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A Phase 1/2 Study of TAS3351 in Patients with Advanced Non-Small Cell Lung Cancer and EGFR Mutations

Phase 1/2 of TAS3351 in NSCLC patients with EGFRmt

Calleja Elizabeth

Taiho Pharmaceutical Co., Ltd.

1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo

th-tas3351_info@taiho.co.jp

Matsubara Kana

Taiho Pharmaceutical Co., Ltd.

1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo

+81-3-3293-2455

th-tas3351_info@taiho.co.jp

Complete

April. 24, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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

Both

Patients with Advanced Non-Small Cell Lung Cancer and EGFR Mutations

TAS3351 will be administered orally, continuous daily dosing, cycles lasting 21 days.

- Safety
- ORR per RECIST v1.1

+81-4-7133-1111

April. 12, 2023

No

IPD data will not be shared according to the Sponsor policy on data sharing.

United States/Germany/France/Netherland