Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a clinical study on the efficacy and safety of TQB2450 injection combined with chemotherapy or anlotinib hydrochloride capsule in the perioperative treatment of resectable non-small cell lung cancer. The part I study was planned to enroll 58 subjects, 1:1 randomized into two cohorts. The treatment regimen was as follows: Cohort 1: 3-4 cycles of TQB2450 combined with chemotherapy, surgery should be performed 4-6 weeks after the last administration, and TQB2450 therapy should be continued for 1 year after surgery. Cohort 2: 4 cycles of TQB2450 combined with 3 cycles of anlotinib hydrochloride capsule. Surgery was performed 4-6 weeks after the last dose and continued for 1 year starting 4 weeks after surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2450 injection + Chemotherapy | Experimental | TQB2450 injection combined with chemotherapy, 21 days as a treatment cycle. |
|
| TQB2450 injection + Anlotinib Hydrochloride Capsule | Experimental | TQB2450 injection combined with anlotinib hydrochloride capsule, 21 days as a treatment cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2450 injection + Chemotherapy | Drug | TQB2450 injection is a humanized monoclonal antibody targeting programmed death ligand -1 (PD-L1). Chemotherapy is a systematic treatment that kill fast growing cells. |
| Measure | Description | Time Frame |
|---|---|---|
| Major pathologic response (MPR) | MPR defined as the percentage of subjects with a residual surviving tumor less than or equal to 10% after surgery. | Baseline up to 60 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | From randomization to the time of death from any cause. | Baseline up to 60 months. |
| 2/3 year OS rate | The ratio of two-year survival to three-year survival. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shugeng Gao, Doctor | Contact | +86 13901362568 | 13901362568@139.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital of Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| TQB2450 injection + Anlotinib Hydrochloride Capsule | Drug | TQB2450 injection is a humanized monoclonal antibody targeting programmed death ligand -1 (PD-L1). Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor. |
|
| Baseline up to 36 months. |
| Event free survival (EFS) assessed by the investigator. | From the time of randomization to the occurrence of a predetermined event, including death, disease progression, change to chemotherapy, change to chemotherapy, addition of other treatments, occurrence of fatal or intolerable side effects, etc. | Baseline up to 60 months. |
| Disease free survival (DFS) assessed by Blinded Independent Central Review (BICR) | The time from randomization to the onset of tumor recurrence or death from any cause. | Baseline up to 60 months. |
| Pathological complete response (pCR) | Ratio of patients with no residual cancer cells found in the pathological examination after treatment. | Baseline up to 4 months. |
| R0 resection rate | The proportion of subjects who could undergo R0 resection, which is one of the surgery-related end points. | Baseline up to 4 months. |
| Surgical delay rate | The proportion of subjects who could not undergo surgery in time after neoadjuvant therapy. | Baseline up to 4 months. |
| Pathological downgrading rate | The proportion of patients with reduced lung cancer stage determined by pathological results after surgery. | Baseline up to 4 months. |
| Beijing Chaoyang Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100027 | China |
|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
|
| Beijing Chest Hospital, Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | 101149 | China |
|
| Fujian Medical University Union Hospital | Recruiting | Fuzhou | Fujian | 350001 | China |
|
| Weifang People's Hospital | Recruiting | Weifang | Shandong | 261044 | China |
|
| Shanghai Chest Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200030 | China |
|
| Shanxi Cancer Hospital | Recruiting | Taiyuan | Shanxi | 030013 | China |
|
| Tianjin Medical University General Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300070 | China |
|
| Tianjin Chest Hospital | Recruiting | Tianjin | Tianjin Municipality | 300222 | China |
|
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided