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Recruiting NCT07542210

Barriers and Facilitators of Persistence With Adjuvant Osimertinib

Conditions: Non-small Cell Lung Cancer

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 100
Sponsor: AstraZeneca

Location: Research Site Beijing

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.

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07542210). StuddyBuddy aggregates publicly available trial information.