JMT101 Combined With Osimertinib in Patients With Stage Ⅲb-Ⅳ Non-small Cell Lung Cancer (NSCLC) C… (NCT06391944) | Clinical Trial Compass
Active — Not RecruitingPhase 2
JMT101 Combined With Osimertinib in Patients With Stage Ⅲb-Ⅳ Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Common Mutations
China161 participantsStarted 2021-11-21
Plain-language summary
This was a multicenter, open-label phase 2 study. This study aimed to evaluate the efficacy and safety of JMT101 combined with Osimertinib in participants with local advanced or metastatic non-small-cell lung cancer harbouring EGFR common mutation with or without prior systemic therapy.
Efficacy indexes included investigator-assessed Overall Response Rate(ORR), Disease Control Rate(DCR), Duration of Response( DoR), Progression Free Survival (PFS) per RECIST 1.1 and Overall Survival (OS). Safety indexes included Adverse Events incidence and severity. This study included 4 cohorts, cohort 1 included EGFR-mutated advanced NSCLC patients without prior systemic therapy and accepted JMT101 6mg/Kg Q3W and Osimertinib 80mg QD therapy. Cohort 2 included EGFR-mutated advanced NSCLC patients who failed with prior generation 1 or 2 EGFR-TKIs therapy and accepted JMT101 6mg/Kg Q2W and Osimertinib 80mg QD therapy. Cohort 3 included advanced EGFR common mutation NSCLC patients who failed with prior generation 3 EGFR-TKIs but did not accept chemotherapy and accepted JMT101 6mg/Kg Q2W and Osimertinib 80mg or 160mg QD therapy. Cohort 4 included EGFR-mutated advanced EGFR NSCLC patients who failed with prior generation 3 EGFR-TKIs and platinum-based chemotherapy and accepted JMT101 6mg/Kg Q2W and Osimertinib 80mg or 160mg QD therapy.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age between 18-75 years old.
. Histologically or cytologically confirmed diagnosis of NSCLC, locally advanced (Stage IIIB and IIIC according to the 8th edition of the AJCC TNM staging criteria) or metastatic (Stage IV) harbouring EGFR common mutation with tumour tissue/blood sample. For cohort 1, should not receive prior systemic therapy, for cohort 2, should fail with generation 1 or 2 EGFR-TKIs therapy, for cohort 3, should fail with generation 3 EGFR-TKIs therapy but did not accept chemotherapy, for cohort 4, patients should fail with generation 3 and platinum-based chemotherapy.
. At least 1 measurable lesion per RECIST Version 1.1.
. Life expectancy ≥ 12 weeks.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
. Adequate organ and hematologic function
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse events incidence and severity
Timeframe: Up to approximately 60 months after the first participant was enrollment
2
Overall Response Rate（ORR）per RECST 1.1
Timeframe: Up to approximately 60 months after the first participant was enrollment
. Women with fertility tested negative for blood pregnancy within 7 days prior to trial screening; Any male or female patients with fertility must agree to use effective contraceptive methods throughout the entire trial period and within six months after the end of the trial.
. Patients must give informed consent to this study before the trial and voluntarily sign a written informed consent form.
Exclusion criteria
. Previously received EGFR monoclonal antibody therapy.
. Have received anti-tumor treatments such as chemotherapy, biological therapy, targeted therapy, immunotherapy, etc. within 4 weeks prior to the first use of the study drug.
. Have undergone major organ surgery (excluding biopsy) or experienced significant trauma within 4 weeks prior to the first use of the study drug.
. Have received other clinical study drugs within 4 weeks prior to the first use of the study drug.
. Known hypersensitivity or intolerance to any component of the study drug or its excipients.
. Those who use strong or moderate CYP3A4 inducers within 14 days before the first administration of the study drug.
. The adverse reactions of previous anti-tumor treatments have not yet recovered to CTCAE 5.0 evaluation ≤ level 1 except for toxicity such as alocepia, which is judged to be of no safety risk by researchers;
. Central nervous system metastasis or meningeal metastasis with clinical symptoms.