Study identifier:D5160C00048
ClinicalTrials.gov identifier:NCT03521154
EudraCT identifier:2018-001061-16
CTIS identifier:N/A
A Phase III, randomized, double-blind, placebo-controlled, multicenter, international study of osimertinib as maintenance therapy in patients with locally advanced, unresectable EGFR mutation-positive Non-Small Cell Lung Cancer (Stage III) whose disease has not progressed following definitive platinum-based chemoradiation therapy (LAURA).
Non Small Cell Lung Cancer (Stage III)
Phase 3
No
Osimertinib 80mg/40mg, Placebo Osimertinib 80mg/40mg
All
216
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jul 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Osimertinib Osimertinib (80mg or 40mg orally, once daily), in accordance with the randomization schedule. | Drug: Osimertinib 80mg/40mg The initial dose of Osimertinib 80mg once daily can be reduced to 40mg once daily. Treatment can continue until disease progression, unacceptable toxicity or other discontinuation criteria are met. |
Placebo Comparator: Placebo Osimertinib Matching placebo for Osimertinib (80mg or 40mg orally, once daily), in accordance with the randomization schedule | Drug: Placebo Osimertinib 80mg/40mg The initial dose of Placebo Osimertinib 80mg once daily can be reduced to 40mg once daily. Treatment can continue until disease progression, unacceptable toxicity or other discontinuation criteria are met |