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

Recruiting Phase 3 Interventional Study
Locally Advanced or Metastatic Non-squamous NSCLC Harboring EGFR Sensitive Mutations NSCLC Previously Untreated Systematically NSCLC
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
516 (estimated)
Sponsor
Shanghai JMT-Bio Inc. · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Be able to understand and voluntarily sign the written informed consent form (ICF); 2. Age ≥ 18 years old, male or female; 3. Participants with histologically or cytologically (pathology report required) confirmed non-squamous NSCLC that is unresectable and locally advanced o…
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