Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT03058094
Brief Summary:
A Phase III, Open-Label, Randomized Multicenter Study to Compare AC0010 and Pemetrexed/Cisplatin in Patients With Advanced NSCLC Who Have Progressed Following Prior EGFR TKI.
Detailed Description:
This is a phase III, open label, randomized study assessing AC0010 (300 mg, BID) versus pemetrexed/cisplatin (4-6 cycles) in patients with advanced NSCLC, who have progressed following prior therapy with EGFR-TKI.
Patients must provide a biopsy for central confirmation of T790M mutation positive. Eligible patients will be randomized (2:1) into AC0010 group or pemetrexed/cisplatin group. Patients in chemotherapy group can cross-over to AC0010 treatment when patients experience disease progression or intolerability of chemotherapy. The primary objective of the study is to compare the PFS of AC0010 and pemetrexed/cisplatin.
Study:
NCT03058094
Study Brief:
Protocol Section:
NCT03058094