NCT05338970

HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy

Active, enrolled Phase 3 Last updated 31 January 2025

What this trial tests

Phase 3 trial testing Patritumab Deruxtecan in Nonsquamous Non-small Cell Lung Cancer in 586 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

8 July 2022

Primary endpoint
31 May 2024

30 June 2026

Quick facts

Lead sponsor	Daiichi Sankyo
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	586
Start date	8 July 2022
Primary completion	31 May 2024
Estimated completion	30 June 2026
Sites	182 locations across Hong Kong, Italy, Japan, Taiwan, Poland, South Korea, Netherlands, Belgium

Drugs / interventions tested

• Patritumab Deruxtecan — full drug profile →
• Platinum-based chemotherapy — full drug profile →

Conditions studied

• Nonsquamous Non-small Cell Lung Cancer — all drugs for Nonsquamous Non-small Cell Lung Cancer →
• EGFR L858R — all drugs for EGFR L858R →
• EGFR Exon 19 Deletion — all drugs for EGFR Exon 19 Deletion →

Sponsor

Daiichi Sankyo — full company profile →

Who can join

18 and older, any sex, with Nonsquamous Non-small Cell Lung Cancer or EGFR L858R. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Disease progression is typical for patients with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC). Standard platinum-based chemotherapy offers limited efficacy and an unfavorable safety profile.There is an urgent need for more effective and tolerable therapies for patients with EGFRm NSCLC who have exhausted available targeted therapies. Clinical evidence suggest that patritumab deruxtecan constitutes a promising investigational therapy for patients with EGFRm NSCLC.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Therapeutic strategies for EGFR-mutated non-small cell lung cancer patients with osimertinib resistance.
   Fu K, Xie F, Wang F, Fu L. · · 2022 · cited 271× · PMID 36482474 · DOI 10.1186/s13045-022-01391-4
2. HERTHENA-Lung01, a Phase II Trial of Patritumab Deruxtecan (HER3-DXd) in Epidermal Growth Factor Receptor-Mutated Non-Small-Cell Lung Cancer After Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and Platinum-Based Chemotherapy.
   Yu HA, Goto Y, Hayashi H, Felip E, et al · · 2023 · cited 175× · PMID 37689979 · DOI 10.1200/jco.23.01476
3. Antibodies to watch in 2024.
   Crescioli S, Kaplon H, Chenoweth A, Wang L, et al · · 2024 · cited 122× · PMID 38178784 · DOI 10.1080/19420862.2023.2297450
4. Antibody-Drug Conjugates (ADCs): current and future biopharmaceuticals.
   Wang R, Hu B, Pan Z, Mo C, et al · · 2025 · cited 105× · PMID 40307936 · DOI 10.1186/s13045-025-01704-3
5. Oncogenic alterations in advanced NSCLC: a molecular super-highway.
   Friedlaender A, Perol M, Banna GL, Parikh K, et al · · 2024 · cited 91× · PMID 38347643 · DOI 10.1186/s40364-024-00566-0
6. The Evolving Landscape of Antibody-Drug Conjugates: In Depth Analysis of Recent Research Progress.
   Sasso JM, Tenchov R, Bird R, Iyer KA, et al · · 2023 · cited 89× · PMID 37821099 · DOI 10.1021/acs.bioconjchem.3c00374
7. Antibodies to watch in 2025.
   Crescioli S, Kaplon H, Wang L, Visweswaraiah J, et al · · 2025 · cited 87× · PMID 39711140 · DOI 10.1080/19420862.2024.2443538
8. Datopotamab Deruxtecan in Advanced or Metastatic Non-Small Cell Lung Cancer With Actionable Genomic Alterations: Results From the Phase II TROPION-Lung05 Study.
   Sands J, Ahn MJ, Lisberg A, Cho BC, et al · · 2025 · cited 79× · PMID 39761483 · DOI 10.1200/jco-24-01349