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NCT Number: NCT07542210

Barriers and Facilitators of Persistence With Adjuvant Osimertinib

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Barriers to persistence

    Time frame: Day of interview completion

    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.

  2. Facilitators of persistence

    Time frame: Day of interview completion

    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.

Secondary outcomes

  1. Barriers and facilitators of persistence in different treatment duration cohorts

    Time frame: Day of interview completion

    Barriers and facilitators of persistence in different treatment duration cohorts.

  2. Support needed by patients during their long-term treatment journey

    Time frame: Day of interview completion

    Support needed by patients during their long-term treatment journey: to highlight what additional information, tools, or services patients feel would help sustain persistence

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: SECURE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 21, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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