Addition of Hypofractionated High Dose Radiation in Oligometastatic Disease

NCT ID: NCT06141070

Last Updated: 2023-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2027-12-01

Brief 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.

Conditions

Non Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A, standard systemic therapy

Standard systemic chemoimmunotherapy

Group Type: ACTIVE_COMPARATOR

Standard systemic therapy

Intervention Type: DRUG

Chemoimmunotherapy or immunotherapy

B, Radiotherapy + systemic therapy

Standard systemic chemoimmunotherapy and radiation to all known lesions

Group Type: EXPERIMENTAL

Standard systemic therapy + radiotherapy

Intervention Type: OTHER

Combined systemic therapy + radiation

Interventions

Standard systemic therapy + radiotherapy

Combined systemic therapy + radiation

Intervention Type: OTHER

Standard systemic therapy

Chemoimmunotherapy or immunotherapy

Intervention Type: DRUG

Eligibility Criteria

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.

• 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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

Sweden

Central Contacts

Andreas Hallqvist

Role: CONTACT

andreas.hallqvist@vgregion.se

+46313427954

Marielle Drousiotis

Role: CONTACT

marielle.drousiotis@vgregion.se

+46313424509

Other Identifiers

The ANDROMEDA trial

Identifier Type: -

Identifier Source: org_study_id