Non-Small Cell Lung CancerNCT07837739
Adjuvant EGFR-TKI Therapy After Surgery for EGFR-Mutant High-Risk Stage IA2-IIB NSCLC
An observational study of Non-Small Cell Lung Cancer, run by Tongji Hospital at 1 site in China.
Trial summary
This prospective, multicenter patient registry is designed to evaluate the effectiveness and safety of postoperative EGFR tyrosine kinase inhibitor (EGFR-TKI) therapy in patients with completely resected EGFR-mutant high-risk stage IA2 to stage IIB non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Adjuvant EGFR-TKI Therapy
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2025to 31 Dec 2026
- How long will I take part?
- 3 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 to 75 years
- All sexes
- Adult, Older adult
Study population: Adults with EGFR-mutant, completely resected high-risk stage IA2 to stage IIB NSCLC/lung adenocarcinoma who are treated and followed at participating thoracic oncology centers in Hubei Province, China.
Who may be able to join
- Age 18-75 years, male or female, with written informed consent.
- Histologically confirmed primary non-small cell lung cancer, pathologic stage IA2 to IIB; protocol summary further specifies lung adenocarcinoma / predominantly non-squamous histology.
- For stage IA2 disease, at least one protocol-defined high-risk feature: invasive component >2 cm; lymphovascular invasion; high-grade pattern comprising ≥20% solid, micropapillary, cribriform, or complex glandular components; spread through air spaces (STAS); or sublobar resection (segmentectomy/wedge resection).
- EGFR mutation-positive disease confirmed by the central laboratory, including exon 19 deletion, L858R, exon 20 insertion, or PACC mutation.
- Complete surgical resection with negative margins (R0); lobectomy or sublobar resection may be included according to the protocol.
- No previous antitumor treatment, including no neoadjuvant radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
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- ECOG Performance Status 0-1.
- Hematologic criteria: RBC ≥3.0×10^12/L; WBC ≥3.5×10^9/L; ANC ≥1.5×10^9/L; platelet count ≥100×10^9/L; hemoglobin ≥90 g/L.
- Renal function: serum creatinine ≤1.2×ULN.
- Hepatic function: total bilirubin ≤1.5×ULN; ALT and AST ≤1.5×ULN.
- Able and willing to comply with protocol-specified treatment/observation and follow-up.
- Adequate tumor tissue available and willingness to provide tissue and blood samples for study analyses.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study.
Who cannot join
- Contraindication to anesthesia or surgery, or death attributable to the surgical procedure before study enrollment/evaluation.
- Any systemic disease incompatible with participation in the clinical study or inability to provide written informed consent.
- Pregnancy or breastfeeding.
- Known active alcohol or drug abuse or dependence.
- Any serious or unstable medical condition or psychiatric disorder that, in the investigator's judgment, would make participation inappropriate.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.
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, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Wei Ping, 13437101581, pingwei@tjh.tjmu.edu.cn
About this study
Official title: A Multicenter Registry Study of Adjuvant EGFR-TKI Therapy Following Curative Resection for EGFR-Mutant High-Risk Stage IA2-IIB Non-Small Cell Lung Cancer
This prospective, multicenter patient registry is designed to evaluate the effectiveness and safety of postoperative EGFR tyrosine kinase inhibitor (EGFR-TKI) therapy in patients with completely resected EGFR-mutant high-risk stage IA2 to stage IIB non-small cell lung cancer. Approximately 100 adults aged 18 to 75 years will be enrolled across five participating centers. Eligible tumors must harbor an EGFR alteration, including exon 19 deletion, L858R, exon 20 insertion, or PACC mutations. High-risk stage IA2 disease is defined by at least one protocol-specified high-risk feature, including an invasive tumor component greater than 2 cm, lymphovascular invasion, a high-grade histologic pattern (at least 20% solid, micropapillary, cribriform, or complex glandular components), spread through air spaces, or sublobar resection.
Postoperative management, including adjuvant EGFR-TKI therapy or observation, is determined by routine clinical practice and patient/physician preference rather than assigned by the study. Participants are categorized by EGFR mutation type into common sensitizing mutations (Group A) and uncommon/resistant mutations (Group B), with clinical stage used for stratified analyses. The primary outcome is disease-free survival (DFS). Secondary outcomes include 2-, 3-, and 5-year DFS rates, overall survival (OS), 5-year OS, health-related quality of life measured using the SF-36, and safety outcomes. Tumor tissue and serial blood samples are collected for genomic and exploratory biomarker analyses.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Adjuvant EGFR-TKI Therapy
- 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.
Adjuvant EGFR-TKI TherapyDrug
Routine-care postoperative EGFR-TKI therapy. First-generation options include gefitinib, erlotinib, and icotinib; third-generation options include furmonertinib, osimertinib, and almonertinib. Maximum planned duration is 3 years.
| Study group | Role | What they receive |
|---|---|---|
| Common Sensitizing EGFR Mutation Cohort | Participants with common sensitizing EGFR mutations, including exon 19 deletion and L858R, following complete surgical resection of high-risk stage IA2-IIB NSCLC. Receives: Drug: Adjuvant EGFR-TKI Therapy | |
| Uncommon/Resistant EGFR Mutation Cohort | Participants with uncommon or resistant EGFR mutations, including exon 20 insertion and PACC mutations, following complete surgical resection of high-risk stage IA2-IIB NSCLC. Receives: Drug: Adjuvant EGFR-TKI Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival (DFS)
Time from the date of surgery to investigator-confirmed disease recurrence or death from any cause, whichever occurs first.
Measured: From surgery until disease recurrence or death, assessed up to 3 years
Secondary outcomes (6)
2-Year Disease-Free Survival Rate
Measured: 2 years after surgery.
Overall Survival (OS)
Measured: From date of enrollment until the date of death from any cause, assessed up to 60 months
5-Year Disease-Free Survival Rate
Measured: 5 years after surgery
5-Year Overall Survival Rate
Measured: 5 years after surgery
Incidence and Severity of Adverse Events
Measured: Baseline, after 2 weeks of treatment, after 4 weeks of treatment, after 12 weeks of treatment, and every 12 weeks thereafter until date of death from any cause, assessed up to 60 months
Change in SF-36 Health-Related Quality of Life Scores
Measured: Baseline, after 2 weeks of treatment, after 4 weeks of treatment, after 12 weeks of treatment, every 12 weeks during the first 3 years, and every 6 months thereafter until date of death from any cause, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start2 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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.
- More trials run by Tongji HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Ni, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837739
- Sponsor's protocol ID
- TJ-IRB202506003
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Registry Study of Adjuvant EGFR-TKI Therapy Following Curative Resection for EGFR-Mutant High-Risk Stage IA2-IIB Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07837739
- Acronym / sponsor ID
- TJ-IRB202506003
- Conditions
- Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Sep 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 prospective, multicenter patient registry is designed to evaluate the effectiveness and safety of postoperative EGFR tyrosine kinase inhibitor (EGFR-TKI) therapy in patients with completely resected EGFR-mutant high-risk stage IA2 to stage IIB non-small cell lung cancer. Approximately 100 adults aged 18 to 75 years will be enrolled across five participating centers. Eligible tumors must harbor an EGFR alteration, including exon 19 deletion, L858R, exon 20 insertion, or PACC mutations. High-risk stage IA2 disease is defined by at least one protocol-specified high-risk feature, including an invasive tumor component greater than 2 cm, lymphovascular invasion, a high-grade histologic pattern (at least 20% solid, micropapillary, cribriform, or complex glandular components), spread through air spaces, or sublobar resection.
Postoperative management, including adjuvant EGFR-TKI therapy or observation, is determined by routine clinical practice and patient/physician preference rather than assigned by the study. Participants are categorized by EGFR mutation type into common sensitizing mutations (Group A) and uncommon/resistant mutations (Group B), with clinical stage used for stratified analyses. The primary outcome is disease-free survival (DFS). Secondary outcomes include 2-, 3-, and 5-year DFS rates, overall survival (OS), 5-year OS, health-related quality of life measured using the SF-36, and safety outcomes. Tumor tissue and serial blood samples are collected for genomic and exploratory biomarker analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Common Sensitizing EGFR Mutation Cohort | – | Drug: Adjuvant EGFR-TKI TherapyParticipants with common sensitizing EGFR mutations, including exon 19 deletion and L858R, following complete surgical resection of high-risk stage IA2-IIB NSCLC. |
| Uncommon/Resistant EGFR Mutation Cohort | – | Drug: Adjuvant EGFR-TKI TherapyParticipants with uncommon or resistant EGFR mutations, including exon 20 insertion and PACC mutations, following complete surgical resection of high-risk stage IA2-IIB NSCLC. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults with EGFR-mutant, completely resected high-risk stage IA2 to stage IIB NSCLC/lung adenocarcinoma who are treated and followed at participating thoracic oncology centers in Hubei Province, China.
Key inclusion criteria (13 listed)
- Age 18-75 years, male or female, with written informed consent.
- Histologically confirmed primary non-small cell lung cancer, pathologic stage IA2 to IIB; protocol summary further specifies lung adenocarcinoma / predominantly non-squamous histology.
- For stage IA2 disease, at least one protocol-defined high-risk feature: invasive component >2 cm; lymphovascular invasion; high-grade pattern comprising ≥20% solid, micropapillary, cribriform, or complex glandular components; spread through air spaces (STAS); or sublobar resection (segmentectomy/wedge resection).
- EGFR mutation-positive disease confirmed by the central laboratory, including exon 19 deletion, L858R, exon 20 insertion, or PACC mutation.
- Complete surgical resection with negative margins (R0); lobectomy or sublobar resection may be included according to the protocol.
Key exclusion criteria (6 listed)
- Contraindication to anesthesia or surgery, or death attributable to the surgical procedure before study enrollment/evaluation.
- Any systemic disease incompatible with participation in the clinical study or inability to provide written informed consent.
- Pregnancy or breastfeeding.
- Known active alcohol or drug abuse or dependence.
- Any serious or unstable medical condition or psychiatric disorder that, in the investigator's judgment, would make participation inappropriate.
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 |
|---|---|---|
| Adjuvant EGFR-TKI TherapyRoutine-care postoperative EGFR-TKI therapy. First-generation options include gefitinib, erlotinib, and icotinib; third-generation options include furmonertinib, osimertinib, and almonertinib. Maximum planned duration is 3 years. | Drug | Common Sensitizing EGFR Mutation Cohort, Uncommon/Resistant EGFR Mutation Cohort |
Primary outcome
Disease-Free Survival (DFS)
Time frame: From surgery until disease recurrence or death, assessed up to 3 years
Time from the date of surgery to investigator-confirmed disease recurrence or death from any cause, whichever occurs first.
6 secondary outcomes
2-Year Disease-Free Survival Rate
Time frame: 2 years after surgery.
Overall Survival (OS)
Time frame: From date of enrollment until the date of death from any cause, assessed up to 60 months
5-Year Disease-Free Survival Rate
Time frame: 5 years after surgery
5-Year Overall Survival Rate
Time frame: 5 years after surgery
Incidence and Severity of Adverse Events
Time frame: Baseline, after 2 weeks of treatment, after 4 weeks of treatment, after 12 weeks of treatment, and every 12 weeks thereafter until date of death from any cause, assessed up to 60 months
Change in SF-36 Health-Related Quality of Life Scores
Time frame: Baseline, after 2 weeks of treatment, after 4 weeks of treatment, after 12 weeks of treatment, every 12 weeks during the first 3 years, and every 6 months thereafter until date of death from any cause, assessed up to 60 months
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 23 Sep 2026.
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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, run by Tongji Hospital 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 13 inclusion and 6 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 23 Sep 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 Wei Ping, Dr. (13437101581, pingwei@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Survival (DFS) (time frame: From surgery until disease recurrence or death, assessed up to 3 years). 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 23 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.