2023 North America Conference on Lung Cancer (NACLC) - Posters and Abstracts-PP01.088 John Heymach NACLC23 Abstract

PP01.088 John Heymach NACLC23 Abstract

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The REZILIENT3 trial is a phase 3 study that aims to evaluate the efficacy and safety of zipalertinib in combination with chemotherapy in previously untreated patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertions. Currently, platinum-based chemotherapy is the standard of care for these patients, highlighting the need for more effective treatments.<br /><br />Zipalertinib is an oral tyrosine kinase inhibitor that has shown promising activity against EGFR mutations in heavily pretreated patients with EGFR exon 20 insertions-mutant NSCLC. The drug has been granted Breakthrough Therapy designation by the FDA. Combining EGFR tyrosine kinase inhibitors with chemotherapy has shown potential for improved antitumor efficacy in patients with EGFR-mutated nonsquamous NSCLC.<br /><br />The REZILIENT3 trial consists of two parts. Part A will establish the recommended dose of zipalertinib in combination with chemotherapy, while Part B will involve randomizing patients to receive zipalertinib plus chemotherapy or chemotherapy alone. The primary objective of Part A is to assess the safety and tolerability of zipalertinib, while the primary objective of Part B is to evaluate the efficacy in terms of progression-free survival.<br /><br />Secondary endpoints of the study include overall survival, investigator-assessed progression-free survival, objective response rate, duration of response, disease control rate, safety, intracranial efficacy endpoints, and quality of life. The trial aims to enroll 6-12 patients in Part A and 300 patients in Part B.<br /><br />In conclusion, the REZILIENT3 trial is investigating the potential of zipalertinib in combination with chemotherapy as a first-line treatment for patients with nonsquamous NSCLC harboring EGFR exon 20 insertions. The study aims to provide much-needed data on the efficacy and safety of this treatment approach in previously untreated patients.

Keywords

REZILIENT3 trial

zipalertinib

chemotherapy

non-small cell lung cancer

NSCLC

epidermal growth factor receptor

EGFR exon 20 insertions

platinum-based chemotherapy

tyrosine kinase inhibitor

Breakthrough Therapy designation