Neoadjuvant Toripalimab for Clinically Stage II-IIIB Resectable Non-small Cell Lung Cancer with EGFR Mutation and PD-L1 Positive Expression

Inclusion criteria

• ✓. Men and women aged ≥ 18 years old.
• ✓. Baseline tumor tissues have to be obtained through biopsy (percutaneous or transbronchial) or surgery at study center.
• ✓. Histologically confirmed diagnosis of primary non-small lung cancer on non-squamous histology.
• ✓. Pre-treatment stage as clinical II-IIIB (AJCC/UICC 8th Edition) (stage IIIB excludes N3 disease); curative resectability has to be explicitly verified by the experienced surgical investigator.
• ✓. Confirmation by the central laboratory that the tumor harbors EGFR mutations either sensitive mutations, uncommon mutations or complex mutations.
• ✓. Have a PD-L1 tumor proportion score (TPS) ≥ 1% determined by IHC at the central laboratory. In order to balance patients with high PD-L1 expression (≥50%) and low PD-L1 expression (1-49%), we planned to enroll PD-L1 high and low patients at a ratio of 1:1.
• ✓. Have not received prior systemic treatment for NSCLC.
• ✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

Exclusion criteria