The purpose of this study is to evaluate the safety and tolerability of itacitinib in combination with osimertinib in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC).
Name: Itacitinib
Description: In Phase 1, itacitinib at a protocol-defined starting dose, with subsequent dose escalation based on protocol-specific criteria. In Phase 2, itacitinib at the recommended dose from Phase 1.Type: DrugItacitinib + osimertinib
Name: Osimertinib
Description: Osimertinib 80 mg once daily (QD)Type: DrugItacitinib + osimertinib
Description: ORR defined as the percentage of subjects who have a confirmed best overall response of complete response (CR) or partial response (PR).
Measure: Phase 2: Objective response rate (ORR) based on RECIST v1.1 Time: Screening and 8-week intervals throughout the study, approximately 2 years.Description: Defined as the percentage of maximal tumor shrinkage observed at the lowest point (nadir) compared with baseline.
Measure: Phase 2: Depth of response (DpR) based on RECIST v1.1 Time: Screening and 8-week intervals throughout the study, approximately 2 years.Single Group Assignment
There are 3 SNPs
- Documented evidence of somatic activating mutation in EGFR (eg, G719X, exon 19 deletion, L858R, L861Q) in a tumor tissue sample. --- L858R ---
- Documented evidence of somatic activating mutation in EGFR (eg, G719X, exon 19 deletion, L858R, L861Q) in a tumor tissue sample. --- L858R --- --- L861Q ---
- 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. --- T790M ---
T790M mutation status from a local laboratory is acceptable; however, a tumor tissue sample or plasma sample suitable for centralized T790M mutation analysis must be available. --- T790M ---
T790M mutation status from a local laboratory is acceptable; however, a tumor tissue sample or plasma sample suitable for centralized T790M mutation analysis must be available. --- T790M --- --- T790M ---
- Any previous use of Janus kinase (JAK) inhibitor, osimertinib, or other EGFR-directed therapy for T790M-mt NSCLC. --- T790M ---