Recurrent Squamous Cell Lung Carcinoma Clinical Trial
Official title:
An Investigator-Sponsored Phase 1/2 Study of Selinexor (KPT-330) and Docetaxel as Second Line Therapy in Patients With Relapsed Squamous Cell Lung Cancer
This phase I/II trial studies the side effects and best dose of selinexor and docetaxel and to see how well they work when given together in treating patients with squamous cell lung cancer that has come back or spread to other places in the body. Selinexor may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving selinexor together with docetaxel may work better in treating squamous cell lung cancer.
PRIMARY OBJECTIVES:
I. To evaluate the toxicity and determine recommended phase II dose of the combination of
docetaxel and selinexor. (Phase I) II. To evaluate the efficacy as measured by progression
free survival (PFS) of docetaxel and selinexor in patients with recurrent/metastatic
squamous cell lung cancer. (Phase I/II)
SECONDARY OBJECTIVES:
I. To evaluate the objective tumor response rate as determined by radiographic response.
II. To evaluated the disease control rate (complete response, partial responses, and stable
disease).
III. To evaluate the overall survival (OS). IV. To evaluate the safety and tolerability of
single agent selinexor.
TERTIARY OBJECTIVES:
I. Lung cancer genomics sequencing panel. II. Tumor biopsy (baseline and cycle 2). III.
Plasma cytokine analysis, peripheral blood ribonucleic acid (RNA) analysis.
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients receive docetaxel intravenously (IV) on day 1 and selinexor orally (PO) twice daily
(BID) on days 1, 3, 7, 9, 13, and 15. Courses repeat every 21 days in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up monthly for 3 months, every 3
months for 9 months, and then every 6 months thereafter.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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