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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

NCT05338970 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 586

Last updated 2025-01-31

No results posted yet for this study

Summary

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.

Conditions

  • Nonsquamous Non-small Cell Lung Cancer
  • EGFR L858R
  • EGFR Exon 19 Deletion

Interventions

DRUG

Patritumab Deruxtecan

Intravenous administration, 5.6 mg/kg every 3 weeks (q3W)

DRUG

Platinum-based chemotherapy

Intravenous, pemetrexed 500 mg/m\^2 plus either cisplatin (75 mg/m\^2) or carboplatin (target area under the plasma concentration time curve of 5 \[AUC5\] by using the Calvert formula) q3W

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Leader · Daiichi Sankyo

  • Clinical Scientist · Daiichi Sankyo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-08
Primary Completion
2024-05-31
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • China
  • France
  • Germany
  • Hong Kong
  • Italy
  • Japan
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Singapore
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05338970 on ClinicalTrials.gov