Clinical trial NCT06319313: Efficacy and Safety of JMT101 Combined Wth Docetaxel / HB1801 in Patients With Squamous Cell Non-Small Cell Lung Cancer
Official title: A Randomized, Controlled, Open-label Phase II/III Study of The Safety, Tolerability and Efficacy of JMT101 Combined With Docetaxel / HB1801 in Patients With sqNSCLC
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Squamous Cell Non-small Cell Lung Cancer
Lead sponsor: Shanghai JMT-Bio Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-20
Enrollment: 534
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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）.


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.

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: Up to approximately 2 years
measure: Overall Survival (OS)
timeFrame: Up to approximately 3 years
measure: Incidence and severity of adverse events (AE) and serious adverse events (SAE)
timeFrame: Up to approximately 3 years
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Up to approximately 2 years
measure: Disease Control Rate (DCR)
timeFrame: Up to approximately 2 years
measure: Duration of response（DOR）
timeFrame: Up to approximately 2 years
measure: JMT101 Concentrations in Plasma
timeFrame: Up to approximately 2 years
measure: Total and Free Docetaxel Concentrations in Plasma
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Sun Yat-sen University
name: Li Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: