REZILIENT3: Randomized phase III study of first-line zipalertinib plus chemotherapy in patients with EGFR exon 20 insertion-mutated NSCLC Journal Article
| Authors: | Heymach, J. V.; Yu, H. A.; Besse, B.; Cheng, Y.; Tan, D. S. W.; Wei, L.; Wacheck, V.; Nishio, M. |
| Article Title: | REZILIENT3: Randomized phase III study of first-line zipalertinib plus chemotherapy in patients with EGFR exon 20 insertion-mutated NSCLC |
| Abstract: | There remains a significant unmet need for effective and tolerable treatments for patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations in the first-line setting. First and later generation EGFR tyrosine kinase inhibitors (TKIs) have shown efficacy for common EGFR mutations; however, their effectiveness against ex20ins mutations is limited, and platinum-based chemotherapy remains part of the standard of care. Data suggest that combining chemotherapy with EGFR inhibitors offers promise for EGFR ex20ins-mutated NSCLC. REZILIENT3 is an ongoing phase III study evaluating the efficacy and safety of zipalertinib (an orally available, irreversible EGFR-TKI) plus first-line standard-of-care platinum-based chemotherapy with chemotherapy alone in previously untreated patients with nonsquamous NSCLC harboring EGFR ex20ins mutations. Clinical Trial Registration: NCT05973773 (ClinicalTrials.gov). © 2025 Informa UK Limited, trading as Taylor & Francis Group. |
| Keywords: | adult; controlled study; treatment response; aged; middle aged; gene mutation; overall survival; exon; genetics; mutation; exons; clinical trial; cisplatin; diarrhea; drug efficacy; drug safety; chemotherapy; antineoplastic agent; carboplatin; progression free survival; quality of life; protein kinase inhibitor; randomized controlled trial; antineoplastic combined chemotherapy protocols; carcinoma, non-small-cell lung; lung neoplasms; epidermal growth factor receptor; pathology; protein tyrosine kinase inhibitor; rash; protein kinase inhibitors; lung tumor; multicenter study; brain metastasis; platinum; phase 3 clinical trial; egfr; drug therapy; pemetrexed; non-small cell lung cancer; disease exacerbation; egfr protein, human; pharmacokinetics; mutagenesis, insertional; paronychia; non small cell lung cancer; nsclc; randomized controlled trial (topic); phase 3 clinical trial (topic); patient-reported outcome; insertional mutagenesis; first-line treatment; triazines; erbb receptors; humans; human; male; female; article; exon 20 insertions; triazine derivative; zipalertinib; ex20ins; nonsquamous nsclc |
| Journal Title: | Future Oncology |
| Volume: | 21 |
| Issue: | 5 |
| ISSN: | 1479-6694 |
| Publisher: | Future Medicine |
| Date Published: | 2025-01-01 |
| Start Page: | 549 |
| End Page: | 556 |
| Language: | English |
| DOI: | 10.1080/14796694.2025.2457294 |
| PUBMED: | 39957151 |
| PROVIDER: | scopus |
| PMCID: | PMC11845107 |
| DOI/URL: | |
| Notes: | Source: Scopus |
