Clinical trial · Interventional
Addition of Radiotherapy to Standard Medical Treatment for Stage IV NSCLC
Multicentre Phase III Study: Addition of Radiotherapy to Standard Medical Treatment for Stage IV NSCLC
NCT04530708CI-TRIAL-00046851MARSunknownN/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 hypothesis for this study is that addition of a moderate dose of radiotherapy to the primary tumor and mediastinal nodes after three months of medical treatment could reduce the tumor burden, partly as an abscopal effect, and thereby improving quality of life and possible also prolonging survival for stage IV NSCLC.
Conditions
Conditions (4)
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 |
| Quality of Life | — | UNRESOLVED | — |
| Radiotherapy | — | UNRESOLVED | — |
| Stage IV Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Thoracic radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- A: Standard of care
- description
- Normal standard of care and follow-up.
- type
- EXPERIMENTAL
- label
- B: Thoracic radiotherapy
- description
- Addition of thoracic radiotherapy to 36 Gy after medical treatment.
- interventionNames
- Radiation: Thoracic radiotherapy
Primary outcomes (1)
- measure
- Difference in quality of life
- timeFrame
- Three months after randomization
- description
- LCSS, lung cancer symptom scale. A scale from zero to one-hundred, higher number indicate worse symptoms.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological confirmed non-small cell lung cancer (NSCLC) * Stage IV disease * Previously untreated disease (before first line treatment) * No symptomatic brain metastases * Performance status (WHO) 0-2 * FEV1 (forced expiratory volume one second) ≥ 1 L or \>40% of predicted * Written informed consent * Life expectancy ≥ 12 weeks * Platelet count ≥ 100,00/mm3 * Hemoglobin ≥ 10 g/dl * WBC (White blod cells) ≥ 3,000/mm3 * Kidney function allowing chemotherapy * Patients scheduled for standard platinum based chemotherapy, chemo-immunotherapy or immunotherapy * Willing and able to comply with study treatment Exclusion Criteria: * Requirement for daily supplemental oxygen * Second primary malignancy within 3 years, except for any of the following which can be included even if diagnosed within the past 3 years: Carcinoma in situ of the cervix, nonmelanoma skin cancer, history of low-grade (Gleason score ≤ 6) localized prostate cancer, definitely treated stage I breast cancer, other malignancy that was diagnosed and definitely treated ≥ 3 years ago with no subsequent evidence of recurrence * Concurrent severe and/or uncontrolled medical condition, including any of the following: * Angina pectoris * Congestive heart failure within the past 3 months, unless LVEF (left ventricular ejection fraction) \> 40% * Myocardial infarction within the past 6 months * Clinically significant infection * Psychiatric illness or social situation that would limit compliance with study requirements * EGFR (epidermal growth factor receptor) mutation or ALK (anaplastic lymphoma kinas) - rearrangement detected
References
Publications (0)
Data not yet available
No reference posted for this study.