Stage IV Lung Cancer AJCC v8 Clinical Trial
Official title:
A Phase 1b Open-Label, Dose-Escalation, Safety, and Pharmacodynamic Study of Minnelide™ Capsules Given in Combination With Osimertinib in Patients With EGFR Mutated NSCLC
This phase Ib trial tests the side effects and best dose of minnelide when given together with osimertinib for the treatment of non-small cell lung cancer that has spread to other places in the body (advanced) and has a change (mutation) in a gene called EGFR. Minnelide is a biologically inactive compound that can be broken down in the body to produce a drug that rapidly releases the active compound triptolide when exposed to phosphatases in the bloodstream. Sometimes, mutations in the EGFR gene cause EGFR proteins to be made in higher than normal amounts on some types of cancer cells. This causes cancer cells to divide more rapidly. Osimertinib may stop the growth of tumor cells by blocking EGFR that is needed for cell growth in this type of cancer. Minnelide and osimertinib may work better in treating patients with EGFR mutant advanced non-small cell lung cancer.
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of triptolide analog (minnelide) capsules when given in combination with osimertinib. II. To establish the dose of minnelide capsules recommended for future phase II studies when given in combination with full dose osimertinib (recommended phase II dose [RP2D]). SECONDARY OBJECTIVES: I. To observe patients for any evidence of antitumor activity of minnelide capsules by objective radiographic assessment when in combination with osimertinib. II. To determine pharmacodynamic effects of minnelide capsules on heat shock protein (HSP)72 levels when given in combination with osimertinib. EXPLORATORY OBJECTIVES: I. Measure HSP levels, pre/post and during therapy as predictive biomarker. II. Determine levels of minnelide in the blood, and its effect. III. Determine the cell free deoxyribonucleic acid (DNA) in blood as biomarker. IV. Evaluate the microbiome pre-, during-, and post-therapy as potentiator of therapeutic response. V. Determine the exosomes as biomarker. OUTLINE: This is a dose-escalation study of minnelide. Patients receive minnelide orally (PO) once daily (QD) on days 1-21 and osimertinib PO QD on days 1-28. Cycles repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 3 months for 2 years. ;
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