Non-small Cell Lung CancerSECURENCT07542210
Barriers and Facilitators of Persistence With Adjuvant Osimertinib
An observational study of Non-small Cell Lung Cancer, run by AstraZeneca at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 13 Aug 2026to 30 Oct 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
- 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.
Who cannot join
- 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
- Unable or unwilling to follow study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
About this study
Official title: 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.
- Conditions
- Non-small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day of interview completion
Secondary outcomes (2)
Barriers and facilitators of persistence in different treatment duration cohorts
Barriers and facilitators of persistence in different treatment duration cohorts.
Measured: 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
Measured: Day of interview completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start13 Aug 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542210
- Sponsor's protocol ID
- D516AR00002
- Acronym
- SECURE
- Status last verified
- Oct 2026
- First submitted
- 14 Apr 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Individual data sharing
- Yes: 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.