Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Talactoferrin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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. | Drug: Talactoferrin<br>* Oral, 1.5 grams twice per day<br>* Other names: rhLF;|
| Placebo Comparator: 2<br>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. | Drug: Placebo<br>* Oral, twice per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | After the occurence of the required number of events | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non Small Cell Lung Cancer, Talactoferrin, Dendritic Cell Recruiter and Activator, Immunomodulatory agent