KEY TAKEAWAYS
- The phase III trial aimed to evaluate how well and safely aumolertinib, with or without chemotherapy, works in different pts in the real world compared to osimertinib.
- The primary endpoint is PFS, and the key secondary endpoint is OS.
- The trial is currently recruiting and will include approximately 200 sites globally.
Aumolertinib is a new drug that targets EGFR mutations in lung cancer. The drug is safe and effective in advanced lung cancer pts. Researchers aimed to evaluate how well and safely aumolertinib, with or without chemotherapy, works in different pts in the real world compared to osimertinib.
The study compared aumolertinib + chemo and aumolertinib alone with osimertinib alone for pts with advanced NSCLC having specific EGFR mutations and ECOG PS of ≤2. Eligible pts (stage IIIB, IVA, IVB NSCLC, ex19del, or L858R EGFR mutations alone or with others) will be randomized 2:2:1, stratified by mutation, ECOG PS, and race. Anticipated enrollment is 500 pts (aumolertinib + chemo: 200, osimertinib: 200, aumolertinib: 100).
The study’s primary endpoint is progression-free survival(PFS) by BICR (aumolertinib + chemo vs. osimertinib). The secondary endpoint is overall survival(OS) (aumolertinib + chemo vs. osimertinib). Safety and patient-reported outcomes will be assessed. Exploratory endpoints include resistance mechanisms, CNS efficacy, and exposure-response.
The study recruits globally and will test a new lung cancer drug against a standard treatment. If the new drug is effective, the trial will test its effect on overall survival.
Source: https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.TPS9153
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT05493501
Melissa Lynne Johnson, Vincent A. Miller, Suraj Patel, Yumin Zhao, Li Cheng, Siraj Mahamed Ali, Michael Wooten, and Davey B. Daniel. DOI: 10.1200/JCO.2023.41.16_suppl.TPS9153 Journal of Clinical Oncology 41, no. 16_suppl (June 01, 2023) TPS9153-TPS9153.
