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Durvalumab in Stage II-III NSCLC Patients With Minimal Residual Disease
NCT04642469Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2020
- Primary completion
- May 2023
- Countries
- 25
- Sponsor
- AstraZeneca
- Modality
- Antibody Conjugates, Engineered Antibody Formats, PD-1/PD-L1 Inhibitors
- Drugs
- durvalumab
- Conditions
- non-small cell lung cancer (NSCLC)
01
Overview
Phase 3, randomised, double-blind trial in non-small cell lung cancer (NSCLC) comparing Durvalumab with Placebo (2 arms). Primary endpoint: Disease-free Survival up to 16.6 months. Started Nov 2020; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Durvalumab
Intravenous administration of Durvalumab
Placebo
Intravenous administration of placebo
03
Who it enrols
Patients with stage II-III NSCLC who have completed curative intent therapy (surgery +/- neoadjuvant/adjuvant), are MRD positive during surveillance, and have no RECIST recurrence. EGFR/ALK mutations are excluded.
04
Endpoints
Primary
Disease-free Survival
Secondary
Adverse Events
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