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This study uses a prospective cohort design.Subjects are randomly divided into three groups (A, B, C) before surgery. Group A gets 3 cycles of sintilimab + chemo, Group B gets 2 cycles + 1 cycle, and Group C gets 1 cycle + 2 cycles.
Non-squamous NSCLC subjects receive pemetrexed/albumin paclitaxel + platinum, while squamous NSCLC subjects get albumin paclitaxel + platinum.
This study adopts a prospective cohort study design.The subjects will be randomly divided into three groups according to the ratio of 1:1:1 prior to surgery: group A, group B and group C. The subjects in group A will receive 3 cycles of sintilimab plus platinum-based chemotherapy, group B will receive 2 cycles of sintilimab plus platinum-based chemotherapy plus 1 cycle of sintilimab, and group C will receive 1 cycle of sintilimab plus platinum-based chemotherapy plus 2 cycles of sintilimab. Non-squamous NSCLC subjects will receive pemetrexed/albumin paclitaxel and platinum (cisplatin/carboplatin), and squamous NSCLC subjects will receive albumin paclitaxel and platinum (cisplatin / carboplatin).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Experimental | receive 3 cycles of sintilimab plus platinum-based chemotherapy |
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| group B | Experimental | receive 2 cycles of sintilimab plus platinum-based chemotherapy plus 1 cycle of sintilimab |
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| group C | Experimental | receive 1 cycle of sintilimab plus platinum-based chemotherapy plus 2 cycles of sintilimab |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sintilimab plus platinum-based chemotherapy | Drug | The subjects in group A will receive 3 cycles of sintilimab plus platinum-based chemotherapy |
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| Measure | Description | Time Frame |
|---|---|---|
| pCR rate | rate of pathological complete response | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| MPR rate | rate of major pathologic response | 4 months |
| R0 resectability rate | R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed |
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Inclusion Criteria:
Exclusion Criteria:
1)Active infection ( requiring anti-infective drugs or systemic anti-infective drugs used within the previous week of randomization ) ; 2)congestive heart failure [New York Heart Association, NYHA ≥ grade II]; 3)Severe arrhythmia, liver, kidney, or metabolic disease requiring medical treatment; 4)Untreated coronary atherosclerotic heart disease; 5)Have a history of gastrointestinal perforation and / or fistula, a history of intestinal obstruction, extensive bowel resection or long-term chronic diarrhea within the previous 6 months.
20.Received solid organ or blood system transplantation
21.Have a history of HIV infection (HIV1/2 antibody positive), active syphilis
22.Tuberculosis, which is active or requires medical intervention at this stage, including but not limited to pulmonary tuberculosis
23.Active Hepatitis B Subjects with hepatitis B who met the following criteria met the inclusion criteria: HBsAg (+) or HBcAb (+), HBV viral load < 2000 copies/ml or < 200 IU/ml or lower than the detection limit HBsAg Subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-) do not need to receive prophylactic anti-HBV treatment, but need to closely monitor whether the virus is reactivated
24.Active hepatitis C (HCV antibody positive and HCV-RNA level above the detection limit)
25.Patients with malignant tumors other than confirmed NSCLC within the first 5 years of randomization, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, and thyroid papillary carcinoma after radical surgery
26.Sintilimab and/or selected chemotherapy regimens (non-squamous NSCLC : pemetrexed plus cisplatin or carboplatin ; squamous NSCLC : Albumin paclitaxel plus cisplatin or carboplatin) active ingredients and/or any excipients have allergic reactions
27.Pregnant or lactating women or women preparing to be pregnant or lactating during the study period
28.Subjects are mental illness or drug abuse that may have an impact on compliance with the test requirements, and have a history of alcohol abuse
29.Subjects with medical history, disease, treatment or laboratory abnormality which may interfere with the results of the trial, prevent the subject from participating in the study throughout the study, or the researchers believe that subjects in the study can not get the best interests of the subject Local or systemic diseases caused by non-malignant tumors, or secondary reactions to cancer, can lead to higher medical risks and/or uncertainty in survival evaluation.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaolong Yan | Contact | 8615991269383 | yanxiaolong@fmmu.edu.cn | |
| mingliang xing | Contact | 15129745755 | 312596733@QQ.COM |
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To protect patient privacy
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A Prospective Cohort Study
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| sintilimab plus platinum-based chemotherapy | Drug | The subjects in group B will receive 2 cycles of sintilimab plus platinum-based chemotherapy plus 1 cycle of sintilimab |
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| sintilimab plus platinum-based chemotherapy | Drug | The subjects in group C will receive 1 cycle of sintilimab plus platinum-based chemotherapy plus 2 cycles of sintilimab. |
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| 4 months |
| The completion rate of surgery on schedule | The rate of surgical completion as per the pre-established schedule represents a crucial metric in evaluating the efficiency and precision of medical institutions | 4 months |
| ID | Term |
|---|---|
| C000632826 | sintilimab |
| D017671 | Platinum Compounds |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
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