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

StatusActive, Not Recruiting
PhasePhase 3
Started2022-07-08
View on ClinicalTrials.gov ↗

Amendment history

2026-08-25
minor
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v26
Completion pushed: 2026-06-30 → 2026-12-31
Eligibility criteria+12 characters
[...] ced setting, which must include a third -generation EGFR TKI. May have received either neoadjuvant and/or adjuvant treatm [...] ue or pretreatment tumor biopsy, or squamous NSCLC histology. Has any history of interstitial lung disease (ILD) (includi [...] s suspected to have such disease by imaging during Screening. Has clinically severe respiratory compromise (based on the [...] any form of immunosuppressive therapy prior to randomization. Has any history of or evidence of current leptomeningeal disease. Has evidence of clinically active spinal cord compression o [...] costeroids or anticonvulsants to control associate [...]
Secondary endpointsdetails revised at 1 of 18 entries
Study sitesdetails revised at 1 of 182 sites
2025-01-29
minor
Study Status v25
Re-verified, no change to tracked fields
2024-10-31
minor
Study Status v24
Primary completion dateestimated 2024-08-30→confirmed 2024-05-31
2024-08-26
minor
Study Status, Sponsor/Collaborators v23
Collaborators+23 characters
Merck Sharp & Dohme LLC
2024-04-16
minor
Study Status, Outcome Measures v22
Completion date2026-08-04→2026-06-30
Start date2022-05-10→2022-07-08
Secondary endpoints17 to 18 entries
Intracranial PFS as Assessed by BICR
Show 21 earlier versions
2024-01-09
minor
Study Status, Study Design v21
Enrollment target560→586
2023-12-07
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v20
Trial statusRecruiting→Active, Not Recruiting
Study sites188→182
2023-11-15
minor
Study Status, Contacts/Locations v19
Study sitesdetails revised at 2 of 188 sites
2023-09-15
minor
Study Status, Contacts/Locations v18
Study sitesdetails revised at 1 of 188 sites
2023-08-16
minor
Study Status, Contacts/Locations v17
Study sitesdetails revised at 10 of 188 sites
2023-07-18
minor
Study Status, Contacts/Locations v16
Study sites184→188
2023-06-30
minor
Study Status, Outcome Measures, Eligibility v15
Eligibility criteria+61 characters
[...] m^3 or ≥100 × 10^9/L within 14 days prior to the assessment of platelet count during the Screening Period Absolute neutrophil count: ≥1500 [...] m^3 or ≥1.5 × 10^9/L within 14 days prior to the assessment of absolute neutrophil count during the Screening Period Hemoglobin (Hgb): ≥9.0 g/dL within 14 days prior to the assessment of hemoglobin during the Screening Period Creatine clearance (CrCl): CrCl [...]
Secondary endpoints17 entries, revised
Objective Response Rate (ORR) as Assessed by Blinded Independent Central ReviewBICR and Investigator Review Based on RECIST v1.1 Duration of Response (DoR) as Assessed by Blinded Independent Central ReviewBICR and Investigator Review Based on RECIST v1.1 Clinical Benefit Rate (CBR) as Assessed by Blinded Independent Central ReviewBICR and Investigator Review Based on RECIST v1.1 Disease Control Rate (DCR) as Assessed by Blinded Independent Central ReviewBICR and Investigator Review Based on RECIST v1.1 Time to Response (TTR) as Assessed by Blinded Independent Central ReviewBICR and Investigato [...] [...]
Primary endpoints1 entry, revised
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) Based on RECIST v1.1
2023-06-15
minor
Study Status, Arms and Interventions, Eligibility, Contacts/Locations v14
Study sites183→184
Eligibility criteria+223 characters
[...] andomization: Platelet count: ≥100,000/mm^3 or ≥100 × 10^9/L within 14 days prior to the assessment during the Screening Period Absolute neutrophil count: ≥1500/mm^3 or ≥1.5 × 10^9/L within 14 days prior to the assessment during the Screening Period Hemoglobin (Hgb): ≥9.0 g/dL within 14 days prior to the assessment during the Screening Period Creatine clearance (CrCl): CrCl ≥45 mL/min calculated by us [...] form of immunosuppressive therapy prior to randomization Has any history of or evidence of anycurrent leptomeningeal disease Has evidence of clinically active sp [...]
2023-04-17
minor
Study Status, Contacts/Locations v13
Study sitesdetails revised at 29 of 183 sites
2023-03-21
minor
Study Status, Contacts/Locations v12
Study sitesdetails revised at 20 of 183 sites
2023-03-06
minor
Study Status, Contacts/Locations v11
Study sitesdetails revised at 15 of 183 sites
2023-01-17
minor
Study Status, Contacts/Locations v10
Study sitesdetails revised at 13 of 183 sites
2022-12-19
minor
Study Status, Contacts/Locations v9
Study sitesdetails revised at 17 of 183 sites
2022-11-16
minor
Study Status, Contacts/Locations v8
Study sites182→183
2022-10-17
minor
Study Status, Contacts/Locations v7
Study sitesdetails revised at 11 of 182 sites
2022-09-19
minor
Study Status, Contacts/Locations v6
Study sitesdetails revised at 9 of 182 sites
2022-08-15
minor
Study Status, Contacts/Locations v5
Study sitesdetails revised at 8 of 182 sites
2022-07-14
minor
Study Identification, Study Status, Contacts/Locations v4
Study sites179→182
2022-06-30
minor
Study Identification, Study Status, Conditions v3
Study title+17 characters
HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemo [...]
2022-06-16
minor
Study Status, Contacts/Locations v2
Study sites176→179
2022-05-23
minor
Study Status, Contacts/Locations v1
Start date2022-04-13→2022-05-10
Study sites112→176
2022-04-20
minor
Original filing
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 suggests that patritumab deruxtecan constitutes a promising investigational therapy for patients with EGFRm NSCLC.
Trial Details
NCT Number NCT05338970
Lead Sponsor Daiichi Sankyo
Collaborators: Merck Sharp & Dohme LLC
Conditions Nonsquamous Non-small Cell Lung Cancer, EGFR L858R, EGFR Exon 19 Deletion
Enrollment 586 participants
Start Date 2022-07-08
Primary Completion 2024-05-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-27