An Open-Label Phase 1/2 Study of INCB039110 in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic Non–Small Cell Lung Cancer
The purpose of this study is to evaluate the safety and tolerability of INCB039110 in combination with osimertinib in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC).
* Histologically or cytologically confirmed unresectable locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC.
* Documented evidence of somatic activating mutation in EGFR (eg, G719X, exon 19 deletion, L858R, L861Q) in a tumor tissue sample. If a tissue sample is not available, then EGFR mutation status may be determined from circulating tumor DNA obtained from a blood sample using a validated or approved test kit.
** Phase 1: Subjects must have previously received and progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI). Additional lines of systemic therapy including investigational agents for locally advanced or metastatic NSCLC are allowed.
** Phase 2: Subjects must not have received more than 1 prior line of therapy for locally advanced or metastatic NSCLC. First-line treatment must include an EGFR TKI, and subjects must have documented disease progression during or following treatment. Subjects with disease that progressed more than 6 months after completion of neoadjuvant/adjuvant chemotherapy or chemoradiation therapy are eligible if they received an EGFR TKI as first-line treatment for advanced NSCLC.
* Subjects must have evidence of a T790M mutation in tumor tissue or plasma obtained after disease progression during or after treatment with an EGFR TKI.
* Radiographically measurable or evaluable disease per RECIST v1.1.
Rachel Sanborn, M.D.
- Oncology and Hematology Care Eastside
- Oncology and Hematology Care Westside