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Treatment Pattern and Patient Outcomes Among Stage I-II Unresected NSCLC Patients (iTERESA)

28 octobre 2026 mis à jour par: AstraZeneca

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Type d'étude

Observationnel

Inscription (Estimé)

440

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

Inclusion Criteria:

  • - Patient with unresected stage I-II NSCLC
  • - Patient aged 18 years or older at the time of diagnosis

Exclusion Criteria:

  • - Patients with anaplastic lymphoma kinase mutation (ALK)
  • - Patients with previous history of cancer
  • - Patients without post-diagnosis information

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: OTHER
  • Perspectives temporelles: PROSPECTIVE

Cohortes et interventions

Groupe / Cohorte
Adult patients with stage I-II unresected NSCLC

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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Description of real-world treatment patterns in adult patients with stage I-II unresected NSCLC as per HCP practice.
Délai: 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).

3 months
Description of real-world clinical outcomes in adult patients with stage I-II unresected NSCLC as per HCP practice.
Délai: 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.

3 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
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.
Délai: 3 months

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)

3 months
Description of patient-level clinical outcomes in adult patients with stage I-II unresected NSCLC as per PRF - based on HCPs' recall.
Délai: 3 months

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).

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.
Délai: 3 Months

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

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.
Délai: 3 months

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).

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.
Délai: 3 months

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).

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.
Délai: 3 months

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).

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.
Délai: 3 months

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).

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.
Délai: 3 months

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).

3 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

30 octobre 2026

Achèvement primaire (Estimé)

30 décembre 2026

Achèvement de l'étude (Estimé)

30 décembre 2026

Dates d'inscription aux études

Première soumission

28 octobre 2026

Première soumission répondant aux critères de contrôle qualité

28 octobre 2026

Première publication (Réel)

4 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • D133FR00271

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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.

Délai de partage IPD

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Critères d'accès au partage IPD

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .