Clinical trial · Interventional
A Study of Hypofractionated Radiotherapy for Limited Metastatic NSCLC Harboring Sensitizing EGFR Mutations After First Line TKI Therapy
A Phase II Trial of Hypofractionated Radiotherapy for Limited Metastatic NSCLC Harboring Sensitizing EGFR Mutations After First Line TKI Therapy
NCT02788058CI-TRIAL-00022453unknownPhase 2ClinicalTrials.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)
To evaluate the efficacy and toxicity of patients treated with hypofractionated radiotherapy for limited metastatic NSCLC harboring sensitizing EGFR mutations after first line TKI therapy. An exploratory biomarker analysis in blood and tumor samples is also planned.
Conditions
Conditions (2)
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 Positive Non-small Cell Lung Cancer | — | UNRESOLVED | — |
| Lung Adenocarcinoma | Lung Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EGFR-TKI | Drug | — | UNRESOLVED |
| Thoracic Hypofractionated Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- EGFR-TKI
- description
- Patients take EGFR-TKI alone till tumor progression
- interventionNames
- Drug: EGFR-TKI
- type
- ACTIVE_COMPARATOR
- label
- EGFR-TKI+hypofractionated radiotherapy
- description
- After 3 mos TKI, patients with limited metastatic take EGFR-TKI concurrent with hypofractionated radiotherapy till tumor progression.
- interventionNames
- Drug: EGFR-TKI
- Radiation: Thoracic Hypofractionated Radiotherapy
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed metastatic lung adenocarcinoma harboring sensitizing EGFR mutations (L858R, exon 19 deletion), and became oligometastatic disease after 3 months TKI, evaluated by PET/CT scan, brain MRI, and abdomen ultrasound (≤6 discrete lesions of disease, exclusive of the brain metastases, ≤3 lesions in the liver, ≤3 lesions in the lung); * All sites of disease must be amenable to definitive RT; * An intrathoracic lymph nodal station is considered 1 discrete lesion, according to IASLC lymph nodal station map; * Age 18 years or older; * ECOG Performance Status 0-2; * Adequate bone marrow, liver and renal function, as specified below: Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L; Hemoglobin ≥ 8 g/dL; Platelets ≥ 100 x 109/L; Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) ; AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present; Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal; * For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment; * Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter; * Patients and their family signed the informed consents; Exclusion Criteria: * Received chemotherapy before TKI therapy; * Brain parenchyma or leptomeningeal disease; * Any site of disease that is not amenable to definitive RT; * Concurrent malignancies other than non-melanoma skin cancer that require active ongoing treatment; * Any medical co-morbidities that would preclude radiation therapy.
References
Publications (0)
Data not yet available
No reference posted for this study.