Study to Access Safety of Durvalumab in Indian Adult Patients With Locally Advanced NSCLC
- Sponsor
- AstraZeneca
- Study ID
- NCT04416633
- Phase
- PHASE4
- Status
- Completed
Conditions
- Unresectable Non-small Cell Lung Cancer (NSCLC)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Durvalumab — DRUG500-mg/120-mg IV
Study Details
A prospective, multicenter, Phase-IV clinical trial to assess safety of Durvalumab in Indian adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC)
Key Dates
- Start date
- Nov 30, 2021
- Status verified
- Aug 2024
- Primary completion
- Oct 27, 2023
- Completion
- Oct 27, 2023
Study Design
- Enrollment
- 100 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Other: DurvalumabSingle arm, Durvalumab , IV
Primary Outcome Measure
Number and Proportion of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) [ Time Frame: Evaluation Phase (Day 1 to 141) to Follow-up Phase (90 days after End of Evaluation Visit [Day 141]) ]