Clinical trial · Interventional
SBRT/RT in Oligometastatic Stage IV NSCLC
SBRT/RT to All Sites of Disease After Three Months of First-line Systemic Chemotherapy in Oligometastatic Stage IV NSCLC Before Maintenance
NCT05647590CI-TRIAL-00073376unknownN/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)
The core hypothesis to be tested is that the use of consolidative SBRT followed by maintenance chemotherapy in patients with less than or equal to 10 metastatic sites will improve progression-free survival (PFS) with acceptable toxicity compared to maintenance chemotherapy alone.
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 | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Procedure | — | UNRESOLVED |
| Maintenance chemotherapy | Procedure | — | UNRESOLVED |
| Radiotherapy (RT) + Stereotactic Body Ratio Therapy (SBRT) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NSCLC patients
- description
- Patients with non-small cell lung cancer (NSCLC) will be enrolled in the study.
- interventionNames
- Procedure: Chemotherapy
- Procedure: Radiotherapy (RT) + Stereotactic Body Ratio Therapy (SBRT)
- Procedure: Maintenance chemotherapy
Primary outcomes (2)
- measure
- Grade of Toxicity
- timeFrame
- up to 12 months
- description
- Grade of toxicity of the treatment will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4
- measure
- Progression-Free Survival
- timeFrame
- up to 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have biopsy-proven metastatic NSCLC (Stage IV). * Patients must have received three months of first-line chemotherapy and achieved stable disease or partial response. * Age ≥ 18 years * Patients must have measurable disease at baseline. * Patients can have up to 10 discrete active extracranial/intracranial lesions identified by PET/CT or MRI scan within 8 weeks prior to the initiation of SBRT. * Patients must have a Karnofsky Performance Scale (KPS) \>60 * AST, ALT \& Alkaline phosphates must be ≤ 2.5x the upper limit of normal. Total bilirubin must be within the limit of normal. * Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm³. * Patients should have adequate renal function (serum creatinine ≤1.5 times the upper limit of normal (ULN). * Females of childbearing potential should have a negative pregnancy test. * Patients who would be receiving SBRT for lung tumors must have a documented forced expiratory volume in 1 second (FEV1) ≥ 1L. * Patients must provide verbal and written informed consent to participate in the study Exclusion Criteria: * Patients receiving first-line erlotinib, gefitinib, or crizotinib for EGFR mutant-positive or EML4-ALK-positive NSCLC will be excluded. * Patients who previously received radiotherapy at the primary site with CT evidence of disease progression at the primary site within 3 months following the initial radiotherapy * Patients with serious, uncontrolled, concurrent infection(s) * Significant weight loss (\>10%) in the prior 3 months * Patients with cutaneous metastasis of NSCLC * Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cancers * Patients with more than 10 discrete extra/intracranial lesions * Participation in any investigational drug study within 4 weeks preceding the start of study treatment * Unwillingness to participate or inability to comply with the protocol for the duration of the study * Patients who are pregnant; patients with reproductive capability will need to use adequate contraception during the time of participation in the study
References
Publications (0)
Data not yet available
No reference posted for this study.