Lung Squamous Cell Carcinoma Stage IV
Conditions
Brief summary
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.
Interventions
Nivolumab or Pembrolizumab
Sponsors
Guangdong Association of Clinical Trials
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men and woman, aged over 18 2. Cytology or histologically confirmed squamous cell lung cancer 3. Advanced squamous cell lung cancer, Stage IIIb to IV according to AJCC staging (version 8) 4. Patients receiving approved PD-1 mAb in combination with chemotherapy according to their condition 5. Patients receiving PD-1 mAb in combination with chemotherapy for at least one cycle (21 days) 6. Have imaging results with measurable tumor 2 weeks before receiving PD-1 mAb in combination with chemotherapy 7. Able to understand and comply with the requirements of the consent and voluntarily participate in the study
Exclusion criteria
1. Patients participating in other clinical studies 2. Severe medical data missing 3. Unable to understand the purpose of the study or not agree with the requirement of the study 4. Malignancies other than squamous cell lung cancer, history of malignancies 5. Unsuitable for the study according to investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2 year survival rate | 2 years | — |
| objective response rate | 2 years | — |
| disease control rate | 2 years | free survival |
| median progression free survival | 2 years | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of adverse reactions | 2 years | Safety of the combination of PD-1 and chemotherapy |
Countries
China
Contacts
Primary ContactChongrui Xu
Outcome results
None listed