A Randomized, Double-blind, Parallel Group, Equivalence, Multicenter Phase III Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in patients with Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer - SAMSON-II

Prestige Biopharma Limited0 个研究点目标入组 650 人开始时间: 2019年6月18日最近更新: 2024年4月15日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Prestige Biopharma Limited
入组人数: 650

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Able and willing to give written informed consent.
•2. Aged = 18 years of age.
•3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 and life expectancy >3 months based on Investigator’s judgement.
•4. Histologically confirmed metastatic Stage IV or recurrent non squamous non-small cell lung cancer (NSCLC) that is no longer amendable to curative surgery or local therapy.
•5. At least one measurable lesion according to RECIST v.1.1. as confirmed by CIR; bone-only and brain-only metastases are not allowed. Lesions previously treated with radiotherapy are non-target lesions unless clear progression was documented. Previous results are acceptable if performed within 4 weeks prior to screening.
•6. No first line treatment for metastatic or recurrent disease. Prior systemic therapy and/or radiotherapy for locally advanced disease is permitted if completed = 6 months prior to the diagnosis of relapsing disease.
•7. Tumors without EGFR mutation or ALK receptor alteration. Patients with unknown mutation status or known EGFR mutation or ALK receptor alteration may be included provided the corresponding targeted agent is not available and chemotherapy is the standard of care of the study center.
•8. Adequate hematological function, defined as:
•a. Platelet count: = 100,000/µL without the need for transfusion in the 2 weeks prior to Screening.
•b. Prothrombin time (PT), International normalized ratio (INR) or activated partial thromboplastin time (aPTT) =1.5 x the upper limit of normal (ULN).
•c. Absolute neutrophil count: = 1,500/µL without any medical interventionaltreatment (ie, granulocyte-colony stimulating factors [G-CSFs] and/or herbal remedies).
•d. Hemoglobin: = 9 g/dL, without the need for transfusion in the 2 weeks prior to Screening.
•9. Adequate hepatic function as evidenced by meeting all of the following requirements:
•a. Total bilirubin: = 1.5 x ULN.
•b. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP): = 3 x ULN.
•c. If liver metastases are present, ALT and AST <5 x ULN; if liver and/or bone metastases are present ALP = 5 x ULN.
•10. Adequate renal function, as evidenced by meeting all of the following requirements:
•a. Serum creatinine = 1.5 x ULN and creatinine clearance > 50 mL/minute or estimated glomerular filtration rate (GFR) >50 mL/minute.
•b. Urine dipstick for proteinuria of less than 2+ (other ways of urinalysis are also acceptable); if urine dip stick is = 2+, proteinuria must be < 2 g in 24 hours or an equivalent protein/creatinine ratio of <2000 mg/g creatinine (or < 226.0 mg/mmoL creatinine).
•11. Female patients with childbearing potential (excluding women who have undergone surgical sterilization or menopause. Menopause is defined as the status where no menstrual periods continue for 1 year or more without any other medical reasons), are eligible if they have negative serum pregnancy testing within 7 days
•prior to first dosing and are willing to use an effective method of birth
•control/contraception to prevent pregnancy until 6 months after the end of study. Male patients must consent using effective method of contraception until 6 months after the end of study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 520
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 130

排除标准

•1. Diagnosis of small cell carcinoma of the lung or mixed tumors including small cell
•2. Known ROS-1 positive tumor, except in scenarios where the corresponding target agent is not available, and chemotherapy is the standard of care at the study center. Patients with ROS-1 status not known at all can be considered as eligible for the study.
•3. Tumor cavitation, tumor invading into large blood vessels or close to large vessels
•with high risk of bleeding, according to Investigator's judgment.
•4. Prior therapy with monoclonal antibodies or small molecule inhibitors against VEGF
•5. Prior systemic anticancer therapy, or radiotherapy for locally advanced nsNSCLC if
•completed <6 months prior to the diagnosis of relapsing disease.
•6. Previous malignancy other than NSCLC in the last 5 years except for basal cell carcinoma.
•of the skin or pre-invasive cancer of the cervix.
•7. Known brain metastasis or other CNS metastasis that is either symptomatic or
•untreated. Metastases that have been treated by complete resection and/or
•radiotherapy demonstrating stability or improvement are not an exclusion criterion
•provided they are stable as shown by computed tomography (CT) or magnetic
•resonance imaging (MRI) scan for at least 4 weeks before Screening without evidence
•of cerebral edema. Patients on stable dose of corticosteroids or anticonvulsants are
•8. Any unresolved toxicity > Grade I (except alopecia) from previous anticancer therapy
•(including radiotherapy).
•9. History of hemoptysis (> 1/2 teaspoon per event over the past 6 months) or evidence
•of inherited bleeding diathesis or coagulopathy with the risk of bleeding. Clinically
•non-significant minor bleeding is acceptable.
•10. A significant thrombotic or hemorrhagic event = 6 months prior to Screening (includes
•hemoptysis [> 2.5 mL of red blood], gastrointestinal bleeding, hematemesis, CNS
•hemorrhage, severe epistaxis or vaginal bleeding, cerebral infarction, transient
•ischemic attacks, myocardial infarction, unstable angina, and uncontrolled coronary artery
•11. Clinically serious non-healing wounds, or incompletely healed bone fracture at
•12. Known hypersensitivity to any of the study drugs or their excipients, or history of
•clinically significant atopic allergy (eg, asthma including childhood asthma, urticarial).
•13. Live/attenuated vaccine within 12 weeks prior to the Screening Visit.
•14. History of myocardial infarction (= 6 months prior to Screening), unstable angina, New
•York Heart Association Grade II or greater, congestive heart failure, or serious cardiac
•arrhythmia requiring medication.
•15. History of poorly controlled hypertension or resting blood pressure >150/100 mmHg
•in the presence of a stable regimen of antihypertensive therapy.
•16. Any major surgical procedure (risk of bleeding or wound healing complications) within
•28 days prior to the screening.
•17. History of active gastroduodenal ulcer, abdominal fistula as well as nongastrointestinal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to Screening. However, patient with history of ucler which had been treated could be considered as eligible for the study.
•18. Clinically significant active infection requiring systemic therapy.
•19. Known active Hepatitis B infection (according to local site standards) or active Hepatitis C infection (Hepatitis C virus [HCV] antibody positive); the patient could be included in the study if he/she is HCV RNA ne

研究者

发起方

Prestige Biopharma Limited

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