Phase 1/2 of TAS3351 in NSCLC patients with EGFRmt

JRCT ID: jRCT2031220742

Registered date:24/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with Advanced Non-Small Cell Lung Cancer and EGFR Mutations
• Date of first enrollment: 24/04/2023
• Target sample size: 200
• Countries of recruitment: United States,Japan,Germany,Japan,France,Japan
• Study type: Interventional
• Intervention(s): TAS3351 will be administered orally, continuous daily dosing, cycles lasting 21 days.

Outcome(s)

Primary Outcome

- Safety
- ORR per RECIST v1.1

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- 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

Exclude criteria

- 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

Related Information

• Primary Sponsor: Calleja Elizabeth
• Secondary ID(s): NCT05765734