EGFR-mutant Non-small Cell Lung CancerPhase 2NCT07822984
Consolidative Stereotactic Radiotherapy for Oligo-Residual Advanced EGFR-Mutant NSCLC After First-Line Third-Generation EGFR-TKI Plus Chemotherapy
A Phase 2 study testing Third-generation EGFR tyrosine kinase inhibitor, Platinum plus pemetrexed chemotherapy and Pemetrexed maintenance therapy in people with EGFR-mutant Non-small Cell Lung Cancer and SBRT, run by Fudan University.
Trial summary
This national multicenter, randomized controlled clinical trial evaluates the safety and efficacy of consolidative stereotactic radiotherapy in patients with advanced EGFR-mutant non-small cell lung cancer who have oligo-residual disease after four cycles of first-line treatment with third-generation EGFR-TKI plus… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- EGFR-mutant Non-small Cell Lung Cancer, SBRT, NSCLC (Advanced Non-small Cell Lung Cancer)
- What is being tested?
- Third-generation EGFR tyrosine kinase inhibitor, Platinum plus pemetrexed chemotherapy and Pemetrexed maintenance therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Sep 2030
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed non-small cell lung cancer.
- Clinical stage IV disease according to the AJCC 9th edition.
- Sensitizing EGFR mutation: EGFR exon 19 deletion or EGFR L858R.
- Age 18-75 years.
- Karnofsky Performance Status score ≥70.
- Complete whole-body imaging assessment before initiation of first-line third-generation EGFR-TKI plus chemotherapy, with at least one evaluable lesion according to RECIST version 1.1.
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- No disease progression after completion of four cycles of first-line third-generation EGFR-TKI plus chemotherapy and no unresolved grade ≥3 nonhematologic toxicity.
- Oligo-residual disease after four treatment cycles, with all residual lesions considered suitable for stereotactic radiotherapy by the investigator.
- Written informed consent.
Who cannot join
- Double primary or multiple primary malignancies, except early skin cancer or cervical carcinoma in situ treated with curative intent and without recurrence or progression for at least five years.
- Pregnancy or breastfeeding, or considered unsuitable by the investigator for PET/CT or brain MRI examination.
- History of uncontrolled epilepsy, central nervous system disease, or psychiatric disorder that, in the investigator's judgment, may interfere with informed consent or participant compliance.
- Residual lesions considered unsuitable for consolidative stereotactic radiotherapy after first-line third-generation EGFR-TKI plus chemotherapy.
About this study
Official title: Consolidative Stereotactic Radiotherapy for Oligo-Residual Advanced EGFR-Mutant Non-Small Cell Lung Cancer After First-Line Treatment With Third-Generation EGFR Tyrosine Kinase Inhibitor Plus Chemotherapy: A National Multicenter, Randomized Controlled Clinical Trial
This national multicenter, randomized controlled clinical trial evaluates the safety and efficacy of consolidative stereotactic radiotherapy in patients with advanced EGFR-mutant non-small cell lung cancer who have oligo-residual disease after four cycles of first-line treatment with third-generation EGFR-TKI plus platinum-based pemetrexed chemotherapy. Eligible participants will be randomized 1:1 to continue third-generation EGFR-TKI plus pemetrexed maintenance therapy alone or to receive stereotactic radiotherapy to all oligo-residual lesions in addition to the same maintenance therapy. The primary endpoint is progression-free survival.
- Being tested
- Third-generation EGFR tyrosine kinase inhibitor, Platinum plus pemetrexed chemotherapy, Pemetrexed maintenance therapy, Consolidative stereotactic radiotherapy
- Keywords
- NSCLC, EGFR, TKI, Radiotherapy
- 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 tyrosine kinase inhibitorDrug
administered during induction and maintenance; the specific third-generation EGFR-TKI is not uniformly restricted in the protocol.
Platinum plus pemetrexed chemotherapyDrug
cisplatin or carboplatin plus pemetrexed for four 3-week cycles during induction.
Pemetrexed maintenance therapyDrug
administered with the third-generation EGFR-TKI until disease progression or unacceptable toxicity.
Consolidative stereotactic radiotherapyRadiation
SRS/SRT/SBRT delivered to all eligible intracranial and/or extracranial oligo-residual lesions, completed as a single course or in staged courses within one month.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy plus TKI Group | Experimental | Consolidative stereotactic radiotherapy plus continued third-generation EGFR-TKI and pemetrexed maintenance therapy. Receives: Drug: Third-generation EGFR tyrosine kinase inhibitor; Drug: Platinum plus pemetrexed chemotherapy; Drug: Pemetrexed maintenance therapy; Radiation: Consolidative stereotactic radiotherapy |
| TKI alone Group | Active comparator | Continued third-generation EGFR-TKI and pemetrexed maintenance therapy alone. Receives: Drug: Third-generation EGFR tyrosine kinase inhibitor; Drug: Platinum plus pemetrexed chemotherapy; Drug: Pemetrexed maintenance therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
The time from randomization to disease progression or death of the patient. Patients who have not yet progressed at the time of analysis will be censored at the date of their last contact.
Measured: 4 years
Secondary outcomes (4)
Overall Survival (OS)
Measured: 4 years
Intracranial Progression-Free Survival (iPFS)
Measured: 4 years
Health-Related Quality of Life (HRQoL)
health-related quality of life assessed using the QLQ-C30 and QLQ-LC13 questionnaires
Measured: 4 years
Incidence of Treatment-Related Toxicities
proportion of evaluable participants experiencing treatment-related toxicities, graded according to CTCAE version
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR-mutant Non-small Cell Lung CancerStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 374 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhengfei Zhu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822984
- Sponsor's protocol ID
- LUNG-SORT2
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consolidative Stereotactic Radiotherapy for Oligo-Residual Advanced EGFR-Mutant Non-Small Cell Lung Cancer After First-Line Treatment With Third-Generation EGFR Tyrosine Kinase Inhibitor Plus Chemotherapy: A National Multicenter, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07822984
- Acronym / sponsor ID
- LUNG-SORT2
- Keywords
- NSCLC, EGFR, TKI, Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 374 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 16 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 national multicenter, randomized controlled clinical trial evaluates the safety and efficacy of consolidative stereotactic radiotherapy in patients with advanced EGFR-mutant non-small cell lung cancer who have oligo-residual disease after four cycles of first-line treatment with third-generation EGFR-TKI plus platinum-based pemetrexed chemotherapy. Eligible participants will be randomized 1:1 to continue third-generation EGFR-TKI plus pemetrexed maintenance therapy alone or to receive stereotactic radiotherapy to all oligo-residual lesions in addition to the same maintenance therapy. The primary endpoint is progression-free survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy plus TKI Group | Experimental | Drug: Third-generation EGFR tyrosine kinase inhibitor, Drug: Platinum plus pemetrexed chemotherapy, Drug: Pemetrexed maintenance therapy, Radiation: Consolidative stereotactic radiotherapyConsolidative stereotactic radiotherapy plus continued third-generation EGFR-TKI and pemetrexed maintenance therapy. |
| TKI alone Group | Active comparator | Drug: Third-generation EGFR tyrosine kinase inhibitor, Drug: Platinum plus pemetrexed chemotherapy, Drug: Pemetrexed maintenance therapyContinued third-generation EGFR-TKI and pemetrexed maintenance therapy alone. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed non-small cell lung cancer.
- Clinical stage IV disease according to the AJCC 9th edition.
- Sensitizing EGFR mutation: EGFR exon 19 deletion or EGFR L858R.
- Age 18-75 years.
- Karnofsky Performance Status score ≥70.
Key exclusion criteria (4 listed)
- Double primary or multiple primary malignancies, except early skin cancer or cervical carcinoma in situ treated with curative intent and without recurrence or progression for at least five years.
- Pregnancy or breastfeeding, or considered unsuitable by the investigator for PET/CT or brain MRI examination.
- History of uncontrolled epilepsy, central nervous system disease, or psychiatric disorder that, in the investigator's judgment, may interfere with informed consent or participant compliance.
- Residual lesions considered unsuitable for consolidative stereotactic radiotherapy after first-line third-generation EGFR-TKI plus chemotherapy.
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 tyrosine kinase inhibitoradministered during induction and maintenance; the specific third-generation EGFR-TKI is not uniformly restricted in the protocol. | Drug | Radiotherapy plus TKI Group, TKI alone Group |
| Platinum plus pemetrexed chemotherapycisplatin or carboplatin plus pemetrexed for four 3-week cycles during induction. | Drug | Radiotherapy plus TKI Group, TKI alone Group |
| Pemetrexed maintenance therapyadministered with the third-generation EGFR-TKI until disease progression or unacceptable toxicity. | Drug | Radiotherapy plus TKI Group, TKI alone Group |
| Consolidative stereotactic radiotherapySRS/SRT/SBRT delivered to all eligible intracranial and/or extracranial oligo-residual lesions, completed as a single course or in staged courses within one month. | Radiation | Radiotherapy plus TKI Group |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 4 years
The time from randomization to disease progression or death of the patient. Patients who have not yet progressed at the time of analysis will be censored at the date of their last contact.
4 secondary outcomes
Overall Survival (OS)
Time frame: 4 years
Intracranial Progression-Free Survival (iPFS)
Time frame: 4 years
Health-Related Quality of Life (HRQoL)
Time frame: 4 years
Incidence of Treatment-Related Toxicities
Time frame: 4 years
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 16 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Third-generation EGFR tyrosine kinase inhibitor, Platinum plus pemetrexed chemotherapy and Pemetrexed maintenance therapy in people with EGFR-mutant Non-small Cell Lung Cancer and SBRT, run by Fudan University.
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 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 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Progression-Free Survival (PFS) (time frame: 4 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 16 Sep 2026.