*ROSY-D
Research type
Research Study
Full title
Roll Over StudY for Patients Who Have Completed a Previous Oncology Study with Durvalumab and Are Judged by the Investigator to Clinically Benefit From Continued Treatment
IRAS ID
1004521
Contact name
Vaiva Smilgiute
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2021-003031-29
Clinicaltrials.gov Identifier
Research summary
We are doing this study to continue to provide participants with durvalumab to treat their cancer. This is the same durvalumab that they will have received when they recently took part in a study with durvalumab.
Durvalumab is approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of patients with locally advanced non-small cell lung cancer after chemoradiation therapy and extensive-stage small cell lung cancer in combination with chemotherapy.
As this study is about providing continued treatment with durvalumab for patients who were previously benefiting from treatment.
Participants in the study will have Durvalumab administered once every 4 weeks by the study staff using an intravenous (through veins) bag through an infusion that will last about 1 hour. Participants will be given a fixed dose of 1500 mg durvalumab. Participants will continue to receive durvalumab until they stop participating in the study or are no longer benefiting from the treatment.
Participants will have study visits every 4 weeks during which they will receive durvalumab until they stop the treatment. A safety follow up visit will be completed at 90 days after last dose of durvalumab.
There are no study specific procedures or tests that will be completed during the study. The study doctor will conduct routine safety assessments and evaluations to make sure participants are tolerating treatment with durvalumab.
There is no defined number of patients included in this sub-study. All patients from parent studies who are receiving durvalumab and who are eligible.REC name
London - Hampstead Research Ethics Committee
REC reference
22/FT/0002
Date of REC Opinion
16 Feb 2022
REC opinion
Further Information Favourable Opinion