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Addition of Hypofractionated High Dose Radiation in Oligometastatic Disease | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE3

Addition of Hypofractionated High Dose Radiation in Oligometastatic Disease

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

NCT06141070•Vastra Gotaland Region

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

Exclusion Criteria

•• 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

Locations (6)

Dept of Oncology

Gothenburg, Sweden

Dept of pulmonary medicine

Linköping, Sweden

Dept of pulmonary medicine

Lund, Sweden

Dept of Oncology

Stockholm, Sweden

Dept. of Oncology

Umeå, Sweden

Dept. of Oncology

Uppsala, Sweden

Key Dates

Start Date

December 1, 2023

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2027

Last Updated

November 21, 2023

Enrollment

240

ESTIMATED participants

Conditions

Non Small Cell Lung Cancer

Interventions

Standard systemic therapy + radiotherapy

OTHER

Standard systemic therapy

DRUG

Contacts

Andreas Hallqvist

CONTACT

+46313427954 andreas.hallqvist@vgregion.se

Marielle Drousiotis

CONTACT

+46313424509 marielle.drousiotis@vgregion.se

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Addition of Hypofractionated High Dose Radiation in Oligometastatic Disease

Inclusion Criteria

Exclusion Criteria

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