Spots Global Cancer Trial Database for A Phase 2 Study of Osimertinib and S-1 in Treatment Resistant EGFR Mutant NSCLC

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Trial Identification

Brief Title: A Phase 2 Study of Osimertinib and S-1 in Treatment Resistant EGFR Mutant NSCLC

Official Title: A Phase 2 Study of Osimertinib and S-1 in Treatment Resistant EGFR Mutant NSCLC (SOS-1 Study)

Study ID: NCT05773092

Conditions

NSCLC

Interventions

Oral S-1 + Oral Osimertinib

Study Description

Brief Summary: The objective of this study is to determine overall response rate 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 and also the Toxicity by CTCAE 5.0.