Actively Recruiting
A Phase 3 Clinical Study of JMT101 Combined With Osimertinib Versus Osimertinib Alone for First-Line Treatment of Locally Advanced or Metastatic Non-Squamous NSCLC With EGFR Sensitive Mutations
Led by Shanghai JMT-Bio Inc. · Updated on 2024-12-16
516
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of combining JMT101, a recombinant humanized anti-EGFR monoclonal antibody, with osimertinib, an EGFR tyrosine kinase inhibitor, compared to osimertinib alone. This Phase 3, randomized, positive-controlled, open-label study focuses on patients with newly diagnosed locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has EGFR-sensitive mutations. The aim is to assess whether the combination improves treatment outcomes for this specific lung cancer type. Participants receive either JMT101 intravenously every two weeks along with daily oral osimertinib, or osimertinib alone taken orally daily. Each treatment cycle lasts four weeks. This study is designed to compare these two treatment approaches as first-line therapy for the specified lung cancer patients. Treatment and monitoring continue for up to approximately 44 months after the first participant is enrolled. During the study, participants undergo regular assessments including imaging scans evaluated by an independent review committee using RECIST 1.1 criteria to measure progression-free survival and other response rates. Researchers also monitor overall survival, adverse events, and immune responses to JMT101. Laboratory tests assess blood counts, organ function, and antibody levels. The study includes ongoing safety monitoring and long-term follow-up visits to evaluate treatment effects and tolerability.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign the informed consent form
- Age 18 years or older, any gender
- Confirmed diagnosis of unresectable locally advanced or metastatic non-squamous NSCLC (stage IIIB, IIIC, or IV) per IASLC 8th edition TNM staging
- No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC; no recurrence or metastasis within 6 months after prior surgery and adjuvant/neoadjuvant therapy
- At least one measurable lesion per RECIST 1.1 criteria at baseline, radiation naive or progressive after radiotherapy; brain metastases excluded as target lesions
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Expected survival of at least 3 months
- Adequate major organ and bone marrow function within 7 days prior to first dose, including specified hematology, renal, liver, and coagulation parameters
You will not qualify if you...
- Presence of concomitant mutations (ALK, ROS1, KRAS, BRAF, RET, MET, NTRK, HER2) with available targeted treatments or other mutations judged not beneficial for this study
- Use of Chinese patent medicines for lung cancer within 2 weeks before randomization
- Local radiotherapy within 2 weeks or extensive bone marrow irradiation within 4 weeks prior to randomization
- Presence of pericardial effusion except small stable amounts for at least 2 weeks
- Major surgery or severe trauma within 4 weeks before first study treatment or planned major surgery during study
- Meningeal metastases, spinal cord compression, symptomatic or unstable brain metastases unless stable and off steroids for at least 2 weeks
- Asymptomatic brain metastases without indication for immediate curative treatment
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 44 months after enrollment
Participants receive either JMT101 combined with Osimertinib or Osimertinib alone as first-line treatment for advanced or metastatic non-squamous NSCLC with EGFR sensitive mutations.
JMT101 given by intravenous drip once every two weeks and Osimertinib taken orally daily, with treatment cycles every 4 weeks
Trial Site Locations
Total: 1 location
1
Sun Yat sen University Cancer Prevention and Treatment Center
Guangzhou, China
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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