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This study is a randomized, controlled, open-label, prospective, single-center phase II clinical study. Target population is patients with stage II and IIIA resectable non-small cell lung cancer who had not received systemic chemotherapy. Study objective is to evaluate the major pathologic response of SHR-1210 + carboplatin + paclitaxel-albumin in subjects with resectable non-small cell lung cancer. SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.
In this study, eligible subject will be randomized into study arm or control arm to accept study treatment. Subjects who randomized into control will have the opportunity to receive the treatment of carboplatin + paclitaxel-albumin therapy after confirmed disease progression. Treatment cycles of chemotherapy will be 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1210+Carboplatin+Paclitaxel-albumin | Experimental | Subject will receive SHR-1210 200mg every 3 weeks, carboplatin AUC 5 on Day 1 of each 21 day, Paclitaxel-albumin 130mg/m2 on Day 1 and Day 8 of each 21 day, 2 cycles. |
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| Carboplatin+Paclitaxel-albumin | Active Comparator | Subject will receive carboplatin AUC 5 on Day 1 of each 21 day, Paclitaxel-albumin 130mg/m2 on Day 1 and Day 8 of each 21 day, 2 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1210 | Drug | In the experimental group, 200mg SHR-1210 was given in the first day of each cycle, Carboplatin was given in the first day of each cycle, Paclitaxel-albumin was given in the first and eighth day of each cycle, with intravenous drip. |
| Measure | Description | Time Frame |
|---|---|---|
| Major pathologic response | It is defined as residual tumors less than 10% after neoadjuvant chemotherapy. | 3.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | It is defined as the proportion of patients whose tumors shrink to a predetermined size and maintain a minimum time limit. It includes the cases of CR and PR. | 6.5 months |
| Pathological complete response |
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Inclusion Criteria:
(1)Blood routine examination should be complied with (No blood transfusion, no use of hematopoietic factors and no use of drugs for correction within 14 days):
a.ANC ≥ 1.5×109/L; b.HB ≥ 90 g/L; c.PLT ≥ 100×109/L;
(2)Biochemical tests must meet the following criteria:
TBIL ≤ 1.5ULN;
ALT、AST≤ 2.5 ULN (If abnormal liver function is caused by liver metastasis, ALT、AST< 5ULN;
sCr≤1.5ULN,endogenous creatinine clearance rate≥50ml/min(Cockcroft-Gault formula);
(3)Blood coagulation must meet the following criteria: INR≤1.5 and APTT≤1.5 ULN;
10.Women of childbearing age must undergo a serological pregnancy test within 3 days before the first dose with negative results and willing to use a medically approved and effective contraceptive method (e.g. intrauterine device, contraceptive pill or condom) during the study and within three months after the last dose. For male subjects whose partners are women of childbearing age, they should be sterilized surgically or agree to use effective contraceptive methods during the study and within three months after the last dose.
11.Subjects should be voluntarily participate in clinical studies and informed consent should be signed.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuyang Yao | Contact | 15810401496 | yaoshuyang@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Zhang, Doctor | Xuanwu Hospital, Beijing | Principal Investigator |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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| Carboplatin and Paclitaxel-albumin | Drug | In the control group, Carboplatin was given in the first day of each cycle, Paclitaxel-albumin was given in the first and eighth day of each cycle, with intravenous drip. |
|
No histologic evidence of malignancy or only the ingredients of carcinoma in situ was found in primary tumors.
| 3.5 months |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |