Actively Recruiting
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
Led by Shanghai JMT-Bio Inc. · Updated on 2024-12-16
516
Participants Needed
1
Research Sites
240 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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
- Histologically or cytologically confirmed non-squamous NSCLC that is unresectable and locally advanced or metastatic (stage IIIB, IIIC, or IV)
- No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC, including targeted therapy, chemotherapy, biotherapy, immunotherapy, or investigational drugs
- If recurrent disease after surgery, no tumor recurrence or metastasis within 6 months after surgery and randomization more than 6 months after adjuvant/neoadjuvant therapy
- At least one measurable lesion meeting RECIST 1.1 criteria at baseline, either radiation naive or progressing after radiotherapy; brain metastases not considered target lesions
- ECOG performance status score of 0 or 1
- Expected survival of 3 months or more
- 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 mutations such as ALK, ROS1, KRAS, BRAF, RET, MET, NTRK, or HER2 that have available targeted treatments
- Use of Chinese patent medicine for lung cancer treatment within 2 weeks prior to randomization
- Local radiotherapy within 2 weeks prior to randomization or extensive bone marrow irradiation within 4 weeks prior to randomization
- Presence of pericardial effusion except stable small amount for at least 2 weeks
- Major surgery or severe trauma within 4 weeks prior to first treatment or planned major surgery during study
- Meningeal metastases or spinal cord compression
- Symptomatic or unstable brain metastases unless stable and not requiring steroids for at least 2 weeks prior to randomization
- Asymptomatic brain metastases only if no immediate treatment needed as assessed by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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