Clinical trial · Interventional
SBRT Combined With Osimertinib Compared With Osimertinib for Stage IV NSCLC
Effect of SBRT Combined With Osimertinib Compared With Osimertinib Alone for Stage IV Non-small Cell Lung Cancer
NCT05583409CI-TRIAL-00061490unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Prospective, Multicenter, Randomized Controlled study to evaluate Stereotactic Body Radiation Therapy (SBRT) as a potential treatment for stage IV non-small cell lung cancer (NSCLC) that has a mutated epidermal growth factor receptor (EGFR) and has been receiving treatment with Osimertinib
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IV Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Osimertinib 80 MG | Drug | Osimertinib | ALIAS |
| SBRT+Osimertinib | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Osimertinib plus SBRT
- description
- SBRT with photon and dose is 40Gy/5F after three months after Osimertinib treatment
- interventionNames
- Radiation: SBRT+Osimertinib
- type
- ACTIVE_COMPARATOR
- label
- Osimertinib
- description
- Osimertinib 80mg, po, Qd
- interventionNames
- Drug: Osimertinib 80 MG
Primary outcomes (1)
- measure
- PFS
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have biopsy proven metastatic NSCLC (Stage IV). 2. Patients receiving first-line Osimertinib for EGFR mutant-positive for 3 months and achieved stable disease or partial response. 3. Age 18 to 75 years old. 4. Patients must have measurable disease at baseline. 5. The amount of metastatic focus \<5. 6. ECOG score 0-2 7 Adequate normal organ and marrow function for TKI treatment and radiotherapy. 8\. Patients must has sensitizing EGFR mutation (e.g. exon 19 deletion or exon 21 L858R) 9. Patients must provide written informed consent to participate in the study. Exclusion Criteria: 1. Patients who previously received radiotherapy to the primary site. 2. Patient can't tolerate radiotherapy or targeted therapy; 3. Pregnant or nursing women
References
Publications (0)
Data not yet available
No reference posted for this study.