Study on Itacitinib and Osimertinib for Advanced Non-Small Cell Lung Cancer

Inclusion Criteria

• Must be 18 years or older (age limits may vary by country).
• Have a confirmed diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC) that cannot be surgically removed.
• Have a specific mutation in the EGFR gene, confirmed by a tissue or blood test.
• For Phase 1: Must have previously been treated with an EGFR TKI and the cancer has progressed.
• For Phase 2: Must not have had more than one prior treatment for advanced NSCLC, which must have included an EGFR TKI, and the cancer must have progressed during or after this treatment.
• Must have a T790M mutation in the tumor or blood after progression on an EGFR TKI.
• Must have measurable disease according to specific medical criteria.

Exclusion Criteria

• Have known brain metastases unless they are stable and not causing symptoms.
• Have abnormal lab results outside the study's defined range.
• Have significant heart problems or abnormal ECG results.
• Have a history of lung diseases like interstitial lung disease or radiation pneumonitis that required steroids.
• Have had another cancer within the last 2 years, except for certain non-invasive cancers.
• Are currently receiving other cancer treatments.
• Have previously used JAK inhibitors, osimertinib, or other EGFR therapies for T790M mutation NSCLC.