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NCT Number: NCT07593248

Real-World Outcomes of Resected EGFR-Mutated NSCLC Patients Treated With Adjuvant EGFR-TKI in China

This is a multi-centre, observational study, with retrospective data collection and prospective active follow-up. The aim is to measure the treatment pattern and real-world outcomes of EGFR-TKI as an adjuvant therapy in patients with early-stage EGFR-mutated NSCLC. The study period ranges from July 1st, 2022 to June 30th, 2031. Approximately 2,000 patients will be enrolled from 15 sites in China.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Guangzhou, China

Location status: Recruiting

About this study

This is a multi-centre, observational study, with retrospective data collection and prospective active follow-up. The study will enroll adult patients from China with resected, stage IB to III NSCLC who have received adjuvant EGFR-TKI therapy. Approximately 2,000 patients will be enrolled from 15 sites in China.

Patients will be followed up from the index date to the earliest of death, loss to follow-up, or the end of study. Data accumulated before informed consent will be collected retrospectively. For prospective data collection, every 12-week data collection frequency will be performed for the first 1-year from index date; and every 24-week data collection frequency will be performed afterward until the end of follow-up. All study-relevant data occurring during the follow-up period will be captured irrespective of planned follow-up frequency, with collection conducted via medical record abstraction and/or telephone interviews.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed stage IB-III NSCLC on or prior to the index date;
  • Initiated adjuvant EGFR-TKI from July 1st, 2023 to June 30th, 2026

Treatment and study plan

Primary outcomes

  1. To assess the effectiveness in real world of EGFR-TKI adjuvant therapy in resected NSCLC as measured by 5-year OS rate

    Time frame: from enrollment up to 5 years after treatment initiation

    OS is defined as the time from the first dose of EGFR-TKI adjuvant therapy until the date of death due to any cause. The analysis will include all patients received EGFR-TKI adjuvant therapy during the study. All deaths will be included, regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy.

    The primary measure of interest is the OS rate at 5 years

Secondary outcomes

  1. To assess the effectiveness in real world of EGFR-TKI adjuvant therapy in resected as measured by 2, 3, 4, 5-year DFS rate

    Time frame: from enrollment up to 5 years after treatment initiation

    Real-world DFS landmark

    rwDFS is defined as from date of first adjuvant EGFR-TKI to first documented recurrence or death. Patient without known recurrence or death would be censored at the last date of follow-up.

    DFS rate at 2, 3, 4 and 5 years

  2. To assess the treatment duration and reason for discontinuation in real world of EGFR-TKI adjuvant therapy in resected NSCLC

    Time frame: from enrollment up to 5 years after treatment initiation

    Time to treatment discontinuation (TTD) of adjuvant EGFR-TKI is defined as the time from initiation of adjuvant EGFR-TKI to the earlier of the date of adjuvant therapy discontinuation or death.

    The primary measure of interest is median TTD. Reason for discontinuation would be collected.

  3. To assess the treatment duration and reason for discontinuation in real world of EGFR-TKI adjuvant therapy in resected NSCLC

    Time frame: from enrollment up to 5 years after treatment initiation

    Time to next treatment (TTNT) for adjuvant EGFR-TKI class is defined as time from initiation of adjuvant EGFR-TKI to start date of the next alternative systemic anti-cancer therapy other than EGFR-TKI, add on anti-cancer therapy or death. The primary measure of interest is median TTNT.

  4. To assess the safety of EGFR-TKI used as an adjuvant， neoadjuvant therapy and used for post recurrence in resected NSCLC

    Time frame: from enrollment up to 5 years after treatment initiation

    Safety will be evaluated in terms of SAEs and AEs leading to death

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: ECHO

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
May 18, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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