Study on Osimertinib With or Without Chemotherapy Compared to Chemotherapy Alone for Treating EGFRm Positive Non-Small Cell Lung Cancer Before Surgery

Inclusion Criteria

• Must be 18 years or older. In Japan, patients under 20 need consent from themselves and a legal representative.
• Have a confirmed diagnosis of non-squamous NSCLC that can be completely removed by surgery (Stage II - IIIB N2).
• Surgery must be considered possible by a team of specialists, including a thoracic surgeon.
• Be in good general health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have a tumor with specific EGFR mutations that respond to EGFR-TKI treatment.

Exclusion Criteria

• History of lung diseases like interstitial lung disease (ILD) or radiation pneumonitis that needed steroid treatment.
• Have had another cancer, unless it was treated and inactive for at least 2 years, or certain skin cancers and in situ cancers that were treated and inactive.
• Have received pre-operative radiotherapy.
• Have mixed small cell and NSCLC cancer.
• Have certain stages of NSCLC (I, IIIB N3, IIIC, IVA, IVB) or tumors invading major structures like the heart or esophagus.
• Only eligible for limited surgeries like segmentectomies or wedge resections.
• Have had previous treatments for NSCLC, including chemotherapy or EGFR-TKI therapy.
• Currently using medications or supplements that strongly affect liver enzymes, unless stopped 3 weeks before the study.