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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 3
Contacts and Locations
Study Contact
Study Contact
- Name: Clinical Trials Information Group Officer
- Phone Number: 86-0311-69085587
- Email: ctr-contact@cspc.cn
Study Locations
-
-
-
Guangzhou, China
- Recruiting
- Sun Yat sen University Cancer Prevention and Treatment Center
-
Contact:
- Li Zhang
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion 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 Association for the Study of Lung Cancer (IASLC) 8th edition TNM staging criteria.
- 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 not amenable to radical surgery or radiotherapy. For participants with recurrent disease after prior surgical treatment who have undergone prior adjuvant and neoadjuvant therapy, it is necessary to confirm that there is no recurrence or metastasis of tumor within 6 months after surgery, and the randomization is > 6 months from the end of adjuvant/neoadjuvant therapy;
- 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 after radiotherapy. Brain metastases should not be considered as target lesions;
- 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 (G-CSF) or pegylated recombinant human granulocyte colony-stimulating factor (PEG-CSF) within 14 days);
- 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 creatinine clearance (CrCL) ≥ 50 mL/min (using the Cockcroft-Gault formula); 3) Liver function:
a. Total bilirubin ≤ 1.5×ULN (or ≤ 3×ULN for participants with Gilbert syndrome or metastases to liver); b. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN (or AST and ALT ≤ 5×ULN for participants with metastases to liver); 4) Coagulation function:
- International normalized ratio (INR) ≤ 1.5;
- Activated partial thromboplastin time (APTT) ≤ 1.5×ULN;
Exclusion Criteria:
- 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 as judged by the investigator; or participants with other mutations who will not benefit from this clinical study as judged by the investigator;
- 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 biopsy are allowed;
- 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 to randomization and do not require steroid therapy. Participants with asymptomatic brain metastases may be enrolled if the investigator assesses that there is no indication for immediate curative treatment;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
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
|
JMT101 is a recombinant humanized anti-EGFR monoclonal antibody.
Other Names:
|
|
Experimental: Osimertinib
Osimertinib 80 mg, orally, QD, with every 4 weeks as a treatment cycle.
|
EGFR TKI
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
Up to approximately 44 months after the first participant is enrolled
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall survival (OS)
Time Frame: Up to approximately 44 months after the first participant is enrolled
|
Up to approximately 44 months after the first participant is enrolled
|
|
Objective response rate (ORR) assessed by IRC based on RECIST 1.1
Time Frame: Up to approximately 44 months after the first participant is enrolled
|
Up to approximately 44 months after the first participant is enrolled
|
|
duration of response (DOR) assessed by IRC based on RECIST 1.1
Time Frame: Up to approximately 44 months after the first participant is enrolled
|
Up to approximately 44 months after the first participant is enrolled
|
|
disease control rate (DCR) assessed by IRC based on RECIST 1.1
Time Frame: Up to approximately 44 months after the first participant is enrolled
|
Up to approximately 44 months after the first participant is enrolled
|
|
DOR assessed by the investigator based on RECIST 1.1
Time Frame: Up to approximately 44 months after the first participant is enrolled
|
Up to approximately 44 months after the first participant is enrolled
|
|
ORR assessed by the investigator based on RECIST 1.1
Time Frame: Up to approximately 44 months after the first participant is enrolled
|
Up to approximately 44 months after the first participant is enrolled
|
|
DCR assessed by the investigator based on RECIST 1.1
Time Frame: Up to approximately 44 months after the first participant is enrolled
|
Up to approximately 44 months after the first participant is enrolled
|
|
Adverse events incidence and severity
Time Frame: Up to approximately 44 months after the first participant is enrolled
|
Up to approximately 44 months after the first participant is enrolled
|
|
Serum concentration of JMT101
Time Frame: Up to approximately 44 months after the first participant is enrolled
|
Up to approximately 44 months after the first participant is enrolled
|
|
Incidence and titer of anti-drug antibodies (ADAs)
Time Frame: Up to approximately 44 months after the first participant is enrolled
|
Up to approximately 44 months after the first participant is enrolled
|
|
The incidence of neutralising antibodies (NAbs)
Time Frame: Up to approximately 44 months after the first participant is enrolled
|
Up to approximately 44 months after the first participant is enrolled
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Li Zhang, Sun Yat sen University Cancer Prevention and Treatment Center
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Immune System Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Hypersensitivity
- Carcinoma, Non-Small-Cell Lung
- Tyrosine Kinase Inhibitors
- Antineoplastic Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protein Kinase Inhibitors
- Osimertinib
Other Study ID Numbers
Other Study ID Numbers
- JMT101-018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.