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:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-24 @ 3:14 PM
NCT ID:
NCT05773092
Brief Summary:
The objective of this study is to determine best overall response rate (BOR) based on radiological assessment per RECIST v1.1 to combination of S-1 and Osimertinib in treatment-resistant EGFR mutant lung cancer.
Detailed Description:
A lead-in phase of 6 patients will be initiated prior to the formal phase II study. The planned sample size is 27 patients (lead-in and phase II).
The primary objective of the study is to demonstrate that S-1 fixed dose 40 mg BD is safe and effective in EGFR metastatic lung cancer resistant to Osimertinib in terms of best overall response (BOR).
The secondary objective of this study will be to further analyse the Disease Control Rate at stipulated timepoints (6,12 and 24 months), Progression-free survival, Overall Survival, and also the Toxicity by CTCAE 5.0.
Study:
NCT05773092
Study Brief:
Protocol Section:
NCT05773092