Roll Over StudY for Patients Who Have Completed & Benefitted from a Previous Oncology Study With Durvalumab (ROSY-D)

ROSY-D: 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 - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061411

Enrollment

201

Registered

2024-01-12

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung

Interventions

Intervention1: Durvalumab: Fixed dose of 1500 mg via IV infusion upon enrollment visit and every 4 weeks thereafter Control Intervention1: Not Applicable: Not Applicable

Eligibility

Inclusion criteria

Inclusion criteria: The Core Protocol inclusion criteria are: Provision of signed and dated, written Informed Consent Form (ICF). Patient is currently deriving clinical benefit, as judged by the investigator, from continued treatment in an AstraZeneca parent study using an AstraZeneca compound that has met its endpoints, or has otherwise stopped, or the patient has reached maximum treatment duration allowed in the parent studys protocol. There are no additional inclusion criteria for the ROSY-D sub-study

Exclusion criteria

Exclusion criteria: Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study. Currently receiving treatment with any prohibited medication(s). Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Permanent discontinuation from the parent study due to toxicity or disease progression. Local access to commercially-available drug at no cost to the patient as permitted by local or country regulation. The additional exclusion criteria for the ROSY-D sub-study are: Active infection including Coronavirus disease 2019 (Polymerase chain reaction confirmed and or clinically suspected), tuberculosis, hepatitis B (known positive Hepatitis B virus (HBV) surface antigen result), hepatitis C, or Human immunodeficiency virus (HIV) (positive HIV 1 by 2 antibodies). Male or female patients of reproductive potential who are not willing to employ effective birth control from study inclusion up to 90 days after the last dose of durvalumab monotherapy. Ongoing, unresolved, Grade 2 toxicity with an inability to reduce corticosteroid to a dose of less than or equal to 10 mg of prednisone per day (or equivalent) within 12 weeks after last dose of study treatment or study regimen, per Toxicity Dose Modification and TMGs for Immune- mediated, Infusion-related, and Non-Immune-mediated Reactions Guidelines of the parent study.

Design outcomes

Primary

Measure	Time frame
To provide continuous study treatment to patients who continue to benefit at the end of a clinical study, while monitoring safety and tolerabilityTimepoint: SAEs reported until 90 days after the last dose of study treatment	—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

Argentina, Australia, Brazil, Bulgaria, Canada, China, Czech Republic, France, Germany, Hungary, India, Italy, Japan, Malaysia, Poland, Republic of Korea, Romania, Russian Federation, Singapore, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States of America, Viet Nam

Contacts

Public ContactDr Annappa Kamath

PAREXEL International Clinical Research Private Limited

Annappa.Kamath@parexel.com919902096914

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026