A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection

Phase 3

Active, not recruiting

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: Placebo; Drug: Osimertinib

• Registration Number: NCT05120349
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

This is a Phase III, double-blind, randomised, placebo-controlled, 2-arm, international study assessing the efficacy and safety of adjuvant osimertinib versus placebo in participants with stage IA2-IA3 EGFRm Non-Small Cell Lung Cancer, who have previously undergone complete tumour resection. All participants must have had a tumour which harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R).

Eligible participants will be randomised in a 1:1 ratio to one of the 2 intervention arms: osimertinib 80 mg or matching placebo, once daily for 3 years unless discontinuation criteria is met.

Study Timeline

• Study First Submitted: 2021-11-03
• Study First Submitted QC: 2021-11-03
• Study First Posted: 2021-11-15
• Study Start: 2022-02-21
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-19
• Primary Completion: 2027-08-02
• Study Completion: 2032-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo for osimertinib, orally, once daily
Osimertinib	Osimertinib	Osimertinib 80mg, orally, once daily (Dose may be reduced to 40 mg once daily if required at the discretion of the investigator)

Primary Outcome Measures

Name	Time	Method
Disease-Free Survival (DFS) in high-risk stratum	From date of randomisation up to approximately 10 years	DFS is defined as the time from the date of randomisation until the date of disease recurrence or date of death (by any cause in the absence of recurrence), whichever occurs first.; Stratification to the high risk stratum will be based on pathologic features assessed by central pathology review during screening.

Secondary Outcome Measures

Name	Time	Method
PK plasma concentrations of osimertinib and of metabolite AZ5104 in overall population	From date of randomisation up to approximately 10 years	Ratio of metabolite-to-osimertinib to be calculated at predose, and at 0.5-2 hours postdose.
Overall Survival (OS) in high-risk stratum and the overall population	From date of randomization up to approximately 10 years	OS is defined as the time from the date of randomisation until death due to any cause.
Impact of osimertinib versus placebo on physical functioning	From date of randomisation up to approximately 10 years	Assess the impact of osimertinib versus placebo on physical functioning in both the high-risk stratum and the overall population as measured by SF-36 V2 health survey
Central Nervous System (CNS) Disease-Free Survival (DFS) in both the high-risk stratum and the overall population	From date of randomisation up to approximately 10 years	CNS DFS is defined as the time from randomisation to the time of a CNS lesion (as assessed by investigator) or death due to any cause, regardless of whether the participant withdraws from study intervention or receives other anti-cancer therapy.
Safety and tolerability in overall population	From date of randomisation up to approximately 10 years	AEs graded by CTCAE version 5.0
Disease-Free Survival (DFS) in overall population	From date of randomisation up to approximately 10 years	DFS is defined as the time from the date of randomisation until the date of disease recurrence or date of death (by any cause in the absence of recurrence), whichever occurs first.

Trial Locations

Locations (1)

Research Site; 🇻🇳 Ho Chi Minh, Vietnam