Phase 1/2 of TAS3351 in NSCLC patients with EGFRmt
- Conditions
- Patients with Advanced Non-Small Cell Lung Cancer and EGFR Mutations
- Registration Number
- JPRN-jRCT2031220742
- Lead Sponsor
- Calleja Elizabeth
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Locally advanced, non-resectable or metastatic NSCLC
- Have adequate organ function
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
- Has tumor tissue available to allow for analysis of EGFRmt status
Dose Escalation: Has any EGFRmt status
Dose Escalation back-fill part, Dose Expansion and Phase II: Has any sensitizing EGFRmt and a confirmed C797S EGFRmt
- Has measurable disease per RECIST v1.1
- Participating in medical research not compatible with this study
- Symptomatic and unstable CNS metastases
- Have not recovered from prior cancer treatment
- Have a significant cardiac condition
- Are a pregnant or breastfeeding female
- A serious illness or medical condition
- Unable to swallow or digest pills
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Safety<br>- ORR per RECIST v1.1
- Secondary Outcome Measures
Name Time Method