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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Qualitative Study to Identify Barriers and Facilitators of Persistence With 3rd Generation EGFR-TKI Osimertinib as Adjuvant Treatment (SECURE)
- ClinicalTrials.gov ID
- NCT07542210
- Acronym / sponsor ID
- SECURE / D516AR00002
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
2 secondary outcomes
Barriers and facilitators of persistence in different treatment duration cohorts
Time frame: Day of interview completion
Support needed by patients during their long-term treatment journey
Time frame: Day of interview completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by AstraZeneca at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barriers to persistence (time frame: Day of interview completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.