A Real-world Study of Durvalumab for Lung Cancer in China
NCT04672759 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100
Last updated 2020-12-17
Summary
PACIFIC-PUMCH-R is an ambispective cohort study that will enroll approximately 100 patients with lung cancer who have received at least one dose of durvalumab between July 2020 and July 2021. Patient selection and data collection will be from Peking Union Medical College Hospital.
Cohort 1 will include patients with unresectable stage III non-small cell lung cancer (according to the Staging Manual in Thoracic Oncology, version 7, of the International Association for the Study of Lung Cancer) who did not have disease progression after concurrent chemoradiotherapy. The primary objective of Cohort 1 is to assess the effectiveness of durvalumab in a real-life setting by evaluating PFS and OS in Chinese patients.
Cohort 2 will enroll patients with histologically or cytologically confirmed NSCLC or SCLC who have received chemotherapy/radiotherapy at the physician's discretion. And this Cohort aimed to assess the safety of durvalumab for the treatment of lung cancer in clinical practice.
Conditions
- Non Small Cell Lung Cancer Stage III
- Small-Cell Lung Cancer
Interventions
- DRUG
-
Patients receive durvalumab as an intravenous infusion over 60 minutes on day 1. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
- DRUG
-
Durvalumab monotherapy or combined with chemotherapy and/or radiotherapy.
Sponsors & Collaborators
-
Peking Union Medical College Hospital
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-07-28
- Primary Completion
- 2021-06-30
- Completion
- 2024-10-31
Countries
- China
Study Locations
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