Non-small Cell Lung CanceriTERESANCT07914972
Treatment Pattern and Patient Outcomes Among Stage I-II Unresected NSCLC Patients
An observational study of Non-small Cell Lung Cancer and NSCLC, run by AstraZeneca.
Trial summary
The iTERESA study is a retrospective, cross-sectional, non interventional, multi-country observational HCPs survey designed to characterize real-world management of adult patients with stage I-II unresected NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, NSCLC, Stage I-II Unresected NSCLC
- How many people
- 440 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to 30 Dec 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: The patient population will include adults aged ≥18 years with stage I-II unresected NSCLC.
Who may be able to join
- - Patient with unresected stage I-II NSCLC
- - Patient aged 18 years or older at the time of diagnosis
Who cannot join
- - Patients with anaplastic lymphoma kinase mutation (ALK)
- - Patients with previous history of cancer
- - Patients without post-diagnosis information
Trial locations and contacts
No sites are listed yet. 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: iTERESA Study Treatment Pattern and Patient Outcomes Among Stage I-II Unresected NSCLC Patients.
The iTERESA study is a retrospective, cross-sectional, non interventional, multi-country observational HCPs survey designed to characterize real-world management of adult patients with stage I-II unresected NSCLC.
- Keywords
- Non-small cell lung cancer, NSCLC, Stage I-II unresected NSCLC, Radiotherapy, SBRT, SABR, CFRT, Systemic therapy, Biomarker testing, Real-world evidence
- 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 |
|---|---|---|
| Adult patients with stage I-II unresected NSCLC | The patient population will include adults aged ≥18 years with stage I-II unresected NSCLC. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of real-world treatment patterns in adult patients with stage I-II unresected NSCLC as per HCP practice.
The description will be based on HCP practice according to treated/managed patients, questionnaire will be used to collect information (Type of RT administered, Intent of RT, Timing of RT relative to diagnosis, Managing approach following RT and use of systemic therapy, Type of systemic therapy following RT, Timing of systemic therapy following RT, RT interruption, Reasons for RT interruption).
Measured: 3 months
Description of real-world clinical outcomes in adult patients with stage I-II unresected NSCLC as per HCP practice.
The description will be based on HCP practice according to treated/managed patients, questionnaire will be used to collect information (Disease status after treatment, specifically evaluating proportion of patients remaining disease-free over time and NSCLC-related mortality over time. Timing between treatment and outcomes of interest, specifically evaluating proportion of patients experiencing disease recurrence over time and distribution of first recurrence type (local, regional, and distant) o Time-to-recurrence distribution by recurrence type.
Measured: 3 months
Secondary outcomes (8)
Description of patient-level treatment patterns in adult patients with stage I-II unresected NSCLC as per patient reported form (PRF) - based on HCPs' recall.
The description will be based on patient-level information collected through the PRFs based on HCPs' recall (Type of RT received, Intent of RT, Timing of RT relative to diagnosis, Performance of confirmatory biopsy prior to RT initiation, Systemic therapy following RT, Timing of systemic therapy following RT, RT interruption, Reasons for RT interruption)
Measured: 3 months
Description of patient-level clinical outcomes in adult patients with stage I-II unresected NSCLC as per PRF - based on HCPs' recall.
The description will be based on patient-level information collected through the PRFs based on HCPs' recall (Occurrence and type of treatment-related side effects during or after RT, Disease status after treatment, Most recent disease status after treatment completion, Timing between RT and outcomes of interest).
Measured: 3 months
Description of patient-level demographic of adult patients with stage I-II unresected NSCLC as per Patient Report Forms - based on Health Care Professionals recall.
The description will be based on patient-level information collected through the PRFs based on HCPs' recall (Age class, sex, race).
Measured: 3 Months
Description of patient-level clinical characteristics of adult patients with stage I-II unresected NSCLC as per Patient Report Forms - based on Health Care Professionals recall.
The description will be based on patient-level information collected through the Patient Report Forms based on HCPs' recall (Stage of NSCLC, TNM staging (excluding the M component), Histology, Eastern Cooperative Oncology Group (ECOG) performance status, Tumor location (central versus peripheral), Reason for non-resection, Specialist responsible for determining unresectability/non operability).
Measured: 3 months
Description of patient-level molecular testing patterns in adult patients with stage I-II unresected NSCLC as per PRF - based on HCPs' recall.
The description will be based on patient-level information collected through the PRFs based on HCPs' recall (Performance of EGFR test. Type of EGFR, Performance of PD-L1 test, PD-L1 expression status).
Measured: 3 months
Description of factors influencing treatment choice in adult patients with stage I-II unresected NSCLC according to Health Care Professionals practice based on treated/managed patients.
The description will be based on patient-level information collected through the Patient Report Forms based on HCPs' recall (Factors influencing the decision not to perform surgical resection, Specialist responsible for determining unresectability/non operability, Factors determining high-risk features definition, Factors determining initial RT treatment choice, separately by treatment (SBRT/SABR and CFRT), Performance of confirmatory biopsy prior to RT initiation, separately by treatment. (SBRT/SABR and CFRT), Factors determining the choice of administering/non-administering systemic therapy after RT, Influence of EGFR results on treatment choice, Influence of PD-L1 results on treatment choice).
Measured: 3 months
Description of molecular testing pattern in adult patients with stage I-II unresected NSCLC according to Health Care Professionals practice based on treated/managed patients.
The description will be based on patient-level information collected through the PRFs based on HCPs' recall (Frequency of performance of EGFR test, EGFR type frequency, Different barriers to EGFR testing, Frequency of performance of PD-L1 test, PD-L1 status frequency, Different barriers to PD-L1 testing).
Measured: 3 months
Description of Health Care Professionals perception towards the administration of systemic therapy following RT to adult patients with stage I-II unresected NSCLC.
The description will be based on information related to Health Care Pprofessionalss perception and practice (Strength of rationale for administering systemic therapy after RT, Barriers to systemic therapy use, Likelihood of prescription of systemic therapy, Category of patients who might benefit the most from systemic therapy according to systemic therapy type).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 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
- Other
- Time perspective
- Prospective
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914972
- Sponsor's protocol ID
- D133FR00271
- Acronym
- iTERESA
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iTERESA Study Treatment Pattern and Patient Outcomes Among Stage I-II Unresected NSCLC Patients.
- ClinicalTrials.gov ID
- NCT07914972
- Acronym / sponsor ID
- iTERESA / D133FR00271
- Keywords
- Non-small cell lung cancer, NSCLC, Stage I-II unresected NSCLC, Radiotherapy, SBRT, SABR, CFRT, Systemic therapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 4 Nov 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.
The iTERESA study is a retrospective, cross-sectional, non interventional, multi-country observational HCPs survey designed to characterize real-world management of adult patients with stage I-II unresected NSCLC.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with stage I-II unresected NSCLC | – | –The patient population will include adults aged ≥18 years with stage I-II unresected NSCLC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient population will include adults aged ≥18 years with stage I-II unresected NSCLC.
Key inclusion criteria (2 listed)
- - Patient with unresected stage I-II NSCLC
- - Patient aged 18 years or older at the time of diagnosis
Key exclusion criteria (3 listed)
- - Patients with anaplastic lymphoma kinase mutation (ALK)
- - Patients with previous history of cancer
- - Patients without post-diagnosis information
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
Description of real-world treatment patterns in adult patients with stage I-II unresected NSCLC as per HCP practice.
Time frame: 3 months
The description will be based on HCP practice according to treated/managed patients, questionnaire will be used to collect information (Type of RT administered, Intent of RT, Timing of RT relative to diagnosis, Managing approach following RT and use of systemic therapy, Type of systemic therapy following RT, Timing of systemic therapy following RT, RT interruption, Reasons for RT interruption).
Description of real-world clinical outcomes in adult patients with stage I-II unresected NSCLC as per HCP practice.
Time frame: 3 months
The description will be based on HCP practice according to treated/managed patients, questionnaire will be used to collect information (Disease status after treatment, specifically evaluating proportion of patients remaining disease-free over time and NSCLC-related mortality over time. Timing between treatment and outcomes of interest, specifically evaluating proportion of patients experiencing disease recurrence over time and distribution of first recurrence type (local, regional, and distant) o Time-to-recurrence distribution by recurrence type.
8 secondary outcomes
Description of patient-level treatment patterns in adult patients with stage I-II unresected NSCLC as per patient reported form (PRF) - based on HCPs' recall.
Time frame: 3 months
Description of patient-level clinical outcomes in adult patients with stage I-II unresected NSCLC as per PRF - based on HCPs' recall.
Time frame: 3 months
Description of patient-level demographic of adult patients with stage I-II unresected NSCLC as per Patient Report Forms - based on Health Care Professionals recall.
Time frame: 3 Months
Description of patient-level clinical characteristics of adult patients with stage I-II unresected NSCLC as per Patient Report Forms - based on Health Care Professionals recall.
Time frame: 3 months
Description of patient-level molecular testing patterns in adult patients with stage I-II unresected NSCLC as per PRF - based on HCPs' recall.
Time frame: 3 months
Description of factors influencing treatment choice in adult patients with stage I-II unresected NSCLC according to Health Care Professionals practice based on treated/managed patients.
Time frame: 3 months
Description of molecular testing pattern in adult patients with stage I-II unresected NSCLC according to Health Care Professionals practice based on treated/managed patients.
Time frame: 3 months
Description of Health Care Professionals perception towards the administration of systemic therapy following RT to adult patients with stage I-II unresected NSCLC.
Time frame: 3 months
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 4 Nov 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
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer and NSCLC, run by AstraZeneca.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Description of real-world treatment patterns in adult patients with stage I-II unresected NSCLC as per HCP practice. (time frame: 3 months). 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 4 Nov 2026.