Clinical Trial: NCT04619004
HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 2| Lead Sponsor: | Daiichi Sankyo |
| Information Provided By: | Daiichi Sankyo |
| Last Update Posted: | 2026-09-01 |
Study Overview
Brief Summary
This study is designed to evaluate the antitumor activity of patritumab deruxtecan in participants with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R) who have received and progressed on or after at least 1 EGFR TKI and 1 platinum-based chemotherapy-containing regimen.
Official Title
HERTHENA-Lung01: A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects With Previously Treated Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer (NSCLC)
Conditions
Non-Small Cell Lung Cancer Metastatic, Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor
Intervention / Treatment
- Drug: Patritumab Deruxtecan (Fixed dose)
- Drug: Patritumab Deruxtecan (Up-Titration)
Other Study ID Numbers
- U31402-A-U201
- 2020-000730-17
- 2024-512238-13-00
Start Date (Actual)
2021-02-02
Primary Completion Date (Actual)
2022-11-21
Study Completion Date (Estimated)
2027-01-04
Enrollment (Actual)
277
Study Type
Interventional
Phase
Phase 2
| Lead Sponsor: | Daiichi Sankyo |
| Information Provided By: | Daiichi Sankyo |
| Last Update Posted: | 2026-09-01 |
Study Overview
Brief Summary
This study is designed to evaluate the antitumor activity of patritumab deruxtecan in participants with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R) who have received and progressed on or after at least 1 EGFR TKI and 1 platinum-based chemotherapy-containing regimen.
Official Title
HERTHENA-Lung01: A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects With Previously Treated Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer (NSCLC)
Conditions
Non-Small Cell Lung Cancer Metastatic, Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor
Intervention / Treatment
- Drug: Patritumab Deruxtecan (Fixed dose)
- Drug: Patritumab Deruxtecan (Up-Titration)
Other Study ID Numbers
- U31402-A-U201
- 2020-000730-17
- 2024-512238-13-00
Start Date (Actual)
2021-02-02
Primary Completion Date (Actual)
2022-11-21
Study Completion Date (Estimated)
2027-01-04
Enrollment (Actual)
277
Study Type
Interventional
Phase
Phase 2