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This study aims to investigate the efficacy and safety of targeted therapy and chemotherapy±immunotherapy as neoadjuvant therapy in stage IIB-IIIB NSCLC patients.(observational study)
This is an open, observational clinical study, 2-3 cycles treatment will be planned as neo-adjuvant therapy for NSCLC participants in stage IIB-IIIB.
Study design:
Newly diagnosed Resectable IIB-IIIB NSCLC EGFR/ALK/ROS1 TEST PD-L1 TEST Collect puncture biopsy tissue/ Blood sample in screening period Chest enhanced CT Conditions allowed, whole body PETCT Exam; Group A:Targeted therapy Tumors with Driver genes (EGFR/ALK/ROS1 Positive) 2 cycles(42 days; Group B:Immunotherapy Enroll Patients from 816 Research treated with Neoadjuvant immunotherapy Or, treated with immunotherapy in practice(with approval) Group C:Routine Chemotherapy Driver genes(EGFR/ALK/ROS1 Negative) and PD-L1 Test negative or unknown; Operation (within 6 Ws postoperation) Standard treatment, Allow adjuvant chemotherapy±radio therapy Collect resected tissue sample(Tumor T and Node N) /Blood sample; comparisons before and after treatment: Imaging:CT、PET-CT Sample:Tumor tissue、blood
Objective and End point:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant immunotherapy | pd-1 or pd-l1 inhabitors |
| |
| Neoadjuvant targeted therapy | TKIs |
| |
| Neoadjuvant chemotherapy | chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-PD-1 or anti-PD-L1 | Drug | immunotherapy anti-PD-1 or anti-PD-L1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| DFS: disease free survival | The time length from randomization(mainly from the receipt of pathology and genetic diagnosis reports)to any of the following events: disease progression, disease recurrence or death from any cause. Disease progression or relapse will be assessed according to RECIST 1.1 | 36 months |
| pCR: pathologic complete response | the proportion of patients achieved pathologic complete response(lung and lymph node without tumor residual assessed by pathology review) | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| OS: Overall survival | The time length from the date of randomization (according to the received pathology and genetic diagnosis report) to the date of death. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| cRR rates | The proportion of patients achieved complete or patial remission(Imageological) according to RECIST 1.1 prior to definitive surgery | approximately 10 weeks After surgery |
| Safty AEs | proportion of delayed or cancelled surgery or duration of surgery or length of hospitalization or surgical procedure, and incidence of AE/SAE associated with surgery, Adverse events will be graded according to NCI CTCAE |
Inclusion Criteria:
Exclusion Criteria:
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NSCLC participants in stage IIB-IIIB(American Joint Committee on Cancer 8th edition criteria)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shun D Lu | Contact | 86-21-62821990 | 15216769608 | shunlu@sjtu.edu.cn |
| Yaxian Yao | Contact | 15216769608 | yaxianyao@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Shun Lu | Shanghai Chest Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Department, Shanghai Chest Hospital | Recruiting | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37655106 | Derived | Qi Y, Gu L, Shen J, Yao Y, Zhao Y, Lu S, Chen Z. An open, observational clinical study of neoadjuvant therapy in resectable stage III non-small cell lung cancer. Front Oncol. 2023 Aug 16;13:1194100. doi: 10.3389/fonc.2023.1194100. eCollection 2023. | |
| 36059450 | Derived | Gu L, Wang X, Sun Y, Xu Y, Niu X, Zhao R, Yao Y, Jian H, Han Y, Wei J, Chen Z, Lu S. An open, observational, three-arm clinical study of 2-3 cycles of treatment as neoadjuvant therapy in operable locally advanced non-small cell lung cancer: An interim analysis. Front Immunol. 2022 Aug 19;13:938269. doi: 10.3389/fimmu.2022.938269. eCollection 2022. |
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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 |
|---|---|
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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Subject's tumor sample obtained within 3 months before enrollment is suitable to be used for gene testing(EGFR/ALK/ROS1)and PD-L1 testing with Immunohistochemistry (IHC)。
| EGFR-TKI, ALK inhibitor, ROS1 inhibitor | Drug | targeted therapy EGFR-TKI, ALK inhibitor, ROS1 inhibitor |
|
|
| investigator decided | Drug | chemotherapy |
|
|
| 36 months |
| Qol Quality of Life | Quality of life asscesed by Quality of Life Questionnare-Core 30(EORTC QLQ-C30)of The European O-rganization for Reasearch and Treatment of Cancer containing 30 items in total. Among them, items 29 and 30 are divided into seven grades. According to the answer options 1 to 7 points. Other items are divided into four grades: none, one point, some to many. When scoring, they are directly rated 1 to 4 points. For functional and overal health domain, higher score means better life quality; for symptom domain ,higher score means worse life quality. | 36 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |