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After receiving neoadjuvant treatment with PD-1 antibody and undergoing radical resection, a total 36 to 45 NSCLC patients who met the inclusion criteria, will be randomly assigned in a 1:1:1 ratio to the experimental group 1, experimental group 2 and the control group in this Phase IIa clinical trial. The study will be followed up until 24 to 36 months after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LM103 TILs +PD-1/PD-L1 monoclonal Group | Experimental |
| |
| LM103 TILs Group | Experimental |
| |
| Control Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LM103 TILs Injection | Biological | Extract, culture and expand tumor-infiltrating lymphocytes from resected tumor tissues in vitro for the manufactur of LM103 TILs injection. After NMA-LD, the subjects received LM103 infusion and followed by IL-2 supportive treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) | AEs will be recorded and assessed according to CTCAE Version 6.0 | Maximum 24~36 months |
| Disease Free Survival | Based on pathological diagnosis or imaging results | Every 12 weeks from treatment to 24~36 months |
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Inclusion Criteria:
At the date of signing Informed Consent Form (ICF), 18 ~75 years old, male or female;
Expected survival time >3 months;
ECOG performance status 0-1;
Pathologically diagnosed as resectable non-small cell lung cancer:
i. Driver gene mutations was negative; ii. No disease recurrence (including local recurrence) after surgery; iii. Expected to complete standard adjuvant therapy.
Patients have lesions that can be used for surgical resection or biopsy puncture;
Patients have sufficient hematology and organ functions;
Voluntarily sign a written informed consent form (ICF).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yilong Wu, Prof. Dr. Med | Contact | 86-20-83821484 | gzyilong@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yilong Wu | Guangdong Provincial People's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 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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| PD-1 / PD-L1 monoclonal antibody | Biological | Received PD-1 antibody treatment according to the instructions. |
|
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | China |
|
| Zhujiang Hospital of Southern Medical University | Not yet recruiting | Guangzhou | Guangdong | China |
|
| Henan Provincial People's Hospital | Recruiting | Zhengzhou | Henan | China |
|
| The Third People's Hospital of Chengdu | Not yet recruiting | Chengdu | Sichuan | China |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |