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

2026年10月28日 更新者: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.

研究概览

研究类型

观察性的

注册 (估计的)

440

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:OTHER
  • 时间观点:PROSPECTIVE

队列和干预

团体/队列
Adult patients with stage I-II unresected NSCLC

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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Description of real-world treatment patterns in adult patients with stage I-II unresected NSCLC as per HCP practice.
大体时间: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.
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
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.
大体时间: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.
大体时间: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.
大体时间: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.
大体时间: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.
大体时间: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.
大体时间: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.
大体时间: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.
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月30日

初级完成 (估计的)

2026年12月30日

研究完成 (估计的)

2026年12月30日

研究注册日期

首次提交

2026年10月28日

首先提交符合 QC 标准的

2026年10月28日

首次发布 (实际的)

2026年11月4日

研究记录更新

最后更新发布 (实际的)

2026年11月4日

上次提交的符合 QC 标准的更新

2026年10月28日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

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.

IPD 共享时间框架

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.

IPD 共享访问标准

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.

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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