Barriers and Facilitators of Persistence With Adjuvant Osimertinib (SECURE)

Cross-sectional Qualitative Study to Identify Barriers and Facilitators of Persistence With 3rd Generation EGFR-TKI Osimertinib as Adjuvant Treatment (SECURE)

This is a cross-sectional, non-interventional qualitative study using individual interviews to investigate determinants of persistence with 3rd generation EGFR-TKI osimertinib as adjuvant therapy among patients with early-stage NSCLC in China. Approximately 100 participants will be enrolled, comprising around 85 patients and 15 physicians. All participants will be interviewed online or in-person using a COM-B (Capability, Opportunity, Motivation - Behaviour) based guide. Interviews will be conducted in waves, recorded, transcribed, and analysed using both deductive and inductive methods.

Study Overview

• Status: Recruiting
• Conditions: Non-small Cell Lung Cancer

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Include adult patients with early-stage NSCLC who received adjuvant osimertinib after curative surgery, as well as physicians experienced in prescribing adjuvant osimertinib.

Description

For patient

Inclusion Criteria:

• Adults (≥18 years) with NSCLC who have received osimertinib as the 3rd generation EGFR-TKI adjuvant therapy and meet one of the following: Patients who received adjuvant osimertinib for less than 34 months and discontinued treatment (off treatment), or Patients who received adjuvant osimertinib for at least 34 months (either off treatment or still on treatment).
• For off treatment patients, discontinuation or completion of osimertinib is required to occur within 6 months by screening.
• Willing and able to provide informed consent, participate in an online or in-person qualitative interview, and permit audio recording for research purposes.

Exclusion Criteria:

• Prior receipt of 3rd generation EGFR-TKI as adjuvant therapy as part of any interventional clinical trial.
• Prior receipt of 1st generation EGFR-TKIs as adjuvant therapy.
• Evidence of cognitive impairment that would likely to interfere with participation in an interview, as informally assessed during screening.
• Unaware of or do not understand their own medical condition.

For physicians

Inclusion Criteria:

• Licensed medical oncologists, thoracic surgeons, or pulmonologists with experience of prescribing osimertinib as adjuvant treatment and actively managing patients who will participate the interview.
• Managed 5 patients with early-stage NSCLC receiving osimertinib within the past 6 months.
• Holding a professional title equivalent to or higher than attending physician.
• Willing and able to provide informed consent, participate in an online or in-person qualitative interview, and permit audio recording for research purposes.

Exclusion Criteria:

• Unable or unwilling to follow study procedures.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Interview-Physicians; Interview the physicians experienced in prescribing osimertinib and managing osimertinib-treated patients
Interview-Patients; Interview the Patients with treated with osimertinib for less 6 months, 6-18 months, 18-34 months, more than 34 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barriers to persistence	to identify factors that prevent patients from maintaining persistence to osimertinib adjuvant treatment. Barriers may include adverse effects, logistical challenges, financial constraints, psychosocial issues, communication gaps, etc.	Day of interview completion
Facilitators of persistence	to determine factors that support patients in continuing osimertinib adjuvant treatment. Facilitators may include perceived efficacy, effective management of side effects, strong physician-patient communication, practical supports, family or peer encouragement, etc.	Day of interview completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barriers and facilitators of persistence in different treatment duration cohorts	Barriers and facilitators of persistence in different treatment duration cohorts.	Day of interview completion
Support needed by patients during their long-term treatment journey	Support needed by patients during their long-term treatment journey: to highlight what additional information, tools, or services patients feel would help sustain persistence	Day of interview completion

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): September 1, 2026
• Last Update Submitted That Met QC Criteria: August 28, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: D516AR00002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.