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This is a prospective, observational, multicenter real-world study aiming to investigate the efficacy and safety of NSCLC patients with or without adjuvant immunotherapy who have achieved pathologic complete remission after neoadjuvant immunotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjuvant immunotherapy |
| ||
| Observational |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunotherapy | Drug | Monotherapy with PD-1 inhibitors, up to 1 year. |
|
| Measure | Description | Time Frame |
|---|---|---|
| DFS (Disease-Free Survival) | Evaluated by investigator based on RECIST1.1 | Approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year DFS (disease-free survival) rate | Evaluated by investigator based on RECIST1.1 | Approximately 3 years |
| OS (Overall Survival) | Evaluated by investigator based on RECIST1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with resectable non-small cell lung cancer (NSCLC) who have received immune checkpoint inhibitor neoadjuvant therapy and achieved pathological complete response (pCR).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital, Central South University Affiliated | Changsha | Hunan | 410008 | China |
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| Approximately 3 years |
| Recurrence and Metastasis Pattern | Approximately 3 years |
| AE (Adverse Event) | An AE is any untoward medical occurrence in a patient or clinical investigation participant administered an investigational product. Safety and tolerance evaluated by incidence, severity and outcomes of AEs (according to NCICTCAE 5.0) | Approximately 3 years |
| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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