NCT04306042

A Survival Observational Study in Patients With Advanced IIIB-IV Squamous Cell Lung Cancer Receiving PD-1 Combination With Chemotherapy

A Survival Observational Study in Patients With Advanced IIIB-IV Squamous Cell Lung Cancer Receiving PD-1 Combination With Chemotherapy (RESPONSE)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Guangdong Association of Clinical Trials · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Squamous Cell Carcinoma Stage IV

Interventions

Type	Name	Description
DRUG	Nivolumab or Pembrolizumab	Nivolumab or Pembrolizumab

Timeline

• Start date: 2020-03-01
• Primary completion: 2020-12-01
• Completion: 2022-12-01
• First posted: 2020-03-12
• Last updated: 2020-03-12

Locations

1 site across 1 country: China