Patients with histologically or cytologically confirmed diagnosis of inoperable locally advanced or recurrent/metastatic non-small cell lung cancer (NSCLC) with EGFR sensitive mutations. Patients must have progressed from or be intolerant to or be unfit for standard treatment, or the standard treatment does not exist;
For dose expansion and Phase II, patients must be willing to provide tumor tissues (archived tumor tissue samples within 2 years or fresh tumor tissues) and/or blood samples for central lab testing;
Measurable or evaluable disease;
Adequate bone marrow, liver, and renal function.
You may not be if
Unstable, symptomatic primary CNS tumors/metastasis or leptomeningeal metastases which are not suitable for enrollment, as judged by investigators;
Pregnancy or lactation;
Other protocol specified criteria.
Clareo Health | A Phase 1/2 Study of BPI-361175 in Subjects With Advanced Solid Tumors