Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-26 @ 5:28 PM
Study NCT ID:
NCT04672759
Status:
UNKNOWN
Last Update Posted:
2020-12-17
First Post:
2020-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Real-world Study of Durvalumab for Lung Cancer in China
Sponsor:
Peking Union Medical College Hospital
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2020-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: