NCT02917993

An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Non-Small Cell Lung Cancer

An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Itacitinib	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.
DRUG	Osimertinib	Osimertinib 80 mg once daily (QD)

Timeline

• Start date: 2016-12-20
• Primary completion: 2025-12-24
• Completion: 2025-12-24
• First posted: 2016-09-28
• Last updated: 2026-02-09

Locations

31 sites across 4 countries: United States, South Korea, Spain, Taiwan