Third-generation TKINCT06613633
Third-generation EGFR-TKI Treatment in Metastatic EGFR-mutant NSCLC
An observational study of Third-generation TKI and NSCLC (Advanced Non-small Cell Lung Cancer), run by Fudan University at 3 sites in China.
Trial summary
The goal of this observational study is to explore the feasibility of stereotactic radiotherapy (SRT) as consolidation therapy for patients with advanced non-small-cell lung cancer who were treated with third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Third-generation TKI, NSCLC (Advanced Non-small Cell Lung Cancer)
- What is being tested?
- third-generation EGFR-TKI (Osimertinib, Almonertinib or Furmonertinib)
- How many people
- 4,000 participants
- Where
- 3 sitesChina
- Study dates
- 1 Sep 2018to 20 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Advanced EGFR-mutant NSCLC patients receiving third-generation EGFR-TKIs are enrolled
Who may be able to join
- Pathologically confirmed non-small cell lung cancer;
- clinical stage IV (AJCC, 8th edition, 2017);
- EGFR sensitizing mutations (L858R or 19del);
- age≥18 years old;
- KPS score≥70;
- complete systemic imaging (including brain MRI) before third-generation EGFR-TKI treatment;
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- received standard third-generation EGFR-TKI therapy (monotherapy or combined with brain radiotherapy);
- willing to cooperate with the follow-up after third-generation EGFR-TKI treatment;
- informed consent of the patient.
Who cannot join
- Multiple primary or metastatic tumors (except early skin cancer, cervical carcinoma in situ that has been treated radically, with no recurrence or progression for more than 5 years);
- Pregnant or lactating women who, as judged by the investigator, were not candidates for brain MRI;
- Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the signing of the informed consent form or affect patient compliance.;
- patients without EGFR sensitive mutations or with unknown EGFR mutation status.
- Withdrawal criteria
- The investigators considered that the patients had poor adherence to the study protocol.
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- The patient withdrew informed consent and asked to withdraw.
- There was any safety reason (adverse event) considered by the investigator;
- Due to other underlying diseases, side effects, economic factors, and other reasons, patients did not receive regular doses of third-generation EGFR-TKI (continuous withdrawal time more than 1 week, cumulative withdrawal time more than 2 weeks, etc.).
- The patient was not followed up according to the protocol.
- Other circumstances in which withdrawal from the study was deemed necessary by the investigator.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200050
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
Wuhan Tongji Hospital
Wuhan, Hubei, 430030
About this study
Official title: Pattern of Failure and Feasibility of Consolidative Stereotactic Radiotherapy in Third-generation EGFR-TKI-treated Metastatic EGFR-mutant Non-small Cell Lung Cancer: A Prospective, Observational Study
The goal of this observational study is to explore the feasibility of stereotactic radiotherapy (SRT) as consolidation therapy for patients with advanced non-small-cell lung cancer who were treated with third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). The investigators plan to explore the time to achieve the best response after EGFR-TKI treatment, the characteristics of the distribution of lesions when the best response is achieved, the feasibility of SRT when the best response is achieved, and the phenotype of disease progression after EGFR-TKI resistance.
In summary, this study will provide critical information for exploring the feasibility and optimal design of SRT as consolidation therapy for advanced NSCLC patients treated with third-generation EGFR-TKI, which will further promote the optimization of comprehensive treatment for EGFR-mutant advanced NSCLC.
- Being tested
- third-generation EGFR-TKI (Osimertinib, Almonertinib or Furmonertinib)
- Keywords
- NSCLC, EGFR
- 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-TKI (Osimertinib, Almonertinib or Furmonertinib)Drug
Patients with advanced EGFR-mutated NSCLC who met the inclusion criteria and received third-generation EGFR-TKI (monotherapy or combined with brain radiotherapy)
| Study group | Role | What they receive |
|---|---|---|
| third-generation EGFR-TKI monotherapy | Not described Receives: Drug: third-generation EGFR-TKI (Osimertinib, Almonertinib or Furmonertinib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Best Response
The time from the first day of third-generation EGFR-TKI treatment to the point at which the smallest tumor burden is observed on imaging studies.
Measured: 5 years
Secondary outcomes (2)
Distribution of Tumor Lesions at Best Response
the distribution of tumor lesions at the time when the smallest tumor burden is observed on imaging. Focus on whether the remaining lesions are suitable for consolidative stereotactic radiotherapy, per the relevant criteria endorsed by the NRG-BR001 study.
Measured: 5 years
Phenotypes of Disease Progression After Third-Generation EGFR-TKI Resistance
Tumor distribution when disease progression occurs during third-generation EGFR-TKI treatment (disease progression is defined by RECIST 1.1 criteria). The pattern of progressive disease will be classified into the following three types based on imaging assessment:
- Original Site Failure (OF): Progression of lesions that were present at baseline (enlargement of existing lesions).
- Distant Site Failure (DF): New tumor lesions occurring in areas where no lesions were present at baseline.
- Original and Distant site failure (ODF): The coexistence of the two situations mentioned above.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 Sep 2018
- Primary completion1 Aug 2024
- Study completion20 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Third-generation TKIStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Chest Hospital, Wuhan TongJi Hospital
- Responsible party
- Principal investigator, Zhengfei Zhu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613633
- Sponsor's protocol ID
- 2018-NSCLCSIB
- Status last verified
- Feb 2026
- First submitted
- 23 Sep 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Failure and Feasibility of Consolidative Stereotactic Radiotherapy in Third-generation EGFR-TKI-treated Metastatic EGFR-mutant Non-small Cell Lung Cancer: A Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT06613633
- Acronym / sponsor ID
- 2018-NSCLCSIB
- Keywords
- NSCLC, EGFR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Chest Hospital, Wuhan TongJi Hospital
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 26 Sep 2024 (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.
The goal of this observational study is to explore the feasibility of stereotactic radiotherapy (SRT) as consolidation therapy for patients with advanced non-small-cell lung cancer who were treated with third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). The investigators plan to explore the time to achieve the best response after EGFR-TKI treatment, the characteristics of the distribution of lesions when the best response is achieved, the feasibility of SRT when the best response is achieved, and the phenotype of disease progression after EGFR-TKI resistance.
In summary, this study will provide critical information for exploring the feasibility and optimal design of SRT as consolidation therapy for advanced NSCLC patients treated with third-generation EGFR-TKI, which will further promote the optimization of comprehensive treatment for EGFR-mutant advanced NSCLC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| third-generation EGFR-TKI monotherapy | – | Drug: third-generation EGFR-TKI (Osimertinib, Almonertinib or Furmonertinib) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced EGFR-mutant NSCLC patients receiving third-generation EGFR-TKIs are enrolled
Key inclusion criteria (9 listed)
- Pathologically confirmed non-small cell lung cancer;
- clinical stage IV (AJCC, 8th edition, 2017);
- EGFR sensitizing mutations (L858R or 19del);
- age≥18 years old;
- KPS score≥70;
Key exclusion criteria (11 listed)
- Multiple primary or metastatic tumors (except early skin cancer, cervical carcinoma in situ that has been treated radically, with no recurrence or progression for more than 5 years);
- Pregnant or lactating women who, as judged by the investigator, were not candidates for brain MRI;
- Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the signing of the informed consent form or affect patient compliance.;
- patients without EGFR sensitive mutations or with unknown EGFR mutation status.
- Withdrawal criteria
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-TKI (Osimertinib, Almonertinib or Furmonertinib)Patients with advanced EGFR-mutated NSCLC who met the inclusion criteria and received third-generation EGFR-TKI (monotherapy or combined with brain radiotherapy) | Drug | third-generation EGFR-TKI monotherapy |
Primary outcome
Time to Best Response
Time frame: 5 years
The time from the first day of third-generation EGFR-TKI treatment to the point at which the smallest tumor burden is observed on imaging studies.
2 secondary outcomes
Distribution of Tumor Lesions at Best Response
Time frame: 5 years
Phenotypes of Disease Progression After Third-Generation EGFR-TKI Resistance
Time frame: 5 years
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 29 Apr 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Third-generation TKI and NSCLC (Advanced Non-small Cell Lung Cancer), run by Fudan University at 3 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 9 inclusion and 11 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 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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?
Time to Best Response (time frame: 5 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 29 Apr 2026.