A Phase III, randomized, open-label, multi-center, safety and efficacy study to evaluate nab®-paclitaxel (Abraxane) as maintenance treatment after induction with nab-paclitaxel plus carboplatin in subjects with squamous cell non-small cell lung cancer (NSCLC) - NA

CELGENE CORPORATIO0 个研究点目标入组 427 人开始时间: 2021年6月8日最近更新: 2021年8月2日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 427

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

•Subjects must satisfy the following criteria to be enrolled in the Induction and Maintenance parts of the study (except if specified at study entry only):
•General and Demographics
•1.Age = 18 years of age the time of signing the ICF.
•2.Understand and voluntarily provide written consent to the ICF prior to conducting any study related assessments/procedures.
•3.Able to adhere to the study visit schedule and other protocol requirements
•Disease Specific
•4.Histologically or cytologically confirmed Stage IIIB or IV squamous cell NSCLC at study entry.
•5.No other current active malignancy requiring anticancer therapy.
•6.Radiographically documented measurable disease at study entry (as defined by the RECIST v1.1 criteria).
•7.No prior chemotherapy for the treatment of metastatic NSCLC at study entry. Adjuvant, neo-adjuvant chemotherapy or chemoradiotherapy with curative intent for non-metastatic disease is permitted providing it was completed 12 months prior to starting the study and without disease recurrence.
•8.Absolute neutrophil count (ANC) = 1500 cells/mm3.
•9.Platelets = 100,000 cells/mm3.
•10.Hemoglobin (Hgb) = 9 g/dL.
•11.Aspartate transaminase (AST/serum glutamic oxaloacetic transaminase [SGOT]), alanine transaminase (ALT/serum glutamic pyruvic transaminase [SGPT]) = 2.5 × upper limit of normal range (ULN) or = 5.0 × ULN if liver metastases.
•12.Total bilirubin = 1.5 × ULN except in cases of Gilbert’s disease and liver metastases.
•13.Creatinine = 1.5 mg/dL.
•14.Expected survival of > 12 weeks for the Induction part of the study.
•15.Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
•16.For Maintenance part of the study, subjects must have received at least one dose of nab-paclitaxel in each of the 4 cycles during Induction
•17.Females of childbearing potential [defined as a sexually mature woman who (1) have not undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or (2) have not been naturally postmenopausal for at least 24 consecutive months (ie, has had menses at any time during the preceding 24 consecutive months)] must:
•a.agree to take a pregnancy test prior to starting study medication and throughout the study participation.
•b.commit to complete abstinence from heterosexual contact, or agree to use medical doctor-approved contraception throughout the study without interruption, and while receiving study medication or for a longer period if required by local regulations.
•Male subjects must:
•c.agree to complete abstinence from heterosexual contact or use a condom during sexual contact with a female of child bearing potential while receiving study medication and within 6 months after last dose of study medication, even if he has undergone a successful vasectomy.
•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 216
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 324

排除标准

•The presence of any of the following will exclude a subject from enrollment into the Induction and Maintenance parts of the study (except if specified at study entry only):
•1.Evidence of active brain metastases, including leptomeningeal involvement (prior evidence of brain metastasis are permitted only if treated and stable and off therapy for
•= 4 weeks prior to first dose of study drug).
•2.Only evidence of disease is non measurable at study entry.
•3.Preexisting peripheral neuropathy of Grade 2, 3, or 4 (per CTCAE v4.0). For the Maintenance part of the study subjects with peripheral neuropathy of Grade 3 and higher are excluded.
•4.Venous thromboembolism (VTE) within 1 month prior to signing ICF. If the subject has a history of VTE earlier than 1 month prior to signing the ICF the event should be resolved, stable and without clinically significant bleeding, such as hematuria, gastrointestinal bleeding or hemoptysis.
•5.Current congestive heart failure (New York Heart Association class II-IV).
•6.History of the following within 6 months prior to first administration of a study drug: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant ECG abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder.
•7.Treatment with any investigational product within 28 days prior to signing ICF.
•8.History of allergy or hypersensitivity to nab-paclitaxel or carboplatin.
•9.Currently enrolled in any other clinical protocol or investigational trial that involved administration of experimental therapy and/or therapeutic devices.
•10.Any other clinically significant medical condition and/or organ dysfunction that will interfere with the administration of the therapy according to this protocol.
•11.Subject has any other malignancy within 5 years prior to randomization. Exceptions are malignancies with a negligible risk of metastasis or death (eg, expected 5-year OS
•> 90%) that were treated with an expected curative outcome such as squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, uteri, non-melanomatous skin cancer, carcinoma in situ of the breast, or incidental histological finding of prostate cancer (TNM stage of T1a or T1b) — all treatments should have been completed 6 months prior to signing ICF.
•12.Subject has received radiotherapy = 4 weeks or limited field radiation for palliation = 2 weeks prior to starting IP, and/or from whom = 30% of the bone marrow was irradiated. Prior radiation therapy to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.
•13.Any condition, including the presence of laboratory abnormalities, that places the subject at unacceptable risk if he/she were to participate in the study.
•14.Any condition that confounds the ability to interpret data from the study.
•15.Pregnant and nursing females.

研究者

发起方

CELGENE CORPORATIO

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