Lung Cancer Stage IIINCT07857694
Thoracic Radiotherapy Plus EGFR-TKI for Stage III EGFR-mutant Lung Adenocarcinoma
An observational study of Lung Cancer Stage III and EGFR Activating Mutation, run by Laibin People's Hospital at 1 site in China.
Trial summary
Objective: To investigate the failure patterns, efficacy and safety of thoracic radiotherapy combined with EGFR-TKI in stage III unresectable non-small cell lung cancer harboring EGFR-sensitive mutations. Methods: This is a multicenter retrospective cohort study. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lung Cancer Stage III, EGFR Activating Mutation
- What is being tested?
- Thoracic radiotherapy and EGFR-TKI
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 202 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 29 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retrospectively enrolled adult patients with stage III unresectable EGFR-mutant lung adenocarcinoma who received thoracic radiotherapy combined with EGFR-TKI therapy, from 5 participating hospitals.
Who may be able to join
- 1. Histologically confirmed lung adenocarcinoma. 2. Stage III unresectable non-small cell lung cancer. 3. Presence of EGFR sensitive mutation (exon 19 deletion or L858R). 4. Received thoracic radiotherapy combined with EGFR-TKI treatment. 5. Complete medical records available for retrospective data collection.
Who cannot join
- 1. Prior thoracic radiotherapy before the current treatment course. 2. Concurrent active malignant tumor. 3. Incomplete clinical, imaging or follow-up data. 4. Received radical surgical resection for lung cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patterns of Treatment Failure and Safety of Thoracic Radiotherapy Combined With EGFR-TKI in Stage III EGFR-mutant Lung Adenocarcinoma: a Multicenter Retrospective Cohort Study
Objective: To investigate the failure patterns, efficacy and safety of thoracic radiotherapy combined with EGFR-TKI in stage III unresectable non-small cell lung cancer harboring EGFR-sensitive mutations.
Methods: This is a multicenter retrospective cohort study. Patients diagnosed with stage III unresectable EGFR-mutant non-small cell lung cancer who received thoracic radiotherapy plus EGFR-TKI between January 1, 2020 and December 31, 2024 were enrolled from five hospitals in Guangxi, including Laibin People's Hospital, The People's Hospital of Chongzuo, Liuzhou Traditional Chinese Medical Hospital, The First People's Hospital of Yulin, and The First Affiliated Hospital of Guilin Medical University. We will analyze progression patterns, progression-free survival, overall survival and treatment-related adverse events.
- Conditions
- Lung Cancer Stage III, EGFR Activating Mutation
- Being tested
- Thoracic radiotherapy, EGFR-TKI
- Keywords
- Non-small cell lung carcinoma, EGFR mutation, stage III, thoracic radiotherapy, EGFR-TKI, retrospective cohort study
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic radiotherapyRadiation
Thoracic radiotherapy with IMRT, prescribed dose 54-66 Gy / 27-33 fractions.
EGFR-TKIDrug
EGFR tyrosine kinase inhibitors, including gefitinib, erlotinib, osimertinib, almonertinib; administered orally until disease progression or intolerable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving thoracic radiotherapy combined with EGFR-TKI | Multicenter retrospective cohort. Patients with stage III unresectable EGFR-sensitive mutant non-small cell lung cancer received thoracic radiotherapy (3DCRT or IMRT, prescribed dose 54-66 Gy / 27-33 fractions) combined with EGFR-TKIs (gefitinib, erlotinib, osimertinib, almonertinib). TKI was administered until disease progression or intolerable adverse events. This is a retrospective medical record review, no prospective intervention. Receives: Radiation: Thoracic radiotherapy; Drug: EGFR-TKI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pattern of treatment failure
The pattern of disease failure (local recurrence, regional lymph node recurrence, distant metastasis) after thoracic radiotherapy combined with EGFR-TKI.
Measured: From the start of thoracic radiotherapy until disease progression or death, whichever comes first.
Secondary outcomes (3)
Progression-free survival (PFS)
Time from the start of thoracic radiotherapy to disease progression or death from any cause.
Measured: Up to 5 years after radiotherapy initiation.
Overall survival (OS)
Time from the start of thoracic radiotherapy to death from any cause.
Measured: From radiotherapy start until 90 days after completion of radiotherapy.
Treatment-related adverse events
Incidence and grade of treatment-related adverse events.
Measured: From radiotherapy start until 90 days after completion of radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Jan 2020
- Primary completion31 Dec 2024
- Study completion29 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer Stage IIIStudies 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
- Retrospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laibin People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Gang, Laibin People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857694
- Sponsor's protocol ID
- LUNG-RT-TKI-202609
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers, because this retrospective study uses de-identified clinical medical records, and the raw data cannot be shared due to hospital data privacy and ethical restrictions. The aggregated study results will be published in peer-reviewed journals.
Publications
Liang J, et al. Concurrent thoracic radiotherapy plus EGFR-TKI for unresectable stage III EGFR-mutant NSCLC: a multicenter retrospective study. J Thorac Oncol. 2024;19(Suppl 2):S2345.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns of Treatment Failure and Safety of Thoracic Radiotherapy Combined With EGFR-TKI in Stage III EGFR-mutant Lung Adenocarcinoma: a Multicenter Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07857694
- Acronym / sponsor ID
- LUNG-RT-TKI-202609
- Conditions
- Lung Cancer Stage III, EGFR Activating Mutation
- Keywords
- Non-small cell lung carcinoma, EGFR mutation, stage III, thoracic radiotherapy, EGFR-TKI, retrospective cohort study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Laibin People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 29 Sep 2026 (actual)
- First posted
- 5 Oct 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.
Objective: To investigate the failure patterns, efficacy and safety of thoracic radiotherapy combined with EGFR-TKI in stage III unresectable non-small cell lung cancer harboring EGFR-sensitive mutations.
Methods: This is a multicenter retrospective cohort study. Patients diagnosed with stage III unresectable EGFR-mutant non-small cell lung cancer who received thoracic radiotherapy plus EGFR-TKI between January 1, 2020 and December 31, 2024 were enrolled from five hospitals in Guangxi, including Laibin People's Hospital, The People's Hospital of Chongzuo, Liuzhou Traditional Chinese Medical Hospital, The First People's Hospital of Yulin, and The First Affiliated Hospital of Guilin Medical University. We will analyze progression patterns, progression-free survival, overall survival and treatment-related adverse events.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving thoracic radiotherapy combined with EGFR-TKI | – | Radiation: Thoracic radiotherapy, Drug: EGFR-TKIMulticenter retrospective cohort. Patients with stage III unresectable EGFR-sensitive mutant non-small cell lung cancer received thoracic radiotherapy (3DCRT or IMRT, prescribed dose 54-66 Gy / 27-33 fractions) combined with EGFR-TKIs (gefitinib, erlotinib, osimertinib, almonertinib). TKI was administered until disease progression or intolerable adverse events. This is a retrospective medical record review, no prospective intervention. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospectively enrolled adult patients with stage III unresectable EGFR-mutant lung adenocarcinoma who received thoracic radiotherapy combined with EGFR-TKI therapy, from 5 participating hospitals.
Key inclusion criteria (1 listed)
- 1. Histologically confirmed lung adenocarcinoma. 2. Stage III unresectable non-small cell lung cancer. 3. Presence of EGFR sensitive mutation (exon 19 deletion or L858R). 4. Received thoracic radiotherapy combined with EGFR-TKI treatment. 5. Complete medical records available for retrospective data collection.
Key exclusion criteria (1 listed)
- 1. Prior thoracic radiotherapy before the current treatment course. 2. Concurrent active malignant tumor. 3. Incomplete clinical, imaging or follow-up data. 4. Received radical surgical resection for lung cancer.
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 |
|---|---|---|
| Thoracic radiotherapyThoracic radiotherapy with IMRT, prescribed dose 54-66 Gy / 27-33 fractions. | Radiation | Patients receiving thoracic radiotherapy combined with EGFR-TKI |
| EGFR-TKIEGFR tyrosine kinase inhibitors, including gefitinib, erlotinib, osimertinib, almonertinib; administered orally until disease progression or intolerable toxicity | Drug | Patients receiving thoracic radiotherapy combined with EGFR-TKI |
Primary outcome
Pattern of treatment failure
Time frame: From the start of thoracic radiotherapy until disease progression or death, whichever comes first.
The pattern of disease failure (local recurrence, regional lymph node recurrence, distant metastasis) after thoracic radiotherapy combined with EGFR-TKI.
3 secondary outcomes
Progression-free survival (PFS)
Time frame: Up to 5 years after radiotherapy initiation.
Overall survival (OS)
Time frame: From radiotherapy start until 90 days after completion of radiotherapy.
Treatment-related adverse events
Time frame: From radiotherapy start until 90 days after completion of radiotherapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Results publicationLiang J, et al. Concurrent thoracic radiotherapy plus EGFR-TKI for unresectable stage III EGFR-mutant NSCLC: a multicenter retrospective study. J Thorac Oncol. 2024;19(Suppl 2):S2345.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers, because this retrospective study uses de-identified clinical medical records, and the raw data cannot be shared due to hospital data privacy and ethical restrictions. The aggregated study results will be published in peer-reviewed journals.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Lung Cancer Stage III and EGFR Activating Mutation, run by Laibin People's 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 5 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pattern of treatment failure (time frame: From the start of thoracic radiotherapy until disease progression or death, whichever comes first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07857694, which also lists 1 linked publication.
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 5 Oct 2026.