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

  • STATUS
    Recruiting
  • End date
    Jun 29, 2026
  • participants needed
    200
  • sponsor
    AstraZeneca
Updated on 11 July 2021
Investigator
AstraZeneca Clinical Study Information Center
Primary Contact
Research Site (0.0 mi away) Contact
+153 other location
growth factor
epidermal growth factor receptor
EGFR
cancer chemotherapy
epidermal growth factor
osimertinib
lung carcinoma

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

Description

This is a phase 3 double-blind, randomized, placebo-controlled, study to assess the efficacy and safety of osimertinib following chemoradiation in patients with stage III unresectable EGFR mutation-positive NSCLC, including the most common EGFR sensitising mutations (Ex19Del and L858R), either alone or in combination with other EGFR mutations. Chemoradiation may have been given either given concurrently or sequentially. Patients whose disease has not progressed following chemoradiation will be randomised within 6 weeks of completion of chemoradiation to receive osimertinib or placebo in a 2:1 ratio, and treatment will be continued until disease progression, unacceptable toxicity or other discontinuation criteria are met. After progression, patients can be unblinded and may receive open-label osimertinib. After the final OS analysis, the study blind will be broken and patients still receiving open-label osimertinib will be supplied with open-label osimertinib by AstraZeneca for as long as their treating physician considers they are deriving clinical benefit.

Details
Condition Non-Small Cell Lung Cancer, nsclc
Treatment Osimertinib 80mg/40mg, Placebo Osimertinib 80mg/40mg
Clinical Study IdentifierNCT03521154
SponsorAstraZeneca
Last Modified on11 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female aged at least 18 years
Patients with histologically documented NSCLC of predominantly non-squamous Pathology who present with locally advanced, unresectable (Stage III) disease (according to Version 8 of the International Association for the Study of Lung Cancer [IASLC] Staging Manual in Thoracic Oncology)
The tumor harbours one of the two common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations, assessed by cobas EGFR Mutation Test v2 (Roche Diagnostics) or FoundationOne test in a CLIA certified (USA sites) or an accredited local laboratory (sites outside of the USA) or by central testing (cobas v2 only)
Patients must have received either concurrent chemoradiation or sequential chemoradiation including at least 2 cycles of platinum based chemotherapy and a total dose of radiation of 60 Gy 10% (54 to 66 Gy)
Chemoradiation must be completed 6 weeks prior to randomization
Patients must not have had disease progression during or following definitive platinum-based, chemoradiation therapy
World Health Organization (WHO) performance status of 0 or 1
Life expectancy >12 weeks at Day 1
Female patients who are not abstinent (in line with the preferred and usual lifestyle choice) must be using adequate contraceptive measures, must not be breast feeding, and must have a negative pregnancy test prior to first dose of study drug; or female patients must have an evidence of non-childbearing potential

Exclusion Criteria

Mixed small cell and non-small cell lung cancer histology
History of interstitial lung disease (ILD) prior to chemoradiation
Symptomatic pneumonitis following chemoradiation
Any unresolved toxicity Common Terminology Criteria for Adverse Events (CTCAE) > Grade 2 from the prior chemoradiation therapy
Any of the following cardiac criteria
Mean resting corrected QT interval (QTc) >470 msec, obtained from 3 ECGs
Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG
Patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval and cause Torsades de Pointes
Inadequate bone marrow reserve or organ function
History of other malignancies, except: adequately treated non-melanoma skin cancer or lentigo maligna , curatively treated in-situ cancer, or other solid tumors curatively treated with no evidence of disease for > 5 years following the end of treatment and which, in the opinion of the treating physician, do not have a substantial risk of recurrence of the prior malignancy
Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib
Prior treatment with any prior chemotherapy, radiation therapy, immunotherapy or investigational agents for NSCLC outside of that received in the definitive setting for Stage III disease (chemotherapy and radiotherapy in SCRT and CCRT regimens is allowed for treatment of Stage III disease)
Prior treatment with EGFR-TKI therapy
Major surgery as defined by the investigator within 4 weeks of the first dose of study drug
Patients currently receiving (unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4 (at least 3 weeks prior to receiving the first dose of study drug)
Contraindication to MRI, including but not limited to, claustrophobia, pace makers, metal implants, intracranial surgical clips and metal foreign bodies
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