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This is a multi-center, open-label, non-interventional, retrospective registry study, with no pre-set statistical assumptions and will not intervene subject's clinical treatment or clinical management.
In the study, the clinical data of the subjects will be retrospectively collected from the electronic health records (EHR) of each research center. The clinical information will be based on the actual medical records of the cases. After the retrospective study time (June 30, 2020), patients will be followed for one-year and two-year survival. Clinical treatment and management will be based on local clinical practices and regulations. This study will record the actual diagnosis and treatment, and will not interfere with any clinical decision.
After subject-out, patients will be followed for one-year and two-year survivals, thus the follow-up consent will be exempted. All patients receiving PD-1 monoclonal antibody in combination with chemotherapy will be visited during the entire study period. At the end of study, investigator will check up on the conditions of patients who withdraw from the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Patients diagnosed with primary stage IIIB-IV squamous cell lung cancer and treated in 92 medical centers between 01 September 2019 and 30 June 2020 will be targeted for study inclusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab or Pembrolizumab | Drug | Nivolumab or Pembrolizumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2 year survival rate | 2 years | |
| objective response rate | 2 years | |
| disease control rate | free survival | 2 years |
| median progression free survival | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of adverse reactions | Safety of the combination of PD-1 and chemotherapy | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with primary stage IIIB-IV squamous cell lung cancer and treated in 92 medical centers.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chongrui Xu | Contact | 86-20-838278812 | 50816 | xucr001@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | 510080 | China |
Patients information without identification data will be shared within centers enrolled in the study to perform the data analysis.
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| C582435 | pembrolizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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