Non-Small Cell Lung CancerNCT07686185
A Non-interventional, Real-world Study on the Adjuvant Treatment of Chinese EGFR-positive Stage IA NSCLC Patients With High-risk Factors Using Third-generation EGFR-TKIs.
An observational study of Non-Small Cell Lung Cancer and Adjuvant Therapy, run by First Affiliated Hospital of Guangxi Medical University at 1 site in China.
Trial summary
This study aims to evaluate the real-world effectiveness and safety of third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs)-such as osimertinib, aumolertinib, and furmonertinib-as adjuvant therapy for patients with early-stage non-small cell lung cancer (NSCLC) in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Adjuvant Therapy
- What is being tested?
- Third-generation EGFR-TKI
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 31 Dec 2032
- How long will I take part?
- 5 Years
- 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: This is a prospective, non-interventional, real-world study. The study population consists of 500 Chinese patients with stage IA NSCLC with high-risk factors and EGFR mutations. All participants have undergone or are planned to undergo surgical resection and are receiving or planned to receive third-generation EGFR-TKI adjuvant therapy according to the standard of care and the approved registration study protocol. Treatment duration is planned for up to 3 years until disease recurrence/progression, intolerable toxicity, withdrawal of consent, or completion of the 3-year treatment period. The study aims to collect data for final analysis without interfering with the patients' routine clinical treatment decisions.
Who may be able to join
- Age ≥ 18 years old
- Patients with IA-stage (8th edition of AJCC staging) non-small cell lung cancer (NSCLC) confirmed by histopathology and with high-risk factors
- EGFR mutation positive
- No previous systemic anti-tumor treatment
- Expected or already received surgical treatment
- Intended to receive or already received third-generation EGFR-TKI adjuvant therapy after surgery.
Who cannot join
- Small cell lung cancer
- With other malignant tumors that require treatment
- Pregnant or lactating women
- Those who the researchers consider not suitable to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Nuo Yang, +86-0771-5356708, yangnuogxmu@163.com
About this study
Official title: A Non-interventional, Real-World Study of Third-Generation EGFR-TKI Adjuvant Therapy in Chinese EGFR-Positive Stage IA Non-Small Cell Lung Cancer Patients With High-Risk Factors
This study aims to evaluate the real-world effectiveness and safety of third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs)-such as osimertinib, aumolertinib, and furmonertinib-as adjuvant therapy for patients with early-stage non-small cell lung cancer (NSCLC) in China.
Approximately 500 eligible patients are planned to be enrolled. All participants must have been diagnosed with Stage IA NSCLC (according to the 8th edition of the AJCC staging system) following surgical resection, harboring EGFR-sensitive mutations, and presenting with high-risk recurrence factors (e.g., poor differentiation, lymphovascular invasion, and spread through air spaces).
Read more
This is a non-interventional, real-world study that does not alter physicians' original prescribing habits or clinical management strategies. Patients will receive standard treatment with third-generation EGFR-TKIs according to routine clinical practice (typically for a duration of three years). The research team will periodically collect follow-up data, with a primary focus on postoperative disease-free survival (DFS) and drug safety profiles.
Through this investigation, we seek to determine whether this specific population of high-risk early-stage patients can derive clinical benefit from postoperative targeted therapy. The findings are expected to provide evidence to support the development of future clinical guidelines.
- Conditions
- Non-Small Cell Lung Cancer, Adjuvant Therapy
- Being tested
- Third-generation EGFR-TKI
- Keywords
- Non-Small Cell Lung Cancer, EGFR Mutation, Stage IA, High-risk Factors, Third-generation EGFR-TKI
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Third-generation EGFR-TKIDrug
This is an observational, non-interventional study. The interventions listed herein refer to routine standard adjuvant therapies administered entirely at the discretion and implementation of the attending physicians, without any interference from the study protocol. The research team is solely responsible for observing and collecting data, and does not participate in or influence patients' treatment decisions.
| Study group | Role | What they receive |
|---|---|---|
| Observational Group | Third-generation EGFR-TKI adjuvant therapy for Chinese patients with stage IA EGFR-positive NSCLC who have high-risk factors Receives: Drug: Third-generation EGFR-TKI |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-Year Disease-Free Survival Rate
The proportion of patients who did not PD or all-cause death after 3-years 3rd generation EGFR-TKIs adjuvant therapy
Measured: 3 years after 3rd generation EGFR-TKIs adjuvant therapy
Secondary outcomes (6)
5-Year Disease-Free Survival rate
The proportion of patients who did not PD or all-cause death after 3-years 3rd generation EGFR-TKIs adjuvant therapy
Measured: 5 years after 3rd generation EGFR-TKIs adjuvant therapy
Disease-free Survival (DFS)
From date of 3rd generation EGFR-TKIs adjuvant therapy started until date of disease recurrence or death (by any cause in the absence of recurrence).
Measured: Approximately 5 years
5-Year Overall Survival Rate
The proportion of patients alive at 5 years
Measured: 5 years after 3rd generation EGFR-TKIs adjuvant therapy
3-Year Overall Survival Rate
The proportion of patients alive at 3 years
Measured: 3 years after 3rd generation EGFR-TKIs adjuvant therapy
Overall Survival（OS）
From date of 3rd generation EGFR-TKIs adjuvant therapy started until date of death (by any cause in the absence of recurrence).
Measured: Approximately 5 years
Incidence of Adverse Events
The type, frequency and severity of adverse events during treatment (TEAE) and treatment-related adverse events (TRAE)
Measured: From the start of adjuvant therapy to 28 days after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2031 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686185
- Sponsor's protocol ID
- 2026-K0033
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a single-center retrospective observational study. Due to practical limitations in data management infrastructure and the lack of specific funding allocated for data sharing activities, the research team does not plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional, Real-World Study of Third-Generation EGFR-TKI Adjuvant Therapy in Chinese EGFR-Positive Stage IA Non-Small Cell Lung Cancer Patients With High-Risk Factors
- ClinicalTrials.gov ID
- NCT07686185
- Acronym / sponsor ID
- 2026-K0033
- Conditions
- Non-Small Cell Lung Cancer, Adjuvant Therapy
- Keywords
- Non-Small Cell Lung Cancer, EGFR Mutation, Stage IA, High-risk Factors, Third-generation EGFR-TKI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2031 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 7 Jul 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 study aims to evaluate the real-world effectiveness and safety of third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs)-such as osimertinib, aumolertinib, and furmonertinib-as adjuvant therapy for patients with early-stage non-small cell lung cancer (NSCLC) in China.
Approximately 500 eligible patients are planned to be enrolled. All participants must have been diagnosed with Stage IA NSCLC (according to the 8th edition of the AJCC staging system) following surgical resection, harboring EGFR-sensitive mutations, and presenting with high-risk recurrence factors (e.g., poor differentiation, lymphovascular invasion, and spread through air spaces).
This is a non-interventional, real-world study that does not alter physicians' original prescribing habits or clinical management strategies. Patients will receive standard treatment with third-generation EGFR-TKIs according to routine clinical practice (typically for a duration of three years). The research team will periodically collect follow-up data, with a primary focus on postoperative disease-free survival (DFS) and drug safety profiles.
Through this investigation, we seek to determine whether this specific population of high-risk early-stage patients can derive clinical benefit from postoperative targeted therapy. The findings are expected to provide evidence to support the development of future clinical guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Group | – | Drug: Third-generation EGFR-TKIThird-generation EGFR-TKI adjuvant therapy for Chinese patients with stage IA EGFR-positive NSCLC who have high-risk factors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective, non-interventional, real-world study. The study population consists of 500 Chinese patients with stage IA NSCLC with high-risk factors and EGFR mutations. All participants have undergone or are planned to undergo surgical resection and are receiving or planned to receive third-generation EGFR-TKI adjuvant therapy according to the standard of care and the approved registration study protocol. Treatment duration is planned for up to 3 years until disease recurrence/progression, intolerable toxicity, withdrawal of consent, or completion of the 3-year treatment period. The study aims to collect data for final analysis without interfering with the patients' routine clinical treatment decisions.
Key inclusion criteria (6 listed)
- Age ≥ 18 years old
- Patients with IA-stage (8th edition of AJCC staging) non-small cell lung cancer (NSCLC) confirmed by histopathology and with high-risk factors
- EGFR mutation positive
- No previous systemic anti-tumor treatment
- Expected or already received surgical treatment
Key exclusion criteria (4 listed)
- Small cell lung cancer
- With other malignant tumors that require treatment
- Pregnant or lactating women
- Those who the researchers consider not suitable to participate in this clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Third-generation EGFR-TKIThis is an observational, non-interventional study. The interventions listed herein refer to routine standard adjuvant therapies administered entirely at the discretion and implementation of the attending physicians, without any interference from the study protocol. The research team is solely responsible for observing and collecting data, and does not participate in or influence patients' treatment decisions. | Drug | Observational Group |
Primary outcome
3-Year Disease-Free Survival Rate
Time frame: 3 years after 3rd generation EGFR-TKIs adjuvant therapy
The proportion of patients who did not PD or all-cause death after 3-years 3rd generation EGFR-TKIs adjuvant therapy
6 secondary outcomes
5-Year Disease-Free Survival rate
Time frame: 5 years after 3rd generation EGFR-TKIs adjuvant therapy
Disease-free Survival (DFS)
Time frame: Approximately 5 years
5-Year Overall Survival Rate
Time frame: 5 years after 3rd generation EGFR-TKIs adjuvant therapy
3-Year Overall Survival Rate
Time frame: 3 years after 3rd generation EGFR-TKIs adjuvant therapy
Overall Survival（OS）
Time frame: Approximately 5 years
Incidence of Adverse Events
Time frame: From the start of adjuvant therapy to 28 days after the end of treatment
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 7 Jul 2026.
- Individual participant dataSharing planned: No. This is a single-center retrospective observational study. Due to practical limitations in data management infrastructure and the lack of specific funding allocated for data sharing activities, the research team does not plan to share individual participant data.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer and Adjuvant Therapy, run by First Affiliated Hospital of Guangxi Medical University at 1 site 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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Nuo Yang, Prof. (+86-0771-5356708, yangnuogxmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-Year Disease-Free Survival Rate (time frame: 3 years after 3rd generation EGFR-TKIs adjuvant therapy). 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 7 Jul 2026.