Patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring an acquired C797S epidermal growth factor receptor (EGFR) mutation.
Conditions
Brief summary
Phase 1 Dose Escalation • Safety, including (but not limited to) AEs graded by CTCAE v5.0, and incidence of dose limiting toxicities (DLTs). As supplementary data, preliminary antitumor activity and PK/PD results will be considered., Phase 1 Dose Expansion • ORR per RECIST v1.1 by independent central review (ICR), Phase 2 • ORR per RECIST v1.1 by ICR
Detailed description
Phase 1 Dose Escalation • Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator • Duration of response (DoR), disease control rate (DCR), and time on treatment • Progression free survival and OS (Patients in part A2 only) • PK parameters including but not limited to maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), area under the plasma concentration-time curve (AUC), and terminal elimination halflife (T½), Phase 1 Dose Expansion • AEs, including SAEs, clinical laboratory tests, vital signs, and 12-lead ECGs graded according to CTCAE v5.0 • DoR, PFS, and DCR by ICR • ORR, DoR, PFS, and DCR by Investigator assessment. • Overall survival (OS), Phase 2 • DoR, PFS, and DCR by ICR • ORR, DoR, PFS, and DCR by Investigator assessment • Overall survival (OS) • AEs, including SAEs, clinical laboratory tests, vital signs, and 12-lead ECGs graded according to CTCAE v5.0 • EORTC QLQ-C30 and EQ-5D-5L
Interventions
DRUGTAS3351
Sponsors
Taiho Oncology Inc., Taiho Oncology Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1 Dose Escalation • Safety, including (but not limited to) AEs graded by CTCAE v5.0, and incidence of dose limiting toxicities (DLTs). As supplementary data, preliminary antitumor activity and PK/PD results will be considered., Phase 1 Dose Expansion • ORR per RECIST v1.1 by independent central review (ICR), Phase 2 • ORR per RECIST v1.1 by ICR | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1 Dose Escalation • Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator • Duration of response (DoR), disease control rate (DCR), and time on treatment • Progression free survival and OS (Patients in part A2 only) • PK parameters including but not limited to maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), area under the plasma concentration-time curve (AUC), and terminal elimination halflife (T½), Phase 1 Dose Expansion • AEs, including SAEs, clinical laboratory tests, vital signs, and 12-lead ECGs graded according to CTCAE v5.0 • DoR, PFS, and DCR by ICR • ORR, DoR, PFS, and DCR by Investigator assessment. • Overall survival (OS), Phase 2 • DoR, PFS, and DCR by ICR • ORR, DoR, PFS, and DCR by Investigator assessment • Overall survival (OS) • AEs, including SAEs, clinical laboratory tests, vital signs, and 12-lead ECGs graded according to CTCAE v5.0 • EORTC QLQ-C30 and EQ-5D-5L | — |
Countries
France, Germany, Italy, Netherlands, Spain
Outcome results
None listed