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The aim of this observational study is to investigate the treatment trajectory of immunotherapy in patients with squamous non-small cell lung cancer (sq-NSCLC). The primary objective is to identify potential indicators that can predict the efficacy of immunotherapy and explore strategies to prolong its effectiveness in sq-NSCLC patients. Biological specimens and medical imaging data will be collected from patients already receiving immunotherapy as a first-line treatment, and follow-up will be conducted to analyze prognosis based on different patterns.
The medical imaging data will be collected retrospectively and prospectively and the blood samples and tumor tissues will be collected prospectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| untreated sq-NSCLC patients | Patients diagnosed with sq-NSCLC for the first time |
| |
| sq-NSCLC patients treated with immunotherapy for -2-3 cycles | sq-NSCLC patients treated with immunotherapy combined with or without chemotherapy as first-line treatment for 2-3 cycles. |
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| sq-NSCLC patients receiving immunotherapy with poor efficacy | sq-NSCLC patients treated with immunotherapy combined with or without chemotherapy as first-line treatment and experience disease progression within six months. |
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| sq-NSCLC patients receiving immunotherapy with good efficacy | sq-NSCLC patients treated with immunotherapy combined with or without chemotherapy as first-line treatment and having progression-free survival longer than six months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efficacy observation | Other | Observation about the efficacy of sq-NSCLC patients receiving immunotherapy combined with or without chemotherapy as first-line treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | The time of disease progression is evaluated according to the Response Evaluation Criteria in Solid Tumors, version 1.1. | A two-year period after starting treatment (Regular follow-up every three months after receiving immunotherapy combined with or without chemotherapy as first-line treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The survival time aftering receiving immunotherapy combined with or without chemotherapy as first-line treatment. | A three-year period after starting treatment (Regular follow-up every six months after receiving immunotherapy combined with or without chemotherapy as first-line treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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From January 2021 to December 2025, about 1000 patients with sq-NSCLC receiving immunotherapy combined with or without chemotherapy as first-line treatment will be enrolled in this cohort study.
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| Name | Affiliation | Role |
|---|---|---|
| Xueyun Tan, MD | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Study Director |
| Yang Jin, PHD | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital, Tongji Medical college, Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
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Blood samples and tumor tissues will be retained.