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Major objectives to evaluate the efficacy and safety of lparomlimab and Tuvonralimab Injection ((QL1706, an Anti-PD-1/CTLA-4 Combined Antibody)) combined with SBRT in patients with early-stage non-small cell lung cancer.
This single-arm, single-center clinical study aims to evaluate the efficacy and safety of lparomlimab and Tuvonralimab Injection ((QL1706, an Anti-PD-1/CTLA-4 Combined Antibody)) combined with SBRT in patients with early-stage non-small cell lung cancer. This study consists of three phases: screening, treatment, and follow-up.Efficacy evaluation and safety monitoring should be performed throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lparomlimab and Tuvonralimab Injection in Combination with SBRT | Experimental | lparomlimab and Tuvonralimab Injection in Combination with SBRT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lparomlimab and Tuvonralimab Injection in Combination with SBRT | Drug | lparomlimab and Tuvonralimab Injection: 5 mg/kg, administered every 3 weeks (q3w). The first dose should be given within one week after the initial SBRT fraction. The treatment duration is one year. SBRT: 50 Gy in 4 fractions or 70 Gy in 10 fractions, to be completed within 1-2 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year EFS | up to 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on investigator assessment. | up to 12 month |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ningbo Liu | Contact | 15822117210 | liuningbo@tjmuch.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhiyong Yuan | Tianjin Medical University Cancer Institute and Hospital | Principal Investigator |
| Ningbo Liu | Tianjin Medical University Cancer Institute and Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300000 | China |
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|
OS was defined as the time from the first dose of study drug to death due to any cause. |
| up to 36 month |
| Adverse Events | An AE was defined as any untoward medical occurrence in a pharmaceutical productwhich does not necessarily have to have a causal relationship with this treatment. | up to 36 month |
| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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