Barriers and facilitators to sticking with osimertinib after early-stage NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a cross-sectional qualitative study that uses individual interviews to explore factors influencing persistence with adjuvant osimertinib in early-stage NSCLC. About 100 participants will be enrolled, including around 85 patients and 15 physicians, and will be interviewed online or in person using a COM-B based guide. Interviews will be conducted in waves, recorded, transcribed, and analyzed with both deductive and inductive methods to identify barriers and facilitators. The study is observational and non-interventional, focusing on real-world experiences with the 3rd generation EGFR-TKI in China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  Beijing, China Recruiting

Study contacts

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.