Trials / Recruiting
RecruitingNCT06735391
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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 516 (estimated)
- Sponsor
- Shanghai JMT-Bio Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | JMT101 | JMT101 is a recombinant humanized anti-EGFR monoclonal antibody. |
| DRUG | Osimertinib | EGFR TKI |
Timeline
- Start date
- 2024-10-23
- Primary completion
- 2026-09-30
- Completion
- 2029-05-30
- First posted
- 2024-12-16
- Last updated
- 2024-12-16
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06735391. Inclusion in this directory is not an endorsement.