Trials / Active Not Recruiting
Active Not RecruitingNCT04619004
HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer
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)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 277 (actual)
- Sponsor
- Daiichi Sankyo · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This study will initially randomize participants to one of 2 arms in a 1:1 ratio to receive either a 5.6 mg/kg fixed dose regimen or an up-titration dose regimen of patritumab deruxtecan (HER3-DXd, U3-1402).
Conditions
- Non-Small Cell Lung Cancer Metastatic
- Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Patritumab Deruxtecan (Fixed dose) | Patritumab deruxtecan will be dosed at 5.6 mg/kg as an intravenous (IV) infusion administered on Day 1 of each 21-day cycle. |
| DRUG | Patritumab Deruxtecan (Up-Titration) | Patritumab deruxtecan will be dosed as an intravenous (IV) infusion administered at Cycle 1, 3.2 mg/kg; Cycle 2, 4.8 mg/kg; Cycle 3 and subsequent cycles, 6.4 mg/kg administered on Day 1 of each 21-day cycle. |
Timeline
- Start date
- 2021-02-02
- Primary completion
- 2022-11-21
- Completion
- 2026-07-03
- First posted
- 2020-11-06
- Last updated
- 2026-04-07
- Results posted
- 2024-04-02
Locations
123 sites across 16 countries: United States, Australia, Austria, Belgium, Bulgaria, China, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04619004. Inclusion in this directory is not an endorsement.