Clinical trial · Interventional
TKI Followed by Thoracic Radiotherapy for Stage IV EGFR Mutant NSCLC
Tyrosine Kinase Inhibitor Followed by Thoracic Radiotherapy for Stage IV EGFR Mutant Non-small Cell Lung Cancer: A Phase II Clinical Trial
NCT03916913CI-TRIAL-00038205unknownN/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)
In this phase II trial with single arm, we aim to investigate the clinical efficacy and toxicity profile of local radiotherapy on all disease sites for EGFR-mutant oligo-metastatic NSCLC (no more than 3 metastatic lesions) who did not experience disease progression after at least 3 months of TKI therapy.
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 |
|---|---|---|---|
| Non-Small Cell Lung Cancer Metastatic | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Local radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Local therapy
- description
- Consolidation local radiotherapy
- interventionNames
- Radiation: Local radiation therapy
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- 1 year
- description
- Duration between the first date of TKI administration and disease progression or last follow-up
Secondary outcomes (6)
- measure
- Overall response
- timeFrame
- 1 month after RT
- description
- Post-RT response compared with the baseline status at the first data of TKI administration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 and ≤75; * ECOG performance status 0-1; * Patients must provide study specific informed consent prior to study entry; * Pathologically or cytologically diagnosed as NSCLC; * EGFR activating mutation to TKI approved by histology, cytology or circulation tumor DNA; * Stage IV NSCLC with ≤ 3 metastatic lesions (AJCC, 8th ed.) confirmed by meticulous radiographic examination. Brain MRI and 18F PET/CT is strongly recommended unless there is a contraindication; * Patients have received≥3 months of TKI therapy and do not received disease progression; * HB ≥ 10.0 g/dL; * Absolute number of neutrophil granulocyte ≥ 1.5 × 109/L; * Absolute number of PLT ≥ 100 × 109/L; * Total bilirubin ≤ 1.5 folds of the maximum extent; * ALT and AST ≤ 2.0 folds of the maximum extent; * Cr ≤ 1.25 folds of the maximum extent and Ccr ≥ 60mLl/min. Exclusion Criteria: * Patients have received thoracic radiotherapy before; * Malignant pleural effusion, pericardial effusion or peritoneal effusion; * Patients have severe pulmonary comorbidity, such as ILD, COPD or other active pulmonary disease; * Any unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, CHF (NYHA ≥ II), MI within 6 months of enrollment, severe arrhythmia requiring medication,hepatic, nephric or metabolic disease; * HIV infection; * Pregnancy or lactation women; * ECOG status ≥2; * Mixed SCLC component; * Other factors that is considered ineligible.
References
Publications (0)
Data not yet available
No reference posted for this study.