Aumolertinib (almonertinib; HS-10296) is a novel third-generation EGFR-TKI showing activity against EGFR-sensitizing mutations and EGFR T790M mutation. The third-generation EGFR-TKI osimertinib has been approved in the adjuvant setting. This study is to studying 3-year aumolertinib as adjuvant therapy to see how well it works in treating patients with resected stage IB-IIIA NSCLC harboring sensitizing EGFR mutations.
Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with advanced non-small cell lung cancer (NSCLC) with EGFR mutations. Aumolertinib (almonertinib; HS-10296) is a novel third-generation EGFR-TKI. Aumolertinib showed activity against EGFR-sensitizing mutations and EGFR T790M mutation. In the phase III AENEAS trial, aumolertinib had improved efficacy to gefitinib with similar safety. In the phase II APOLLO trial, aumolertinib is effective and well-tolerated for patients with advanced NSCLC having an EGFR T790M mutation after disease progression on first- and second-generation EGFR TKI therapy. The third-generation EGFR-TKI osimertinib has been approved in the adjuvant setting. This study is to studying 3-year aumolertinib as adjuvant therapy to see how well it works in treating patients with resected stage IB-IIIA NSCLC harboring sensitizing EGFR mutations.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Aumolertinib 110 mg per day orally for 3 years.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
3-year Disease Free Survival
3-year DFS was defined as the proportion of patients who were disease free at 3 years.
Time frame: 3 years after the last patient is randomized
Disease Free Survival
Disease-free survival was assessed from randomization to disease recurrence or death as a result of any cause.
Time frame: 3 years
Adverse Events
Adverse Events were monitored according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.
Time frame: 2 years after the last patient is randomized
Number of participants with perioperative complications
Number of participants with perioperative complications
Time frame: 2 years
3-year Overall Survival
3-year OS was defined as the proportion of patients who were alive at 3 years.
Time frame: 3 years after the last patient is randomized
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