NCT04672759

A Real-world Study of Durvalumab for Lung Cancer in China

A Real-world Study of Consolidation Durvalumab for Stage III Unresectable Non-small Cell Lung Cancer in China and Safety Data on Durvalumab in Chinese Patients With Lung Cancer（PACIFIC-PUMCH-R）

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Durvalumab	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	Durvalumab monotherapy or combined with chemotherapy and/or radiotherapy.

Timeline

• Start date: 2020-07-28
• Primary completion: 2021-06-01
• Completion: 2024-10-01
• First posted: 2020-12-17
• Last updated: 2020-12-17

Locations

1 site across 1 country: China