|---|---|---|
China | Chengdu fifth people's hospital | Chengdu | |
China | Sichuan cancer hospital | Chengdu | |
China | People's hospital of deyang city | Deyang | Sichuan |
China | People's hospital of guangan city | Guangan | |
China | The affiliated hospital of southwest medical university | Luzhou | |
China | Nanchong central hospital | Nanchong | |
China | Neijing second people's hospital | Neijiang | |
China | Suning central hospital | Suning | |
China | Zigong first people's hospital | Zigong | |
China | Zigong fourth people's hospital | Zigong |
Lead Sponsor | Collaborator |
---|---|
Sichuan Cancer Hospital and Research Institute | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival (PFS) | PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause. | Up to 24 months | |
Secondary | Objective response rate(ORR) | ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1. | Up to 24 months | |
Secondary | Disease Control Rate (DCR) | Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1. | Up to 24 months |
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