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Trial Title:
Efficacy and Safety of JMT101 Combined Wth Docetaxel / HB1801 in Patients With Squamous Cell Non-Small Cell Lung Cancer
NCT ID:
NCT06319313
Condition:
Squamous Cell Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Docetaxel
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JMT101
Description:
JMT101, 6 mg/kg, IV infusion once every 2 weeks (one treatment cycle is 4 weeks). or 9
mg/kg, IV infusion once every 3 weeks.
Arm group label:
JMT101+ docetaxel
Arm group label:
JMT101+HB1801
Intervention type:
Drug
Intervention name:
docetaxel
Description:
50 mg/m2, IV infusion once every 2 weeks (one treatment cycle is 4 weeks). Or 75 mg/m2,
IV infusion once every 3 weeks.
Arm group label:
JMT101+ docetaxel
Intervention type:
Drug
Intervention name:
HB1801
Description:
75 mg/m2, IV infusion once every 2 weeks (one treatment cycle is 4 weeks). Or 100 mg/m2,
IV infusion once every 3 weeks.
Arm group label:
HB1801
Arm group label:
JMT101+HB1801
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）.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ranged from 18 to 75 years old (inclusive), regardless of gender;
2. Pathological diagnosis as sqNSCLC, with EGFR highly expressed, without other driver
genes
3. Tumor tissue available for central laboratory testing;
4. Disease progression after prior anti PD-1/PD-L1 and platinum containing chemotherapy
5. Measurable disease according to RECIST1.1;
6. Eastern Cooperative Oncology Group (ECOG) score 0-1 points;
7. Life expectancy ≥3 months
8. Adequate main organs and bone marrow function.
9. Patients must give informed consent to this study before the experiment and
voluntarily sign a written informed consent form.
Exclusion Criteria:
1. Previously used anti EGFR, or docetaxel;
2. Central nervous system metastasis or meningeal metastasis;
3. Patients with high risk of bleeding due to tumor invasion of important arteries;
4. Uncontrolled or requiring repeated drainage of pleural effusion, pericardial
effusion, or abdominal effusion;
5. 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;
6. 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;
7. 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;
8. Have undergone major surgery (excluding needle biopsy) or suffered severe traumatic
injury within 28 days before the first dose of study drug;
9. Have received a live viral vaccine or live-attenuated vaccine within 28 days before
the first dose of study drug or plan to receive it during the study;
10. Have received palliative radiotherapy, small molecule targeted therapy,
immunomodulatory drugs, NMPA approved modern traditional Chinese medicine
preparations and other anti-tumor treatments, within 14 days before the first dose
of study drug;
11. Those who use strong CYP3A4 inducers within 14 days before the first administration
of the study drug, or those who use strong CYP3A4 inhibitors within 1 week, or those
who cannot suspend the use of the above drugs during the study;
12. Have a history of serious cardiovascular disease;
13. Have a history of serious lung disease;
14. History of autoimmune diseases;
15. History of immunodeficiency
16. A history of gastrointestinal perforation and/or fistula within 6 months, or
gastrointestinal obstruction and active inflammatory bowel disease within 28 days
prior to the first study drug administration
17. Have infectious diseases requiring systemic anti-infective treatment;
18. Active hepatitis B; hepatitis C infection; syphilis infection, active tuberculosis;
19. Known hypersensitivity or intolerance to any component of EGFR monoclonal antibody,
human serum albumin, docetaxel, and its excipients; Individuals known to be allergic
and/or contraindicated to glucocorticoids
20. Women during lactation or pregnancy;
21. Any male and female patients with fertility who refuse to use effective
contraceptive methods throughout the entire trial period and within six months after
the last administration;
22. Other conditions that, in the opinion of the investigator, may affect the safety or
compliance of drug treatment in this study, including but not limited to:
psychiatric disorders, any severe or uncontrollable diseases, etc.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
May 1, 2024
Completion date:
December 1, 2027
Lead sponsor:
Agency:
Shanghai JMT-Bio Inc.
Agency class:
Industry
Source:
Shanghai JMT-Bio Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06319313
