Addition of Hypofractionated High Dose Radiation in Oligometastatic Disease (ANDROMEDA)

April 13, 2026 updated by: Vastra Gotaland Region

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A, standard systemic therapy
Standard systemic chemoimmunotherapy
Drug: Standard systemic therapy
Chemoimmunotherapy or immunotherapy
Experimental: B, Radiotherapy + systemic therapy
Standard systemic chemoimmunotherapy and radiation to all known lesions
Other: Standard systemic therapy + radiotherapy
Combined systemic therapy + radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 months
Time to death
From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: 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
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)
Time Frame: At 12 months after randomization
Percentage complete, partial remission or stable disease
At 12 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

November 13, 2023

First Submitted That Met QC Criteria

November 17, 2023

First Posted (Actual)

November 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The ANDROMEDA trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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