A Global Study to Assess the Effects of Osimertinib Following Chemoradiation in Patients With Sta… (NCT03521154) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Global Study to Assess the Effects of Osimertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer (LAURA)
United States216 participantsStarted 2018-07-19
Plain-language 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
Who can participate
Age range18 Years – 130 Years
SexALL
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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.
Exclusion criteria
✕. Mixed small cell and non-small cell lung cancer histology
✕. History of interstitial lung disease (ILD) prior to chemoradiation
What they're measuring
1
Progression-free Survival (PFS) by Blinded Independent Central Review (BICR)
Timeframe: 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
✕. 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:
✕. 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).