HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer
Active, enrolledPhase 2Results postedLast updated 7 April 2026
What this trial tests
Phase 2 trial testing Patritumab Deruxtecan (Fixed dose) in Non-Small Cell Lung Cancer Metastatic in 277 participants. Participants enrolled and being followed up; not accepting new ones.
18 and older, any sex, with Non-Small Cell Lung Cancer Metastatic or Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR)Primary· Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months
ORR is defined as the proportion of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions based on RECIST v1.1.
Group
Value
95% CI
Patritumab Deruxtecan 5.6 mg/kg
64
Patritumab Deruxtecan Up-Titration
8
Duration of Response (DoR)Secondary· Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months
DoR is defined as the time from the first documented confirmed response (CR or PR) to the date of progression or death due to any cause as assessed by BICR and Investigator per RECIST v1.1, respectively. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
Duration of response (BICR)
Group
Value
95% CI
Patritumab Deruxtecan 5.6 mg/kg
6.0
4.4 – 7.2
Patritumab Deruxtecan Up-Titration
7.1
2.8 – 15.2
Duration of response (Investigator)
Group
Value
95% CI
Patritumab Deruxtecan 5.6 mg/kg
6.9
5.6 – 7.2
Patritumab Deruxtecan Up-Titration
5.1
2.6 – 9.5
Progression-free Survival (PFS)Secondary· Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months
PFS is defined as the time from the start of study treatment to the first documentation of objective progressive disease (PD) per RECIST v1.1 or death due to any cause. PFS will be determined by BICR and by Investigator, respectively.
Progression-free survival (BICR)
Group
Value
95% CI
Patritumab Deruxtecan 5.6 mg/kg
5.5
5.1 – 5.9
Patritumab Deruxtecan Up-Titration
6.7
4.2 – 8.8
Progression-free survival (Investigator)
Group
Value
95% CI
Patritumab Deruxtecan 5.6 mg/kg
5.5
4.2 – 5.7
Patritumab Deruxtecan Up-Titration
5.3
4.0 – 8.2
Objective Response Rate (ORR) as Assessed by the InvestigatorSecondary· Data collected from screening until time of disease progression, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months
ORR is defined as the proportion of participants with a BOR of confirmed CR or confirmed PR as assessed by the Investigator per RECIST v1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
Group
Value
95% CI
Patritumab Deruxtecan 5.6 mg/kg
56
Patritumab Deruxtecan Up-Titration
8
Disease Control Rate (DCR)Secondary· Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months
DCR is defined as the proportion of participants who achieved a BOR of confirmed CR, confirmed PR, or stable disease (SD) as assessed by BICR and by the Investigator per RECIST v1.1, respectively. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
Disease control rate (BICR)
Group
Value
95% CI
Patritumab Deruxtecan 5.6 mg/kg
166
Patritumab Deruxtecan Up-Titration
38
Disease control rate (Investigator)
Group
Value
95% CI
Patritumab Deruxtecan 5.6 mg/kg
169
Patritumab Deruxtecan Up-Titration
37
Time to Tumor Response (TTR)Secondary· Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months
TTR is defined as the time from the start of study treatment to the date of the first documentation of confirmed response (CR or PR) as assessed by BICR and Investigator per RECIST v1.1, respectively. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
Time to response (BICR)
Group
Value
95% CI
Patritumab Deruxtecan 5.6 mg/kg
2.2
± 1.31
Patritumab Deruxtecan Up-Titration
1.7
± 0.61
Time to response (Investigator)
Group
Value
95% CI
Patritumab Deruxtecan 5.6 mg/kg
2.5
± 1.78
Patritumab Deruxtecan Up-Titration
2.1
± 1.09
Best Percentage Change in the Sum of Diameters (SoD) of Measurable TumorsSecondary· Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months
The best percentage change in the SoD of measurable tumors is defined as the percentage change in the smallest SoD from all post-baseline tumor assessments, taking as reference the baseline SoD.
Sum of diameters (BICR)
Group
Value
95% CI
Patritumab Deruxtecan 5.6 mg/kg
-25.66
± 30.39
Patritumab Deruxtecan Up-Titration
-17.48
± 29.54
Sum of diameters (Investigator)
Group
Value
95% CI
Patritumab Deruxtecan 5.6 mg/kg
-20.84
± 27.01
Patritumab Deruxtecan Up-Titration
-11.46
± 29.25
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Patritumab Deruxtecan 5.6 mg/kg
Serious: 90/225 (40%)
Deaths: 114/225
Patritumab Deruxtecan Up-Titration
Serious: 16/50 (32%)
Deaths: 28/50
Serious adverse events (86 terms)
Reaction
System
Patritumab Deruxtecan 5.6 …
Patritumab Deruxtecan Up-T…
Disease progression
General disorders
—
—
Pneumonitis
Respiratory, thoracic and mediastinal disorders
—
—
Anaemia
Blood and lymphatic system disorders
—
—
Pneumonia
Infections and infestations
—
—
Nausea
Gastrointestinal disorders
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
Pleural effusion
Respiratory, thoracic and mediastinal disorders
—
—
Thrombocytopenia
Blood and lymphatic system disorders
—
—
Seizure
Nervous system disorders
—
—
Decreased appetite
Metabolism and nutrition disorders
—
—
Pyrexia
General disorders
—
—
Respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
Vomiting
Gastrointestinal disorders
—
—
Metastases to meninges
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Other recruiting trials for Non-Small Cell Lung Cancer Metastatic
Currently open trials in the same condition.
NCT07144280 — A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previ
· Phase 3
· recruiting
NCT06106802 — Lazertinib & Tepotinib for EGFR Mutant NSCLC in MET Overexpressed or Amplified Who Progressed After Lazertinib Treatment
· Phase 2
· recruiting
Other Daiichi Sankyo trials
Trials by the same sponsor.
NCT07474649 — A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events
· Phase 3
· not yet recruiting
NCT07206472 — A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholestero
· active not recruiting
NCT07220616 — A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies
· Phase 1, PHASE2
· recruiting
NCT07268625 — Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid / Ezetimibe, and Atorv
· Phase 1
· completed
NCT07244341 — A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (
· Phase 1
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Daiichi Sankyo
Last refreshed: 7 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04619004.