Stage IV Non-small Cell Lung Cancer Clinical Trial
Official title:
A Phase Ib Immunomodulatory Study of Single Agent Talactoferrin in Patients With Select Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC) and Squamous Head and Neck Cancer (HNSCC)
This phase I trial studies how well talactoferrin works in treating patients with relapsed or refractory non-small cell lung cancer (NSCLC) or squamous cell head and neck cancer. Biological therapies, such as talactoferrin, may stimulate the immune system in different ways and stop tumor cells from growing
PRIMARY OBJECTIVES:
I. Monitoring of immunologic response to therapy in tumor tissue and peripheral blood.
Identification of potential candidate biomarkers indicating clinical benefit to
talactoferrin.
SECONDARY OBJECTIVES:
I. Progression free survival (PFS), objective response rate (ORR), stable disease (SD),
overall survival (OS), disease stability, and disease stability at 7 weeks.
OUTLINE:
Patients receive talactoferrin orally (PO) twice daily (BID) for 12 weeks. Courses repeat
every 14 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up monthly for at least 12
months.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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