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A total of 58 patients were enrolled in this exploratory study and randomly assigned to cohort 1 and cohort 2, with 29 patients in each group. Cohort 1: Neoadjuvant therapy (benmelstobart combined with anlotinib, 3 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1; anlotinib, 12 mg, po, qd, was taken orally for 2 consecutive weeks and stopped for 1 week. Anlotinib was stopped 1 week before surgery. Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Adjuvant therapy (benmelstobart combined with anlotinib, 12 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1; anlotinib, 12 mg, po, qd, was taken orally for 2 weeks and stopped for 1 week. Cohort 2: Neoadjuvant therapy (benmelstobart only, 3 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1. Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Adjuvant therapy (benmelstobart, 12 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Neoadjuvant therapy (benmelstobart combined with anlotinib) | Experimental | A total of 58 patients were enrolled in this exploratory study and randomly assigned to cohort 1 and cohort 2, with 29 patients in each group. Cohort 1: Neoadjuvant therapy (benmelstobart combined with anlotinib, 3 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1; anlotinib, 12 mg, po, qd, was taken orally for 2 consecutive weeks and stopped for 1 week. Anlotinib was stopped 1 week before surgery. Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Adjuvant therapy (benmelstobart combined with anlotinib, 12 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1; anlotinib, 12 mg, po, qd, was taken orally for 2 weeks and stopped for 1 week. |
|
| Cohort 2: Neoadjuvant therapy (benmelstobart only) | Experimental | Cohort 2: Neoadjuvant therapy (benmelstobart only, 3 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1. Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Adjuvant therapy (benmelstobart, 12 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cohort 1: Neoadjuvant therapy (benmelstobart combined with anlotinib) | Drug | Cohort 1: Neoadjuvant therapy (benmelstobart combined with anlotinib, 3 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1; anlotinib, 12 mg, po, qd, was taken orally for 2 consecutive weeks and stopped for 1 week. Anlotinib was stopped 1 week before surgery. Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Adjuvant therapy (benmelstobart combined with anlotinib, 12 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1; anlotinib, 12 mg, po, qd, was taken orally for 2 weeks and stopped for 1 week. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete pathological response (pCR) | Complete pathological response (pCR): defined as no residual tumor cells in postoperative tumor tissue specimens (including no tumor residue in lymph nodes), based on pathological response evaluation criteria] | 7 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Major pathologic response rate (MPR) | Major pathologic response rate (MPR) as assessed/estimated by the investigator, i.e. the proportion of residual surviving tumor cells in the tumor bed in the postoperative specimen ≤10% | 7 days after surgery |
| Objective response rate (ORR) |
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Inclusion Criteria:
The primary organ functions are normal and should meet the following criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhao jinbo zhao | Contact | 13909219296 | zhaojinbo@aliyun.com |
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|
| Cohort 2: Neoadjuvant therapy (benmelstobart only) | Drug | Cohort 2: Neoadjuvant therapy (benmelstobart only, 3 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1. Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Adjuvant therapy (benmelstobart, 12 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1. |
|
The proportion of patients who exhibit a partial response (PR) or complete response (CR) to treatment is defined as follows. |
| 7 days before surgery |
| event-free survival (EFS) | The event-free survival (EFS) is defined as the duration from randomization to the occurrence of any event, which includes disease progression, postoperative recurrence, discontinuation of treatment for any reason, or death. | up to 2 years |
| disease-free survival (DFS) | The disease-free survival period (DFS) refers to the duration from the initiation of randomization until either disease recurrence or death from any cause. | up to 2 years |
| R0 removal rate | Proportion of R0 level surgery performed. | postoperative 6 hours |
| overall survival (OS) | Overall survival (OS) refers to the duration from the initiation of randomization until death occurs for any reason. | up to 3 years |
| Treatment-related adverse events evaluated according to CTCAE v5.0 | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | up to 2 years |
| Surgical complications evaluated according to the Clavien-Dindo classification | Number of participants with surgical complications as assessed by Clavien-Dindo | up to 2 years |
| 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 |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
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