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A Global Study to Assess the Effects of Osimertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer (LAURA)

NCT03521154 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2026-05-05

Study results available
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Summary

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

Conditions

  • Non Small Cell Lung Cancer (Stage III)

Interventions

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.

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

Sponsors & Collaborators

Principal Investigators

  • Suresh S Ramalingam, MD · Emory University School of Medicine, Atlanta, U.S.

  • Shun Lu, MD · Shanghai Chest Hospital, Shanghai, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-19
Primary Completion
2024-01-05
Completion
2027-10-29
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • China
  • Hungary
  • India
  • Japan
  • Malaysia
  • Mexico
  • Peru
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Vietnam

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03521154 on ClinicalTrials.gov