DESTINY-Lung01

Phase 2

Completed

• Conditions: HER2-over-expressing or HER2-mutated unresectable and/or metastatic non-squamous NSCLC

• Registration Number: JPRN-jRCT2080223860
• Lead Sponsor: DAIICHI SANKYO Co.,Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 170

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified