Efficacy and Safety of JMT101 Combined Wth Docetaxel / HB1801 in Patients With Squamous Cell Non-… (NCT06319313) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
Efficacy and Safety of JMT101 Combined Wth Docetaxel / HB1801 in Patients With Squamous Cell Non-Small Cell Lung Cancer
534 participantsStarted 2024-05-01
Plain-language summary
This study is a phase II/III, randomized, controlled, open-label, multi-center study with safety run-in to evaluate the efficacy and safety of JMT101 combined with docetaxel/ HB1801 in Patients with Squamous cell non-small cell lung cancer （sqNSCLC）.
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 ranged from 18 to 75 years old (inclusive), regardless of gender;
. Pathological diagnosis as sqNSCLC, with EGFR highly expressed, without other driver genes
. Tumor tissue available for central laboratory testing;
. Disease progression after prior anti PD-1/PD-L1 and platinum containing chemotherapy
. Measurable disease according to RECIST1.1;
. Eastern Cooperative Oncology Group (ECOG) score 0-1 points;
. Life expectancy ≥3 months
. Adequate main organs and bone marrow function.
Exclusion criteria
. Previously used anti EGFR, or docetaxel;
. Central nervous system metastasis or meningeal metastasis;
. Patients with high risk of bleeding due to tumor invasion of important arteries;
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
Overall response rate (ORR)
Timeframe: Up to approximately 2 years
2
Overall Survival (OS)
Timeframe: Up to approximately 3 years
3
Incidence and severity of adverse events (AE) and serious adverse events (SAE)
. Uncontrolled or requiring repeated drainage of pleural effusion, pericardial effusion, or abdominal effusion;
. The adverse reactions of previous anti-tumor treatments (including radiotherapy) have not yet recovered to CTCAE 5.0 evaluation ≤ level 1 except for toxicity such as alocepia or fatigue, which is judged to be of no safety risk by researchers;
. Diagnosed as a second primary malignant tumor (except for skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ and breast carcinoma in situ, etc.) within 5 years prior to the first administration of the study drug;
. Have received anti-tumor treatments such as systemic chemotherapy, biological therapy, immunotherapy, radical radiotherapy chemotherapy, etc. within 28 days before the first dose of the study drug;
. Have undergone major surgery (excluding needle biopsy) or suffered severe traumatic injury within 28 days before the first dose of study drug;