HER2-over-expressing or HER2-mutated unresectable and/or metastatic non-squamous NSCLC
Conditions
Sponsors
DAIICHI SANKYO Co.,Ltd.
AstraZeneca
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >= 20 years old. 2. Pathologically documented unresectable and/or metastatic non-squamous NSCLC. 3. Has relapsed from or is refractory to standard treatment or for which no standard treatment is available. 4. For Cohort 1 and Cohort 1a only: HER2-overexpression (IHC 2+ or 3+) status must be assessed and confirmed from an archival tumor tissue sample. 5. For Cohort 2 only: Documented any known activating HER2 mutation from an archival tumor tissue sample. 6. Presence of at least 1 measurable lesion assessed by the investigator based on RECIST ver. 1.1. 7. Is willing and able to provide an adequate archival tumor tissue sample. 8. Is willing to undergo a tissue biopsy, after the completion of the most recent treatment regimen.
Exclusion criteria
Exclusion criteria: 1. Was previously treated with HER2-targeted therapies, except for pan-HER class tyrosine kinase inhibitors. 2. For Cohort 1 and Cohort 1a only: Has known HER2 mutation. 3. Has an uncontrolled or significant cardiovascular disease 4. Has a medical history of clinically significant lung disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Objective response rate (ORR) ORR assessed by independent central imaging facility review based on RECIST ver. 1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy pharmacokinetics safety Duration of response, disease control rate, progression free survival, overall survival, safety, pharmacokinetics | — |
Countries
Europe, Japan, North America
Contacts
Public ContactContact for Clinical Trial Information
DAIICHI SANKYO Co.,Ltd.
Outcome results
None listed