Phase 3 Study Comparing JMT101 Plus Osimertinib to Osimertinib Alone as First-Line Treatment for Advanced or Metastatic Non-Squamous NSCLC with EGFR Mutations

What this Trial Is About

Researchers are evaluating the effectiveness of combining JMT101, a recombinant humanized anti-EGFR monoclonal antibody, with osimertinib, an EGFR tyrosine kinase inhibitor, compared to osimertinib alone. This Phase 3, randomized, positive-controlled, open-label study focuses on patients with newly diagnosed locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC that has EGFR-sensitive mutations. The aim is to assess whether the combination improves treatment outcomes for this specific lung cancer type. Participants receive either JMT101 intravenously every two weeks along with daily oral osimertinib, or osimertinib alone taken orally daily. Each treatment cycle lasts four weeks. This study is designed to compare these two treatment approaches as first-line therapy for the specified lung cancer patients. Treatment and monitoring continue for up to approximately 44 months after the first participant is enrolled. During the study, participants undergo regular assessments including imaging scans evaluated by an independent review committee using RECIST 1.1 criteria to measure progression-free survival and other response rates. Researchers also monitor overall survival, adverse events, and immune responses to JMT101. Laboratory tests assess blood counts, organ function, and antibody levels. The study includes ongoing safety monitoring and long-term follow-up visits to evaluate treatment effects and tolerability.

A Clinical Study of JMT101 in Combination With Osimertinib Versus Osimertinib Alone as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR) Sensitive Mutations