Barriers and Facilitators of Persistence With Adjuvant Osimertinib

NCT07542210 | Not Yet Recruiting

• 1 other identifier: D516AR00002
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Barriers and facilitators of persistence in different treatment duration cohorts

  Day of interview completion

• Support needed by patients during their long-term treatment journey

  Day of interview completion

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• Unable or unwilling to follow study procedures.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Tianjin, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

CN (1)