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Compares treatment options for Locally Advanced or Metastatic Non-squamous NSCLC
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
ClinicalTrials.gov ID: NCT06735391
What this study is testing
What is JMT101?
JMT101 is an investigational medicine, being studied as a potential treatment for locally advanced or metastatic non-squamous nsclc.
Also referred to as Recombinant Humanized Anti-Epidermal Growth Factor Receptor Monoclonal Antibody Injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Be able to understand and voluntarily sign the written informed consent form (ICF);
- Age ≥ 18 years old, male or female;
- Participants with histologically or cytologically (pathology report required) confirmed non-squamous NSCLC that is unresectable and locally advanced...
- Participants who have no prior systemic anti-tumor therapy (including anti-EGFR targeted therapy, chemotherapy, biotherapy, immunotherapy, or any...
- Have at least one measurable lesion that meets the RECIST 1.1 criteria at baseline. Target lesions must be either radiation naive or, if previously...
You likely can't join if
- Participants with concomitant mutations such as ALK, ROS1, KRAS, BRAF, RET, MET, NTRK, and HER2, for which targeted drugs are commercially available...
- Have received Chinese patent medicine preparations for the treatment of lung cancer as an indication within 2 weeks prior to randomization;
- Have received local radiotherapy within 2 weeks prior to randomization; have received more than 30% of bone marrow irradiation or extensive...
- Presence of pericardial effusion (small amount of pericardial effusion stable for ≥ 2 weeks prior to randomization is allowed);
- Major surgery or severe traumatic injury within 4 weeks prior to the first study treatment, or anticipation of major surgery during the study. Some...
- Participants with meningeal metastases; spinal cord compression; symptomatic and unstable brain metastases, unless the participants have completed...
See the full eligibility criteria
- Be able to understand and voluntarily sign the written informed consent form (ICF);
- Age ≥ 18 years old, male or female;
- Participants with histologically or cytologically (pathology report required) confirmed non-squamous NSCLC that is unresectable and locally advanced or metastatic (stage IIIB, IIIC, or IV) according to the International...
- Participants who have no prior systemic anti-tumor therapy (including anti-EGFR targeted therapy, chemotherapy, biotherapy, immunotherapy, or any investigational drug) for locally advanced or metastatic NSCLC and are...
- Have at least one measurable lesion that meets the RECIST 1.1 criteria at baseline. Target lesions must be either radiation naive or, if previously irradiated, there must be evidence of unequivocal disease progression...
- ECOG PS score of 0 or 1;
- Expected survival ≥ 3 months;
- Have major organ and bone marrow functions that meet the following criteria within 7 days prior to the first dose in a non-intervention state: 1) Hematology:
- Absolute neutrophil count (ANC) ≥ 1.5×109/L (prior to the hematology assessment, there is no treatment with cell growth factors within 7 days, and no treatment with long-acting granulocyte colony-stimulating factor...
- Platelets ≥ 90×109/L (there is no platelet transfusion or recombinant human thrombopoietin therapy within 7 days prior to hematology assessment);
- Hemoglobin ≥ 90 g/L (there is no red blood cell transfusion/blood transfusion treatment within 14 days prior to hematology assessment); 2) Renal function: Serum creatinine ≤ 1.5×upper limit of normal (ULN), or...
- International normalized ratio (INR) ≤ 1.5;
- Activated partial thromboplastin time (APTT) ≤ 1.5×ULN;
- Participants with concomitant mutations such as ALK, ROS1, KRAS, BRAF, RET, MET, NTRK, and HER2, for which targeted drugs are commercially available for clinical treatment, who will not benefit from this clinical study...
- Have received Chinese patent medicine preparations for the treatment of lung cancer as an indication within 2 weeks prior to randomization;
- Have received local radiotherapy within 2 weeks prior to randomization; have received more than 30% of bone marrow irradiation or extensive radiotherapy within 4 weeks prior to randomization;
- Presence of pericardial effusion (small amount of pericardial effusion stable for ≥ 2 weeks prior to randomization is allowed);
- Major surgery or severe traumatic injury within 4 weeks prior to the first study treatment, or anticipation of major surgery during the study. Some clinical procedures such as vascular access placement and aspiration...
- Participants with meningeal metastases; spinal cord compression; symptomatic and unstable brain metastases, unless the participants have completed curative treatment, are in stable condition for at least 2 weeks prior...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.