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This is a randomized, open-label study designed to evaluate the safety and efficacy of neoadjuvant PD-1 antibody plus chemotherapy followed by surgery in resectable stage IIIA non-small cell lung cancer.
The primary endpoint: pCR rate The second endpoint: MPR, DFS, MRD
This study is a prospective, multicenter, phase III randomized controlled clinical study. Stage IIIA NSCLC patients with EGFR mutation negative and ALK rearrangement negative were enrolled, and after 2 courses of treatment with Sintilimab combined with Platinum-based Chemotherapy, they were randomly assigned 1:1 to the control group (surgical resection and postoperative treatment for 2 courses are recommended) or the experimental group (surgery after 2 courses of treatment).
The primary endpoint is pCR rate. The second endpoints are MPR, DFS, and MRD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Neoadjuvant therapy of Sintilimab and chemotherapy in 2 cycles before surgery and optional adjuvant therapy of Sintilimab and chemotherapy in 2 cycles after surgery |
|
| Experimental group | Experimental | Neoadjuvant therapy of Sintilimab and chemotherapy in 4 cycles before surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 and chemotherapy | Drug | Sintilimab+(Squamous)ABX+DDP/CBP, or (non-Squamous)PEM+DDP/CBP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathologically complete response (pCR) rate | in three weeks after the surgical resection |
| Measure | Description | Time Frame |
|---|---|---|
| Major pathological response (MPR) rate | in three weeks after the surgical resection | |
| Disease-free survival (DFS) | one, two, three and five years since the initial treatment (each treatment is 2 days) |
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Inclusion Criteria:
Resectable stage IIIA NSCLC, EGFR mutation-negative and ALK rearrangement negative (8th UICC TNM staging);
No prior anti-tumor therapy for NSCLC;
Age from 18 to 75 years old;
Adequate organ function:
Hemoglobin ≥9.0g/L; White blood cell count 4.0~10×109/L; The absolute value of neutrophils (ANC) ≥ 1.5×109/L; Platelet count ≥100×109/L; Total bilirubin ≤ 1.5 times the upper limit of normal; ALT and AST≤2.5 times the upper limit of normal; The international normalized ratio of prothrombin time is ≤1.5 times the upper limit of normal value, and the partial thromboplastin time is within the range of normal value; Creatinine ≤ 1.5 times the upper limit of normal;
No chemotherapy, radiotherapy or hormone therapy for malignant tumors, no history of other malignant tumors, excluding patients who have received hormone therapy for prostate cancer and have had DFS for more than 5 years;
ECOG 0~1;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiang Fan, MD | Contact | 15901013210 | fan_jiang@tongji.edu.cn | |
| Dong Lin, MD | Contact | 18121299433 | dlin2014@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiang Fan, MD | Shanghai General Hospital; Shanghai Pulmonary Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Recruiting | Shanghai | Shanghai Municipality | 200080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40777124 | Derived | Lin D, Wu L, Wang P, Li X, Wang X, Cai Y, Xiong K, Chen X, Yang F, Huang W, Wang X, Fan J. Dynamic circulating tumor DNA indicates pathological benefits of additional neoadjuvant chemoimmunotherapy courses for locally advanced non-small-cell lung cancer patients. Front Oncol. 2025 Jul 24;15:1563315. doi: 10.3389/fonc.2025.1563315. eCollection 2025. |
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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 |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Minimal residual disease(MRD) | in one week before each cycle and in the forth week after the surgical resection (each cycle is 21 days) |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |