Lung CancerECHONCT07593248
Real-World Outcomes of Resected EGFR-Mutated NSCLC Patients Treated With Adjuvant EGFR-TKI in China
An observational study of Lung Cancer, run by AstraZeneca at 14 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 2,000 participants
- Where
- 14 sitesChina
- Study dates
- 22 Jun 2026to 30 Jun 2031
- 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: stage IB to III NSCLC who have received adjuvant EGFR-TKI therapy.
Who may be able to join
- Diagnosed stage IB-III NSCLC on or prior to the index date;
- Initiated adjuvant EGFR-TKI from July 1st, 2023 to June 30th, 2026
Who cannot join
None listed.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
14 sites in 1 country
China14 sites, 14 recruiting
- Not yet recruiting
Research Site
Beijing
- Not yet recruiting
Research Site
Chengdu
- Not yet recruiting
Research Site
Fuzhou
- Recruiting
Research Site
Guangzhou
- Not yet recruiting
Research Site
Guangzhou
- Not yet recruiting
Research Site
Nanchang
- Not yet recruiting
Research Site
Shanghai
- Not yet recruiting
Research Site
Shenyang
- Not yet recruiting
Research Site
Shijiazhuang
- Not yet recruiting
Research Site
Tianjin
- Not yet recruiting
Research Site
Wuhan
- Not yet recruiting
Research Site
Xi'an
- Not yet recruiting
Research Site
Xuzhou
- Not yet recruiting
Research Site
Zhengzhou
About this study
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.
Read the detailed description
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.
- Conditions
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effectiveness in real world of EGFR-TKI adjuvant therapy in resected NSCLC as measured by 5-year OS rate
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
Measured: from enrollment up to 5 years after treatment initiation
Secondary outcomes (4)
To assess the effectiveness in real world of EGFR-TKI adjuvant therapy in resected as measured by 2, 3, 4, 5-year DFS rate
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
Measured: from enrollment up to 5 years after treatment initiation
To assess the treatment duration and reason for discontinuation in real world of EGFR-TKI adjuvant therapy in resected NSCLC
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.
Measured: from enrollment up to 5 years after treatment initiation
To assess the treatment duration and reason for discontinuation in real world of EGFR-TKI adjuvant therapy in resected NSCLC
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.
Measured: from enrollment up to 5 years after treatment initiation
To assess the safety of EGFR-TKI used as an adjuvant， neoadjuvant therapy and used for post recurrence in resected NSCLC
Safety will be evaluated in terms of SAEs and AEs leading to death
Measured: from enrollment up to 5 years after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start22 Jun 2026
- Primary completion30 Jun 2031 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593248
- Sponsor's protocol ID
- D5164R00012
- Acronym
- ECHO
- Status last verified
- Aug 2026
- First submitted
- 12 May 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- 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 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Outcomes of Resected EGFR-Mutated NSCLC Patients Treated With Adjuvant EGFR-TKI in China
- ClinicalTrials.gov ID
- NCT07593248
- Acronym / sponsor ID
- ECHO / D5164R00012
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- 30 Jun 2031 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 18 May 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.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- stage IB to III NSCLC who have received adjuvant EGFR-TKI therapy.
Key inclusion criteria (2 listed)
- Diagnosed stage IB-III NSCLC on or prior to the index date;
- Initiated adjuvant EGFR-TKI from July 1st, 2023 to June 30th, 2026
Key exclusion criteria (0 listed)
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
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
4 secondary outcomes
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
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
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
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
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 13 Aug 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
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by AstraZeneca at 14 sites in China.
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 0 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: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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). 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 13 Aug 2026.