NCT07822984Not yet recruitingPhase 2
Consolidative Stereotactic Radiotherapy for Oligo-Residual Advanced EGFR-Mutant NSCLC After First-Line Third-Generation EGFR-TKI Plus Chemotherapy
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
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 374 (estimated)
- First submitted
- 7 Aug 2026
- Start date
- Oct 2026
- Primary completion date
- Sept 2030
- Lead sponsor
- Fudan University
- Diseases
- Lung cancer
- NCT number
- NCT07822984
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 374
- From Oct 2026 to the primary completion date, Sept 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- Residual lesions considered unsuitable for consolidative stereotactic radiotherapy after first-line third-generation EGFR-TKI plus chemotherapy.
Other
- Pregnancy or breastfeeding, or considered unsuitable by the investigator for PET/CT or brain MRI examination.
Who the study is looking for
- 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.
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.