A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCL… (NCT05120349) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection
United States390 participantsStarted 2022-02-21
Plain-language summary
This is a global study to assess the effects of osimertinib in participants with EGFRm stage IA2-IA3 non-small cell lung cancer following complete tumour resection.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female, at least ≥ 18 years.
✓. NSCLC, of non-squamous histology.
✓. Stage IA2 or IA3 disease, based on TNM8 classification.
✓. Complete surgical resection (R0) of the primary NSCLC by lobectomy, bilobectomy, segmentectomy or sleeve resection.
✓. Complete recovery from surgery at the time of randomisation. Study intervention cannot commence within 4 weeks following surgery. No more than 12 weeks may have elapsed between surgery and randomisation for participants.
✓. World Health Organization performance status of 0 or 1.
✓. Provision of tumour sample for central pathology assessment of pathologic risk factors and to assess EGFR mutation status prior to randomisation.
✓. A tumour which harbours one of the 2 EGFR mutations (Ex19del, L858R) by cobas® EGFR Mutation Test v2 (Roche Diagnostics) or FoundationOne® test.
Exclusion criteria
✕. Mixed small cell and non-small cell cancer history.
✕. Participants with incomplete (R1/R2) resection, or who have undergone pneumonectomy or only wedge resection.
✕. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including HCV and HIV or active uncontrolled HBV infection.
What they're measuring
1
Disease-Free Survival (DFS) in high-risk stratum
Timeframe: From date of randomisation up to approximately 10 years
. History of another primary malignancy, including any known or suspected synchronous primary lung cancer except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention and of low potential risk for recurrence.
✕. Any of the following cardiac criteria:
✕. History of interstitial lung disease.
✕. Inadequate bone marrow reserve or organ function.
✕. Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study intervention.