NCT05526755
Active, not recruiting
Phase 2
An Open-label, Single-arm, Phase II, Multinational, Multicentre Study to Assess the Efficacy and Safety of 5 Years of Osimertinib in Participants With EGFRm-positive Stage II-IIIB NSCLC, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy
InterventionsOsimertinib 80 mg/40 mg
Overview
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- AstraZeneca
- Enrollment
- 188
- Locations
- 56
- Primary Endpoint
- Estimate the Efficacy of Osimertinib as Measured by Disease Free Survival (DFS) [Common EGFRm Cohort].
Overview
Brief 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.
Detailed Description
This is a phase 2 open-label study to assess the efficacy and safety of osimertinib in participants with stage II-IIIB NSCLC with sensitising EGFR mutations. The study is designed to evaluate 5 years of adjuvant osimertinib therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 130 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Female participants must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of childbearing potential.
- •Male participants must use effective barrier contraception.
Exclusion Criteria
- •Major surgery (including primary tumour surgery, excluding placement of vascular access) within 4 weeks prior to the first dose of study drug.
- •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:
- •Pre-operative or post-operative or planned radiation therapy for the current lung cancer.
- •Pre-operative (neo-adjuvant) platinum-based or other chemotherapy.
- •Any prior anti-cancer or immunological therapy, including investigational therapy, for treatment of NSCLC other than standard platinum-based doublet post-operative adjuvant chemotherapy.
- •Prior treatment with neoadjuvant or adjuvant EGFR tyrosine kinase inhibitor (TKI).
- •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.
Arms & Interventions
Osimertinib
Experimental
Participants will receive osimertinib (AZD9291).
Intervention: Osimertinib 80 mg/40 mg (Drug)
Outcomes
Primary Outcomes
Estimate the Efficacy of Osimertinib as Measured by Disease Free Survival (DFS) [Common EGFRm Cohort].
Time Frame: 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.
Defined as time from date of first dose until disease recurrence, or death due to any cause in the absence of recurrence.
Secondary Outcomes
- Disease Free Survival Rate at 3, 4 and 5 Years (Uncommon EGFRm Cohort)(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 3 years, 4 years, and 5 years.)
- DFS Rate at 3 and 4 Years (Common EGFRm Cohort)(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 3 years, and 4 years.)
- Overall Survival (OS) [Common EGFRm Cohort](From date of first dose until the date of death due to any cause, up to approximately 5 years. Assessed at 3 years, 4 years, and 5 years.)
- Safety and tolerability in overall population (Common EGFRm Cohort and Uncommon EGFRm Cohort)(From date of first dose up to approximately 5 years)
- Recurrence events in overall population (Common EGFRm Cohort and Uncommon EGFRm Cohort)(From date of first dose up to approximately 5 years)
Investigators
Study Sites (56)
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