Radiation added to standard drug treatment for lung cancer that has spread a little
Tests radiation plus standard drug treatment against drugs alone in adults with lung cancer.
Plain-language title generated from the registry record
Registry title: Addition of Hypofractionated High Dose Radiation in Oligometastatic Disease
Key facts
- Where
- Gothenburg, Linköping, Lund, Stockholm, Umeå, and Uppsala, SwedenSee the 6 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with stage IV non-small cell lung cancer and 5 or fewer metastases who have not yet had treatment for it. It compares radiation plus standard drug treatment with drug treatment alone.
- Age
- Over 18 years, no upper age limit.
- Sex
- All sexes can join.
- Disease stage
- Non-small cell lung cancer, stage IV, with 5 or fewer metastases (not counting the main tumour or lymph nodes in the chest). The metastases and chest tumours must be reachable by radiotherapy. WHO performance status 0-2.
- Earlier treatment
- No earlier drug treatment or radiation for this lung cancer. Earlier adjuvant drug treatment is allowed. The person must be fit for first-line chemotherapy, immunotherapy or both.
- Biomarker or test result
- Cannot join with EGFR+, ALK+, ROS1+ disease or another gene change that would lead to treatment with a TKI as first-line treatment.
Main reasons for not taking part
- A single brain lesion or a single lesion in the opposite lung as the only distant metastasis
- EGFR+, ALK+, ROS1+ or another gene change needing TKI first-line treatment
- Malignant fluid in the pleura or abdomen, or leptomeningeal disease
- Pulmonary fibrosis that makes the radiotherapy hazardous
- Pregnant or breastfeeding, or not willing to use effective birth control
Read by machine on 12 November 2026.
Where in Sweden
- Dept of OncologyGothenburg, SwedenContact: Andreas HallqvistTaking people
- Dept of pulmonary medicineLinköping, SwedenContact: Anders WikströmNot yet recruiting
- Dept of pulmonary medicineLund, SwedenContact: Maria Planck, Ass. prof.Not yet recruiting
- Dept of OncologyStockholm, SwedenContact: Karin Lindberg, PhDTaking people
- Dept. of OncologyUmeå, SwedenContact: Mikael Johansson, Ass. Prof.Taking people
- Dept. of OncologyUppsala, SwedenContact: Georg HolgerssonTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Vastra Gotaland Region
- Trial code
- NCT06141070
- Record updated
- 14 April 2026
- Original description
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.Read full original descriptionShow less
Addition of Hypofractionated High Dose Radiation in Oligometastatic Disease - An Open Label Randomized Phase III Trial Comparing Up-front Radiation in Oligometastatic Non-small Cell Lung Cancer (NSCLC) and Systemic Treatment With Systemic Treatment Alone
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.
Inclusion: Written informed consent obtained from the subject prior to performing any protocol- related procedures, including screening procedures; Histological or cytological diagnosis of NSCLC; Stage IV disease with ≤5 metastases (not including primary tumour or mediastinal nodes, N1-N3); Patient deemed fit for first line chemoimmunotherapy, immunotherapy or chemotherapy; Extra-thoracic metastases accessible for stereotactic body radiotherapy (SBRT); Thoracic tumour(s) accessible for SBRT or conventional radiotherapy; Received no prior systemic treatment or radiation therapy for NSCLC (previous adjuvant systemic therapy is allowed); Age > 18 years at time of study entry, no upper age limit; WHO performance status 0-2; Adequate normal organ and marrow function Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal subjects; Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Exclusion: • Solitary brain lesion or contralateral lung lesion as the only distant metastasis; Participation in another clinical study with an investigational product during the last 4 weeks; Patients with EGFR+, ALK+, ROS1+ disease or any other genetic alteration that would result in a TKI based first line treatment (i.e. first line treatment not being chemoimmuno- or immunotherapy); Malignant pleural fluid, or ascites (malignant cells or clinical judgement) or excessive fluid hampering radiation according to protocol; Leptomeningeal disease; Pulmonary fibrosis making protocol stipulated treatment hazardous (low grade radiologic findings are allowed as assessed by the investigator); Not deemed fit for standard first line systemic therapy; Second primary residual malignancy. Other malignancy diagnosed and treated > 2 years ago without relapse and deemed to have a low likelihood of relapse is allowed. (Carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin < 2 years are allowed, as is other low-grade malignancy with low likelihood of becoming metastatic or impact on survival e.g. low-grade prostate cancer not in need of treatment); Female subjects who are pregnant or breastfeeding or male or female subjects of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of systemic therapy; Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.