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

Sponsor
Shanghai JMT-Bio Inc.
Study ID
NCT06735391
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • JMT101 — DRUG
    JMT101 is a recombinant humanized anti-EGFR monoclonal antibody.
  • Osimertinib — DRUG
    EGFR TKI

Study Details

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.

Key Dates

Start date
Oct 23, 2024
Status verified
Dec 2024
Primary completion
Sep 30, 2026
Completion
May 30, 2029

Study Design

Enrollment
516 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: JMT101
    JMT101 6mg/kg,intravenous drip,once every two weeks (Q2W), and osimertinib 80mg,orally,once daily(QD),with every 4weeks as a treatment cycle
  • Experimental: Osimertinib
    Osimertinib 80 mg, orally, QD, with every 4 weeks as a treatment cycle.

Primary Outcome Measure

PFS assessed by the independent review committee (IRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: Up to approximately 44 months after the first participant is enrolled ]

Central Contacts