Non Small Cell Lung Cancer
Conditions
Keywords
Non Small Cell Lung Cancer, Talactoferrin, Dendritic Cell Recruiter and Activator, Immunomodulatory agent
Brief summary
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.
Interventions
DRUGTalactoferrin
Oral, 1.5 grams twice per day
DRUGPlacebo
Oral, twice per day
Sponsors
Agennix
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | After the occurence of the required number of events |
Secondary
| Measure | 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 |
Countries
Australia, Bulgaria, Canada, Czechia, France, Germany, Greece, Hungary, India, Italy, Latvia, Malaysia, Philippines, Poland, Romania, Russia, Singapore, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed