Actively Recruiting
Addition of Hypofractionated High Dose Radiation in Oligometastatic Disease
Led by Vastra Gotaland Region · Updated on 2026-04-14
240
Participants Needed
6
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a 2:1 randomized multicentre open label phase III study of radiation combined with standard systemic treatment compared with systemic treatment alone in oligometastatic (≤5 metastases) NSCLC. Stratification factors: performance status, gender and systemic strategy. The systemic treatment consists of chemotherapy/chemoimmunotherapy or immunotherapy and is given according to local practice. During the first 3 months of systemic treatment, aiming to start around the 2nd cycle is radiotherapy delivered to all known lesions. Preferably with SBRT /SRT/SRS but conventional radiotherapy may also be used. After the first three cycles of systemic treatment, the patients are assessed, and after four cycles, they are continuing maintenance therapy if indicated. The patients are followed with radiology every three months.
CONDITIONS
Official Title
Addition of Hypofractionated High Dose Radiation in Oligometastatic Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained prior to any study procedures
- Histological or cytological diagnosis of non-small cell lung cancer (NSCLC)
- Stage IV disease with five or fewer metastases (excluding primary tumor or mediastinal nodes)
- Patient fit for first-line chemoimmunotherapy, immunotherapy, or chemotherapy
- Extra-thoracic metastases accessible for stereotactic body radiotherapy (SBRT)
- Thoracic tumors accessible for SBRT or conventional radiotherapy
- No prior systemic treatment or radiation therapy for NSCLC (previous adjuvant therapy allowed)
- Age over 18 years at study entry, no upper age limit
- WHO performance status 0-2
- Adequate organ and marrow function
- Post-menopausal status or negative pregnancy test for female pre-menopausal subjects
- Willingness and ability to comply with study protocol and visits
You will not qualify if you...
- Solitary brain lesion or contralateral lung lesion as the only distant metastasis
- Participation in another clinical study with an investigational product within last 4 weeks
- Presence of EGFR+, ALK+, ROS1+ disease or other genetic alterations requiring TKI first-line treatment
- Malignant pleural fluid, ascites, or excessive fluid interfering with radiation
- Leptomeningeal disease
- Pulmonary fibrosis making treatment unsafe
- Not fit for standard first-line systemic therapy
- Second primary residual malignancy or recent malignancy relapse
- Pregnant or breastfeeding females, or unwillingness to use effective birth control
- Any other condition interfering with treatment evaluation or patient safety
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Dept of Oncology
Gothenburg, Sweden, 41345
Actively Recruiting
2
Dept of pulmonary medicine
Linköping, Sweden
Not Yet Recruiting
3
Dept of pulmonary medicine
Lund, Sweden
Not Yet Recruiting
4
Dept of Oncology
Stockholm, Sweden
Actively Recruiting
5
Dept. of Oncology
Umeå, Sweden
Actively Recruiting
6
Dept. of Oncology
Uppsala, Sweden
Actively Recruiting
Research Team
A
Andreas Hallqvist
CONTACT
M
Marielle Drousiotis
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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