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

Sponsor
National Cancer Centre, Singapore
Study ID
NCT05773092
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Oral S-1 + Oral Osimertinib — DRUG
    S-1 (40mg) will be given orally twice a day (daily) from Day 1 to 14 (21 day cycle), and Osimertinib (80mg) will be given orally daily continuously.

Study Details

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.

Key Dates

First listed
Mar 17, 2023
Start date
Aug 1, 2023
Status verified
Jun 2026
Primary completion
Oct 24, 2025
Completion
Mar 31, 2028

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention
    Oral S-1 + Oral Osimertinib

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Up to 2 years ]

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