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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A, standard systemic therapy | Active Comparator | Standard systemic chemoimmunotherapy |
|
| B, Radiotherapy + systemic therapy | Experimental | Standard systemic chemoimmunotherapy and radiation to all known lesions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard systemic therapy + radiotherapy | Other | Combined systemic therapy + radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Time to death | From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Time to progressive disease or death | From date of randomization until the date of first documented systemic progression or date of death from any cause, whichever came first, assessed up to 60 months |
| Local control (LC) |
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Inclusion Criteria:
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.
Exclusion Criteria:
• Solitary brain lesion or contralateral lung lesion as the only distant metastasis
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andreas Hallqvist | Contact | +46313427954 | andreas.hallqvist@vgregion.se | |
| Marielle Drousiotis | Contact | +46313424509 | marielle.drousiotis@vgregion.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Oncology | Recruiting | Gothenburg | 41345 | Sweden |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Standard systemic therapy | Drug | Chemoimmunotherapy or immunotherapy |
|
Percentage complete, partial remission or stable disease |
| At 12 months after randomization |
| Dept of pulmonary medicine | Not yet recruiting | Linköping | Sweden |
|
| Dept of pulmonary medicine | Not yet recruiting | Lund | Sweden |
|
| Dept of Oncology | Recruiting | Stockholm | Sweden |
|
| Dept. of Oncology | Recruiting | Umeå | Sweden |
|
| Dept. of Oncology | Recruiting | Uppsala | Sweden |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |