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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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. 

The patient population will include adults aged ≥18 years with stage I-II unresected NSCLC.

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.

Treatment Pattern and Patient Outcomes among Stage I-II Unresected NSCLC Patients

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iTERESA Study Treatment Pattern and Patient Outcomes among Stage I-II Unresected NSCLC Patients.

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).

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.

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)

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).

The description will be based on patient-level information collected through the PRFs based on HCPs’ recall (Age class, sex, race).

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).

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).

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).

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).

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).

Treatment Pattern and Patient Outcomes among Stage I-II Unresected NSCLC Patients - iTERESA

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