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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


Active: No
Cancer Type: Lung Cancer
Unknown Primary
NCT ID: NCT05338970
Trial Phases: Phase III Protocol IDs: U31402-A-U301 (primary)
NCI-2022-04276
2021-005879-40
jRCT 2021220002
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Daiichi Sankyo
NCI Full Details: http://clinicaltrials.gov/show/NCT05338970

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.

Objectives

Patritumab deruxtecan (HER3-DXd, U3-1402) is an antibody-drug conjugate (ADC) comprising
an anti-HER3 mAb linked to a topoisomerase I inhibitor that is in clinical development
for patients with NSCLC, metastatic breast cancer, and colorectal cancer.

The primary objective of the current study is to compare the efficacy of patritumab
deruxtecan versus platinum-based chemotherapy, as measured by progression-free survival
(PFS) and the key secondary endpoint of overall survival (OS), in participants with
metastatic or locally advanced NSCLC with an EGFR-activating mutation (exon 19 deletion
or L858R) after failure of third-generation (eg, osimertinib, lazertinib, aumolertinib,
alflutinib) EGFR TKI therapy.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.