Clinical trial · Interventional
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
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EGFR-mutant Non-small Cell Lung Cancer | — | UNRESOLVED | — |
| NSCLC (Advanced Non-small Cell Lung Cancer) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
| SBRT | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Consolidative stereotactic radiotherapy | Radiation | — | UNRESOLVED |
| Pemetrexed maintenance therapy | Drug | — | UNRESOLVED |
| Platinum plus pemetrexed chemotherapy | Drug | — | UNRESOLVED |
| Third-generation EGFR tyrosine kinase inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radiotherapy plus TKI Group
- description
- Consolidative stereotactic radiotherapy plus continued third-generation EGFR-TKI and pemetrexed maintenance therapy.
- interventionNames
- Drug: Third-generation EGFR tyrosine kinase inhibitor
- Drug: Platinum plus pemetrexed chemotherapy
- Drug: Pemetrexed maintenance therapy
- Radiation: Consolidative stereotactic radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- TKI alone Group
- description
- Continued third-generation EGFR-TKI and pemetrexed maintenance therapy alone.
- interventionNames
- Drug: Third-generation EGFR tyrosine kinase inhibitor
- Drug: Platinum plus pemetrexed chemotherapy
- Drug: Pemetrexed maintenance therapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available