RecruitingPhase 3NCT06735391

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

A Phase 3 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


Sponsor

Shanghai JMT-Bio Inc.

Enrollment

516 participants

Start Date

Oct 23, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 3, randomized, positive-controlled, open-label clinical study. The primary objective is to evaluate the efficacy of JMT101 in combination with osimertinib versus osimertinib alone in patients with newly diagnosed locally advanced or metastatic non-squamous NSCLC harboring EGFR-sensitive mutations.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a combination of JMT101 (an EGFR-targeting antibody) plus osimertinib versus osimertinib alone as first-line treatment for advanced non-small cell lung cancer (NSCLC) with an EGFR mutation — a specific genetic change that the cancer depends on to grow. **You may be eligible if...** - You are 18 years of age or older - You have advanced or metastatic non-squamous NSCLC (Stage IIIB, IIIC, or IV) - Your cancer has an EGFR mutation (confirmed by testing) - You have not received any prior systemic treatment for your advanced lung cancer **You may NOT be eligible if...** - You have received prior treatment for advanced lung cancer - Your cancer does not have an EGFR mutation - Your general health is too poor to tolerate treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJMT101

JMT101 is a recombinant humanized anti-EGFR monoclonal antibody.

DRUGOsimertinib

EGFR TKI


Locations(1)

Sun Yat sen University Cancer Prevention and Treatment Center

Guangzhou, China

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NCT06735391