A Study of 5 Years of Adjuvant Osimertinib in Completely Resected Epidermal Growth Factor Recepto… (NCT05526755) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of 5 Years of Adjuvant Osimertinib in Completely Resected Epidermal Growth Factor Receptor Mutation (EGFRm) Non-small Cell Lung Carcinoma (NSCLC)
United States, Hong Kong188 participantsStarted 2023-03-06
Plain-language summary
To assess the efficacy and safety of osimertinib in participants with EGFRm positive stage II-IIIB NSCLC, following complete tumour resection with or without adjuvant chemotherapy.
Who can participate
Age range18 Years – 130 Years
SexALL
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Inclusion criteria
✓. Male or female aged at least 18 years.
✓. Histologically confirmed diagnosis of primary NSCLC on predominantly non-squamous histology.
✓. Magnetic Resonance Imaging (MRI) or contrast computed tomography (CT) scan of the brain.
✓. Participants must be classified post-operatively as Stage II, IIIA, or IIIB on the basis of surgical pathologic criteria.
✓. Confirmation by the local laboratory that the tumour harbours one of the two common EGFR mutations (Ex19del, L858R), either alone or in combination with other EGFR mutations including de novo EGFR mutation resulting in substitution of threonine with methionine at amino acid position 790 in exon 20 of EGFR (T790M) or uncommon EGFR mutations G719X, S768I, and L861Q, either alone, in combination with each other, or in combination with other uncommon EGFR mutations (excluding all exon 20 insertions) (Uncommon EGFRm Cohort).
✓. Complete surgical resection of the primary NSCLC is mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumour.
✓. Complete recovery from surgery and standard post-operative therapy (if applicable) at start of study intervention.
✓. World Health Organisation Performance Status of 0 to 1.
Exclusion criteria
✕. Major surgery (including primary tumour surgery, excluding placement of vascular access) within 4 weeks prior to the first dose of study drug.
✕
What they're measuring
1
Estimate the Efficacy of Osimertinib as Measured by Disease Free Survival (DFS) [Common EGFRm Cohort].
Timeframe: From date of first dose until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 5 years. Assessed at 5 years.
. Participants currently receiving medications or herbal supplements known to be strong inducers of CYP3A4 (at least 3 weeks prior to first dose).
✕. Participants who have had only segmentectomies or wedge resections.
✕. History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer, or other solid tumours curatively treated with no evidence of disease for \> 5 years before the start of study intervention.
✕. Treatment with any of the following:
✕. 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.
✕. Any of the following cardiac criteria:
✕. Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD.