MedTrace Logo

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

NCT06735391 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 516

Last updated 2024-12-16

No results posted yet for this study

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.

Conditions

  • Locally Advanced or Metastatic Non-squamous NSCLC
  • Harboring EGFR Sensitive Mutations NSCLC
  • Previously Untreated Systematically NSCLC

Interventions

DRUG

JMT101

JMT101 is a recombinant humanized anti-EGFR monoclonal antibody.

DRUG

Osimertinib

EGFR TKI

Sponsors & Collaborators

  • Shanghai JMT-Bio Inc.

    lead INDUSTRY

Principal Investigators

  • Li Zhang · Sun Yat sen University Cancer Prevention and Treatment Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-23
Primary Completion
2026-09-30
Completion
2029-05-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06735391 on ClinicalTrials.gov