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HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started2021-02-02
View on ClinicalTrials.gov ↗

Amendment history

2026-08-28
Study Status v48
Re-verified, no change to tracked fields
2026-06-26
Study Status v47
Completion date2027-01-06→2027-01-04
2026-06-09
Completion pushed: 2026-07-03 → 2027-01-06
2026-05-13
Study Status v46
Completion date2026-07-03→2027-01-06
2026-05-12
Study Identification, Study Status, Contacts/Locations v45
Study sitesdetails revised at 4 of 123 sites
2026-03-17
Study Status, Contacts/Locations, Outcome Measures (Results) v44
Completion pushed: 2026-01-30 → 2026-07-03
Study sitesdetails revised at 4 of 123 sites
2026-01-06
Study Status, Contacts/Locations v43
Study sitesdetails revised at 4 of 123 sites
2025-05-16
Study Status, Contacts/Locations v42
Study sites124→123
2024-12-02
3 amendments v39-v41
3 re-verifications since 2024-08-29, no change to tracked fields
2024-08-26
Study Status, Sponsor/Collaborators v38
Collaborators1 to 2 entries
Merck Sharp & Dohme LLC
2024-07-30
Study Status v37
Completion date2024-11-01→2026-01-30
2024-07-19
2 amendments v35-v36
2 re-verifications since 2024-06-20, no change to tracked fields
2024-05-16
Study Status, Contacts/Locations v34
Study sites123→124
2024-03-04
Study Status, Study Design, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v33
Primary completion dateestimated 2024-06-30→confirmed 2022-11-21
Results first postednot stated→2024-04-02
Enrollment targetestimated 420→confirmed 277
Secondary endpoints8 entries, revised
Best percentagePercentage changeChange in the sumSum of diametersDiameters (SoD) of measurableMeasurable tumorsTumors Incidence of treatmentTreatment emergentEmergent adverseAdverse eventsEvents (TEAEs), seriousSerious adverseAdverse eventsEvents (SAEs), and adverseAdverse eventsEvents of specialSpecial interestInterest (AESIs)
2024-01-26
Study Status, Contacts/Locations v32
Completion date2024-11→2024-11-01
Study sites124→123
2023-11-14
Study Status, Contacts/Locations v31
Study sites123→124
2023-09-12
Study Status v30
Primary completion date2023-11-10→2024-06-30
Completion date2024-07→2024-11
2023-09-01
Study Status, Contacts/Locations v29
Study sites121→123
2023-06-15
Study Status v28
Re-verified, no change to tracked fields
2023-01-12
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v27
Trial statusRecruiting→Active, Not Recruiting
Study sites122→121
2022-11-21
Study Status v26
Re-verified, no change to tracked fields
2022-10-10
Study Status, Contacts/Locations v25
Study sitesdetails revised at 3 of 122 sites
2022-09-07
Study Status, Contacts/Locations v24
Study sitesdetails revised at 2 of 122 sites
2022-08-03
Study Status, Contacts/Locations v23
Study sites121→122
2022-07-25
Study Status, Contacts/Locations v22
Study sites122→121
2022-07-05
Study Status, Contacts/Locations v21
Study sitesdetails revised at 1 of 122 sites
2022-06-29
Study Status, Contacts/Locations v20
Study sitesdetails revised at 2 of 122 sites
2022-05-27
Study Status, Contacts/Locations v19
Study sitesdetails revised at 2 of 122 sites
2022-05-10
Study Status, Contacts/Locations v18
Study sitesdetails revised at 1 of 122 sites
2022-04-28
Study Status, Contacts/Locations v17
Study sites129→122
2022-04-20
Study Status, Contacts/Locations v16
Study sitesdetails revised at 1 of 129 sites
2022-04-08
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v15
Trial statusActive, Not Recruiting→Recruiting
Study sites126→129
2022-03-03
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v14
Trial statusRecruiting→Active, Not Recruiting
Study sites129→126
2022-02-11
Study Status, Contacts/Locations v13
Study sites118→129
2022-02-04
Study Status v12
Re-verified, no change to tracked fields
2022-01-07
Study Status, Contacts/Locations v11
Study sites112→118
2021-11-11
Study Status, Contacts/Locations v10
Study sites91→112
2021-08-10
Study Status, Contacts/Locations v9
Study sites92→91
2021-08-05
Study Status, Contacts/Locations v8
Study sites87→92
2021-07-09
Study Status v7
Re-verified, no change to tracked fields
2021-06-08
Study Status, Contacts/Locations v6
Study sites86→87
2021-05-06
Study Status, Contacts/Locations v5
Study sites84→86
2021-04-29
Study Status, Arms and Interventions, Eligibility, Contacts/Locations v4
Study sites78→84
Eligibility criteria+229 characters
[...] ase. Participants must have received both of the following: ≥ 1 prior line(s) of EGFR TKIPrior treatment (erlotinib, gefitinib, afatinib, dacomitinib orwith osimertinib). Participants receiving an EGFR TKI at the time of signing informed consent should continue to take the EGFR TKI until 5 days prior to Cycle 1 Day 1. Participants in South Korea known to harbor a clinically actionable genomic alteration in addition to EGFR T790M mutation-positive participants (previously treated with erlotinibe.g., gefitinib,anaplastic afatiniblymphoma kinase [ALK] or dacomitinibROS1 protocol oncogene 1 [ROS1] [...] [...]
2021-03-06
Study Status, Contacts/Locations v3
Study sites77→78
2021-02-04
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-01→confirmed 2021-02-02
Study sitesdetails revised at 77 of 77 sites
2021-01-20
Study Status, Study Design, Outcome Measures, Eligibility, Contacts/Locations v1
Start date2020-12-05→2021-01
Enrollment target300→420
Study sites0→77
Eligibility criteria+170 characters
[...] atoid arthritis, Sjogren's syndrome, sarcoidosis); OR prior complete pneumonectomy. Is receiving chronic systemic corticosteroids dosed at >10 mg prednisone or equivalent anti-inflammatory or any form of immunosuppressive therapy prior to enrollment. Participants who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in th [...] n EGFR TKI), <14 days or 5 half-lives, whichever is longer; Monoclonal antibodies, other than immune checkpoint inhibitors, such as bevacizumab (anti-VEGF) and cetuximab (anti-EGFR) <28 days; Immune checkpoint inhibitor th [...]
Secondary endpointsdetails revised at 6 of 8 entries
2020-11-05
Original filing
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.
Trial Details
NCT Number NCT04619004
Lead Sponsor Daiichi Sankyo
Collaborators: Daiichi Sankyo Co., Ltd., Merck Sharp & Dohme LLC
Conditions Non-Small Cell Lung Cancer Metastatic, Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor
Enrollment 277 participants
Start Date 2021-02-02
Primary Completion 2022-11-21 (estimated)
Study Completion 2027-01-04 (estimated)
Updated on ClinicalTrials.gov 2026-09-01