First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03798535|
Recruitment Status : Active, not recruiting
First Posted : January 10, 2019
Last Update Posted : January 22, 2021
This is a non-interventional/observational cohort of NSCLC unresectable stage III patients treated with durvalumab.
The study will be carried out as a retrospective review of established medical records for a subset of unresectable stage III patients treated with durvalumab.
|Condition or disease|
This is a non-interventional/observational study including NSCLC unresectable Stage III patients treated with durvalumab. Patient selection and retrospective data collection will be from participating countries: Australia, Belgium, Israel, Netherlands, Norway France, Germany, Italy, Switzerland, Spain
Chart abstractions will occur at specified intervals up to five years after the patient had the first dose of durvalumab. A target of four (maximum five) chart extractions is anticipated for each participant. Dates may be adjusted based on local market ethics processes or patient enrolment.
- First chart extraction will be used to determine which patients meet the inclusion/exclusion criteria for the study and will retrospectively collect all data from diagnosis of stage III unresectable NSCLC and the durvalumab start date (index date).
- The second chart extraction will be triggered at time of estimated maturity of PFS data to provide an accurate measure of the PFS outcome.
- The third chart extraction will be triggered at time of estimated maturity of OS data to provide an accurate measure of the OS outcome• The fourth and fifth chart extractions will occur approximately 3-years and 5-years after enrolment
- The dates for the second through fifth chart abstractions may be adjusted, pending data availability. The estimated PFS and OS maturity will be calculated from the actual patient index dates (date of first dose of durvalumab) and any available data on PFS and OS observed in the first extraction together with the distribution of PFS and OS observed in the PACIFIC trial.
|Study Type :||Observational|
|Actual Enrollment :||1194 participants|
|Official Title:||First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy|
|Actual Study Start Date :||December 19, 2018|
|Estimated Primary Completion Date :||December 20, 2023|
|Estimated Study Completion Date :||December 20, 2023|
- To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating progression free survival (PFS) [ Time Frame: PFS is assessed as PFS rates at 12 months and 18 months, and as PFS median for a period of time of 5 years. From Index date (first dose of durvalumab) to progression or death whichever came first, assessed up to 5 years. ]PFS defined as time from the index date (date of the first dose of durvalumab) to the date of investigator-determined disease progression or death (if no progression) or the end of follow-up
- To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating overall survival (OS) [ Time Frame: OS is assessed as OS rates at 2, 3 and 5 years, and as OS median for a period of time of 5 years. From Index date (first dose of durvalumab) to death or end of follow up, whichever came first, assessed during 5 years. ]OS following durvalumab regimen received from the index date to death or end of follow-up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03798535