FORTIS-M: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Oral Talactoferrin in Addition to Best Supportive Care in Patients With Non-small Cell Lung Cancer Who Have Failed Two or More Prior Treatment Regimens
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Agennix
- 入组人数
- 742
- 试验地点
- 186
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this study is to determine whether talactoferrin can improve overall survival in patients with non-small cell lung cancer (NSCLC) who have been previously treated with two or more regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed stage IIIB or IV NSCLC
- •Failed at least 2 prior systemic anti-cancer regimens for advanced or metastatic NSCLC
- •At least one target lesion that is unirradiated and measurable by RECIST
- •Adequate hematologic, renal and hepatic function
- •ECOG 0, 1, or 2
- •Able to understand and sign an Informed Consent
排除标准
- •Presence of brain metastases, unless the patient received brain irradiation, including adequate stereotactic radiosurgery, at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 3 weeks prior to randomization
- •Any gastrointestinal tract disease or other medical condition resulting in the inability to take oral medications
- •History of other malignancies except: (i) adequately treated basal or squamous cell carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other curatively treated solid tumor with no evidence of disease for ≥ 5 years
- •Uncontrolled ischemic heart disease, or uncontrolled symptomatic congestive heart failure
- •Serious active infection
- •Psychiatric illness/ social situations that would limit study compliance
- •Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol
- •Concurrent radiotherapy to any site or radiotherapy within 4 weeks prior to randomization or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response)
- •Known HIV positive or on active anti-retroviral therapy
- •Known Hepatitis B surface antigen positive or hepatitis C positive
- •Receipt of any investigational medication within 4 weeks prior to randomization
- •Pregnant or lactating patients, or fertile female patients with a positive pregnancy test, or fertile female patients unwilling to use adequate contraception during treatment and 30 days after completion of treatment
- •Sexually active male patients unwilling to practice contraception while participating on the study and up to 30 days after completion of treatment
- •Legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian
研究组 & 干预措施
1
Talactoferrin alfa (talactoferrin or TLF, also known as recombinant human lactoferrin, rhLF or talactoferrinum alfa) is a recombinant version of the glycoprotein expressed in and purified from Aspergillus niger var. awamori. Talactoferrin is structurally and functionally similar to native human lactoferrin. The structural equivalence of talactoferrin to native human lactoferrin has been demonstrated by a comparison of the 3-dimensional structure, molecular weight, biological activity and other physicochemical properties, and is known to differ only in the nature of glycosylation.
干预措施: Talactoferrin (Drug)
2
Placebo contains the same phosphate-based buffer used as the diluent for the talactoferrin solution. In addition, the placebo will contain FD&C/EU grade dyes suitable for oral use to mimic the color of the vialed drug product.
干预措施: Placebo (Drug)
结局指标
主要结局
Overall survival
时间窗: After the occurence of the required number of events
次要结局
- Progression free survival(At time of final analysis)
- Objective response and disease stablization rate(At time of final analysis)
- Safety and tolerability(At time of final analysis)