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This is a prospective, one-arm, phase II study aimed at evaluating tislelizumab combined with platinum-containing dual-drug chemotherapy as a neoadjuvant treatment, supplemented with tislelizumab after surgery in patients with stage III non-small cell lung cancer.
The study included a screening period, a treatment period (including neoadjuvant treatment, surgery and postoperative adjuvant treatment), and a survival follow-up period.
Patients who meet the admission criteria will receive the following treatments according to disease stage (IIIA/IIIB) and histology (squamous or non-squamous) Tilelizumab + platinum-containing dual-agent chemotherapy, every 3 weeks as a cycle , for 2 cycles, followed by surgical resection, and postoperative adjuvant Tilelizumab + platinum-containing dual-agent chemotherapy 2cycles,every 3 weeks as a cycle, and Tilelizumab every 3 weeks up to 15cycles maintenance treatment.
The rate of radical resection (R0) was evaluated through the research center of the investigator, which is expected to be 20% higher compared with historical controls, and the effectiveness of tislelizumab combined with platinum-containing dual-drug chemotherapy as a neoadjuvant treatment was evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tilelizumab+Albumin Paclitaxel + Carboplatin/Cisplatin | Experimental | Tilelizumab 200mg d1 Albumin Paclitaxel 260mg/m2 d1 Carboplatin/Cisplatin 75mg/m2/AUC5 d1IV,Q3W *2cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tislelizumab | Drug | Tilelizumab 200mg d1 Q3W Albumin Paclitaxel 260mg/m2 d1 Carboplatin/Cisplatin 75mg/m2/AUC5 d1 every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of radical resection (R0) | In the intention-to-treat (ITT) analysis set, the rate of radical resection (R0) is evaluated by the investigator, which is the number of people who can undergo R0 resection after the evaluation criteria established by the MDT team divided by the total number of enrolled groups | 2 weeks after neoadvant |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | The investigator evaluated the 24-month PFS to evaluate tislelizumab combined with platinum-containing dual-drug chemotherapy as a neoadjuvant treatment, and tislelizumab was added as an adjuvant treatment | up to 24-month |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker level of PD-L1 | A PDL1 test measures the amount of PDL1 protein on cancer cells | 2 weeks after surgery |
| Biomarker count of CD8+T cell | 2 weeks after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| yongseng wang | West China Hospital | Principal Investigator |
| qinghua zhou | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University | Chengdu | Sichuan | 610041 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017672 |
| Nitrogen Compounds |
| D017671 | Platinum Compounds |