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The main objective of this study is to evaluate the safety and tolerability of BPI-15086.
Full description
The main objective of this study is to evaluate the safety and tolerability of BPI-15086. In addition, the anti-cancer effect of BPI-15086 in EGFR T790M mutation-positive advanced NSCLC patients who have progressed on a previous EGFR tyrosine kinase inhibitor therapy will also be evaluated. Biomarkers related to the efficacy of BPI-15086 will be investigated.
Enrollment
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Inclusion criteria
Histologically or cytologically confirmed, locally advanced or metastatic NSCLC patients, who is not suitable for surgery or radiotherapy
Radiological documentation of disease progression while on a previous continuous EGFR TKI (e.g. icotinib, gefitinib, afatinib, neratinib, dacomitnib, or erlotinib) treatment
Patients must fulfil one of the following:
Confirmation of T790M mutation positive after disease progression on EGFR TKIs
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 and estimated life expectancy of at least 12 weeks
Measurable lesion per Response Evaluation Criteria in Solid Tumors(RECIST1.1)
Adequate bone marrow, hepatic, and renal function
Women: For pre-menopausal women who have a childbearing potential, they must have a pregnancy test within 7 days before starting treatment. The serum or urine pregnancy test must be negative and must be non-lacking; all patients (whether male or female) should be Adequate barrier contraceptive measures during the entire treatment period and 3 months after the end of treatment
Have signed Informed Consent Form
Exclusion criteria
Primary purpose
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36 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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