- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05132777
Efficacy and Safety of JMT101 Combined With Osimertinib in Patients With Non-Small Cell Lung Cancer
November 12, 2021 updated by: Shanghai JMT-Bio Inc.
A Phase II, Open Label, Multi-center Study to Assess the Efficacy and Safety of JMT101 Combined With Osimertinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations
This study is a phase II, open label, multi-center study to evaluate the efficacy and safety of JMT101 combined with Osimertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
155
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiugao Yang
- Phone Number: +86-21-60677906
- Email: yangxiugao@mail.ecspc.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age≥18 years.
- Patients with non-irradiable, non-operable, histologically or cytologically confirmed Stage IIIB~IV NSCLC, harboring an EGFR exon 20 insertion mutation (including duplication mutations), who have progressed on or intolerable to prior platinum-based chemotherapy.
- At least 1 measurable lesion according to RECIST 1.1.
- ECOG score 0 or 1.
- Life expectancy≥3 months.
- Adequate organ function(tested within 7 days prior to the first dose): Absolute neutrophil count (ANC)≥1.5×10^9 /L, Platelets≥90×10^9/L, Hemoglobin≥9 g/dL or ≥5.6 mmol/L; Serum creatinine <1.5 × ULN; Total bilirubin ≤1.5×ULN (if liver metastases are present,≤3×ULN), AST and ALT≤3×ULN (if liver metastases are present,≤5×ULN);INR or PT≤1.5×ULN, APTT≤1.5×ULN.
- A female of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose. Any male and female patient of childbearing potential must agree to use effective contraception method throughout the trial period and for another half year after the end of the trial.
- Fully understand and fully informed of this study; must sign and give the written Informed Consent Form (ICF).
Exclusion Criteria:
- Previously received monoclonal antibody therapy targeting EGFR.
- Previous chemotherapy, biotherapy, targeted therapy, immunotherapy or other anti-tumor treatment within 4 weeks prior to the first dose of the study drug, 2 weeks (or 5 half-lives whichever is longer) for using small molecule targeted drugs, 2 weeks for using radiotherapy..
- Treated with other investigational agents within 4 weeks prior to the first dose of the study drug.
- Experienced any major surgery (excluding puncture biopsy) or significant trauma within 4 weeks prior to the first dose.
- Hypersensitivity or intolerance to our study drug or any excipients of the study drug.
- Received strong or moderate inducers of CYP3A4 within 14 days prior to the first dose.
- The adverse reactions of previous antitumor treatment have not yet recovered to Grade≤ 1 based on CTCAE 5.0 or baseline (except for the toxicity without safety risk judged by the investigator, such as alopecia).
- Had untreated central nervous system metastasis or meningeal metastasis.
- History of autoimmune disease, immunodeficiency, including HIV positive, or the presence of other acquired or congenital immunodeficiency, or organ transplantation.
- Active hepatitis B, hepatitis C virus or syphilis infection.
- History of severe cardiovascular disease.
- Have difficulty with swallowing medications, or there is a condition seriously affecting the gastrointestinal absorption as judged by investigators.
- Other malignant tumors diagnosed within 5 years prior to the first dose, with the exception of adequately treated skin basal cell carcinoma, skin squamous cell carcinoma, preinvasive cervical carcinoma or breast cancer that was effectively removed and not requiring or not expected to require other treatment during the study period.
- History of interstitial lung disease, drug-induced interstitial lung disease, radioactive pneumonia requiring steroid treatment, or any evidence of clinical active interstitial lung disease.
- History of other serious systemic diseases, in the judgment of the investigator, that make the subject unfit for the study.
- Alcohol or drug dependence.
- Had an unequivocal history of neurological or psychiatric disorders, including epilepsy or dementia.
- Pregnant or lactating woman.
- Not suitable for this study as determined by the investigator due to other reasons.
- Patients harboring EGFR exon20 insertion mutation and also have other EGFR TKI-sensitizing EGFR mutations, such as G719X mutation in exon 18, exon 19 deletion mutation (19 del), exon 20 T790M or S768I mutation, exon 21 L858R mutation, or L861Q mutation.
- Previously received drugs that developed for EGFR exon20 insertion mutated NSCLC ( such as TAK-788, Poziotinib, DZD9008 or JNJ-61186372); the short-term use is allowed, such as≤2 weeks. Responsive to previous EGFR-TKI treatment (including the best overall response of complete response, partial response, or stable disease last more than 6 months). Previously received PD-1 or PD-L1 monoclonal antibody therapy within 3 months prior to the first dose.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: JMT101 in combination with Osimertinib
|
JMT101, 6 mg/kg, IV infusion once every two weeks (one treatment cycle is 4 weeks).
Osimertinib, 160 mg, Oral administration once daily (one treatment cycle is 4 weeks).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Confirmed Objective Response Rate (ORR) Assessed by Blinded Independent Review Committee (IRC) per RECIST Version 1.1
Time Frame: From the first dose to disease progression or end of study, an average of 1 year
|
From the first dose to disease progression or end of study, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Confirmed ORR Assessed by the Investigator per RECIST Version 1.1
Time Frame: From the first dose to disease progression or end of study, an average of 1 year
|
From the first dose to disease progression or end of study, an average of 1 year
|
|
Duration of Response (DoR)
Time Frame: From the first dose to disease progression or end of study, an average of 1 year
|
From the first dose to disease progression or end of study, an average of 1 year
|
|
Disease control rate (DCR)
Time Frame: From the first dose to disease progression or end of study, an average of 1 year
|
From the first dose to disease progression or end of study, an average of 1 year
|
|
Progression free survival (PFS)
Time Frame: From the first dose to disease progression or end of study, an average of 1 year
|
From the first dose to disease progression or end of study, an average of 1 year
|
|
Overall survival (OS)
Time Frame: From the first dose to death or end of study, an average of 1.5 years
|
From the first dose to death or end of study, an average of 1.5 years
|
|
Incidence of adverse events (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAEV5.0))
Time Frame: From the enrollment until 30 days after the last dose
|
From the enrollment until 30 days after the last dose
|
|
Immunogenicity profile of JMT101
Time Frame: From the enrollment until 30 days after the last dose
|
Blood samples will be collected at specified timepoints to detect the presence of anti-drug antibodies and neutralizing antibodies against JMT101
|
From the enrollment until 30 days after the last dose
|
Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of JMT101.
Time Frame: From the first dose to cycle 3 day 1 (each cycle is 28 days)
|
From the first dose to cycle 3 day 1 (each cycle is 28 days)
|
|
Maximum measured plasma concentration (Cmax) of JMT101.
Time Frame: From the first dose to cycle 3 day 1 (each cycle is 28 days)
|
From the first dose to cycle 3 day 1 (each cycle is 28 days)
|
|
Time to maximum plasma concentration (Tmax) of JMT101.
Time Frame: From the first dose to cycle 3 day 1 (each cycle is 28 days)
|
From the first dose to cycle 3 day 1 (each cycle is 28 days)
|
|
Half-life (T1/2) of JMT101.
Time Frame: From the first dose to cycle 3 day 1 (each cycle is 28 days)
|
From the first dose to cycle 3 day 1 (each cycle is 28 days)
|
|
Cl/F of JMT101.
Time Frame: From the first dose to cycle 3 day 1 (each cycle is 28 days)
|
From the first dose to cycle 3 day 1 (each cycle is 28 days)
|
|
Detection of cancer-related biomarkers in circulating tumor DNA from plasma to analyse the corcorrelation with clinical efficacy and drug resistance.
Time Frame: From the enrollment to disease progression, an average of 1 year
|
From the enrollment to disease progression, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 20, 2021
Primary Completion (Anticipated)
September 30, 2023
Study Completion (Anticipated)
September 30, 2024
Study Registration Dates
First Submitted
November 1, 2021
First Submitted That Met QC Criteria
November 12, 2021
First Posted (Actual)
November 24, 2021
Study Record Updates
Last Update Posted (Actual)
November 24, 2021
Last Update Submitted That Met QC Criteria
November 12, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Osimertinib
Other Study ID Numbers
- JMT101-CSP-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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