A Global Study to Assess the Effects of Osimertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer (LAURA)
Part of paid clinical trials in Duarte, California.
- Sponsor
- AstraZeneca
- Study ID
- NCT03521154
- Phase
- PHASE3
- Status
- Active Not Recruiting
Conditions
- Non Small Cell Lung Cancer (Stage III)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 130 Years
- Healthy Volunteers
- Not accepted
Interventions
- Osimertinib 80mg/40mg — DRUGThe 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 Osimertinib 80mg/40mg — DRUGThe 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
Study Details
A global study to assess the efficacy and safety of osimertinib following chemoradiation in patients with stage III unresectable Epidermal Growth Factor Receptor Mutation Positive non-small cell lung cancer
Key Dates
- Start date
- Jul 19, 2018
- Status verified
- Apr 2026
- Primary completion
- Jan 5, 2024
- Completion
- Oct 29, 2027
Study Design
- Enrollment
- 216 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: OsimertinibOsimertinib (80mg or 40mg orally, once daily), in accordance with the randomization schedule.
- Placebo Comparator: Placebo OsimertinibMatching placebo for Osimertinib (80mg or 40mg orally, once daily), in accordance with the randomization schedule
Primary Outcome Measure
Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) [ Time Frame: Every 8 weeks for first 48 weeks, then every 12 weeks until BICR-confirmed radiological disease progression. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months ]
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Research Site | Duarte | California | 91010 | - |
| Research Site | Atlanta | Georgia | 30322 | - |
| Research Site | Florham Park | New Jersey | 07932 | - |
| Research Site | Salt Lake City | Utah | 84106 | - |
| Research Site | Madison | Wisconsin | 53792 | - |
Related coverage on Hipa.ai
- Osimertinib Extends PFS to 39.13 Months in Stage III Unresectable NSCLCOsimertinib · Apr 3, 2025 · ClinicalTrials.gov