A Phase III Study to Assess the Effects of Almonertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer

Required: EGFR ex19del, L858R

The tumor harbours one of the two common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19Del, L858R), either alone or in combination with other EGFR mutations including T790M, assessed by cobas® EGFR Mutation Test (Roche Diagnostics) or Xiamen AmoyDx EGFR (ADx-ARMS, Super-ARMS method) kit in site or central laboratory.

Must have received: platinum-based chemotherapy — definitive chemoradiation for Stage III disease

Patients must have received either concurrent chemoradiation or sequential chemoradiation including at least 2 cycles of platinum based chemotherapy and a total dose of radiation of 60 Gy ±10% (54 to 66 Gy).

Must have received: radiation therapy — definitive chemoradiation for Stage III disease

Patients must have received either concurrent chemoradiation or sequential chemoradiation including at least 2 cycles of platinum based chemotherapy and a total dose of radiation of 60 Gy ±10% (54 to 66 Gy).

Cannot have received: EGFR tyrosine kinase inhibitor

Prior treatment with EGFR-TKI therapy

Cannot have received: chemotherapy, radiation therapy, immunotherapy, or investigational agents for NSCLC outside of that received in the definitive setting for Stage III disease

Exception: chemotherapy and radiotherapy in SCRT and CCRT regimens is allowed for treatment of Stage III disease; prior surgery for stage I or II NSCLC allowed; neoadjuvant or adjuvant therapy (non-EGFR TKI) must be completed at least 6 months before enrollment

Prior treatment with any prior chemotherapy, radiation therapy, immunotherapy or investigational agents for NSCLC outside of that received in the definitive setting for Stage III disease (chemotherapy and radiotherapy in SCRT and CCRT regimens is allowed for treatment of Stage III disease). Patients who have previously undergone surgery for stage I or stage II NSCLC can be enrolled. If neoadjuvant or adjuvant therapy (non-EGFR tyrosine kinase inhibitor) is used, neoadjuvant or adjuvant therapy needs to be completed for at least half a year (6 months) before enrollment.