HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy
Lung Cancer
Unknown Primary
18 Years and older, Male and Female
U31402-A-U301 (primary)
NCI-2022-04276
2021-005879-40
jRCT 2021220002
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.
Eligibility
- Is a male or female subject aged =18 years (follow local regulatory requirements if the legal age of consent for study participation is >18 years old).
- Has histologically or cytologically documented metastatic or locally advanced non-squamous NSCLC not amenable to curative surgery or radiation.
- Has documentation of an EGFR-activating mutation detected from tumor tissue or blood sample: exon 19 deletion or L858R at diagnosis or thereafter.
- Received 1 or 2 prior line(s) of an approved EGFR TKI treatment in the metastatic or locally advanced setting, which must include a third -generation EGFR TKI
- May have received either neoadjuvant and/or adjuvant treatment if progression to metastatic or locally advanced disease occurred at least 12 months after the last dose of such therapy and subsequently experienced disease progression on or after third-generation EGFR TKI treatment administered in the metastatic or locally advanced setting.
- Has not received any other prior systemic therapies in the metastatic or locally advanced setting (including chemotherapy, immunotherapy etc) (even if administered in combination with EGFR TKI).
- Has documentation of radiographic disease progression while receiving or after receiving a third generation EGFR TKI for metastatic or locally advanced disease.
- Has at least 1 measurable lesion as per RECIST v1.1 by Investigator assessment.
- Is willing to have a tumor biopsy or provide recently obtained tumor tissue.
- Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening.
- Has adequate bone marrow reserve and organ function based on local laboratory evaluation within 14 days prior to randomization:
- Platelet count: =100,000/mm^3 or =100 × 10^9/L within 14 days prior to the assessment of platelet count during the Screening Period
- Absolute neutrophil count: =1500/mm^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 =45 mL/min calculated by using the Cockcroft-Gault equation or measured CrCl
- Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT): AST/ALT =3× Upper limit of normal (ULN)
- Total bilirubin (TBL): TBL =1.5 × ULN
- Serum albumin: =2.5 g/dL
- Prothrombin time (PT) or Prothrombin time-International normalized ratio (PT-INR) and activated partial thromboplastin time (aPTT)/partial thromboplastin time (PTT): =1.5 × ULN, except for participants receiving coumarin-derivative anticoagulants or other similar anticoagulant therapy who must have PT-INR within therapeutic range as deemed appropriate by the Investigator
Treatment Sites in Georgia
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