NCT06319313
Not yet recruiting
Phase 2
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
Shanghai JMT-Bio Inc.0 sites534 target enrollmentStarted: May 1, 2024Last updated:
ConditionsSquamous Cell Non-small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Shanghai JMT-Bio Inc.
- Enrollment
- 534
- Primary Endpoint
- Overall response rate (ORR)
Overview
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）.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Patients must give informed consent to this study before the experiment and voluntarily sign a written informed consent form.
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;
- •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;
- •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;
- •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;
Arms & Interventions
JMT101+ docetaxel
Experimental
Intervention: JMT101 (Drug)
JMT101+ docetaxel
Experimental
Intervention: docetaxel (Drug)
JMT101+HB1801
Experimental
Intervention: JMT101 (Drug)
JMT101+HB1801
Experimental
Intervention: HB1801 (Drug)
HB1801
Experimental
Intervention: HB1801 (Drug)
Outcomes
Primary Outcomes
Overall response rate (ORR)
Time Frame: Up to approximately 2 years
Overall Survival (OS)
Time Frame: Up to approximately 3 years
Incidence and severity of adverse events (AE) and serious adverse events (SAE)
Time Frame: Up to approximately 3 years
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
Secondary Outcomes
- Progression-free Survival (PFS)(Up to approximately 2 years)
- Disease Control Rate (DCR)(Up to approximately 2 years)
- Duration of response（DOR）(Up to approximately 2 years)
- JMT101 Concentrations in Plasma(Up to approximately 2 years)
- Total and Free Docetaxel Concentrations in Plasma(Up to approximately 2 years)
Investigators
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