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NCT Number: NCT04405401

Stereotactic Ablative Radiotherapy for Oligo-Progressive Non Small Cell Lung Cancer

A registry-based randomized screening phase II trial. A total of 68 patients with metastatic non small cell lung cancer on systemic therapy with oligoprogression to 1-5 extracranial lesions will be randomized using a 1:1 ratio to standard of care (begin next-line systemic therapy, best supportive care, continue current systemic line, based on treating physician decision) vs. receive stereotactic ablative radiotherapy to all oligoprogressive lesions while continuing their current systemic therapy.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Lung Cancer Metastatic Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3E4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Metastatic NSCLC enrolled in our CRCHUM Lung Cancer Registry and co-enrolled to the PERa registry
  • Ability to provide written informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-3
  • Oligoprogression to 1-5 extracranial lesions ≤ 5cm and involving ≤ 3 organs. Progression at the primary tumor site should be counted within the total of 5 lesions. For patients with lymph node metastases, each node is counted as one site of metastasis.
  • Oligoprogression while on ICI or TKI (any line)
  • Patients with brain metastasis are allowed; brain metastasis are not counted in the maximum number of lesions and should be treated as per standard of care
  • All sites of disease can, in the opinion of the investigator, be safely treated and targetable with SABR (taking into account prior local therapy, organ function and underlying medical condition such as inflammatory bowel disease, pulmonary fibrosis, etc.)
  • Patients with prior metastases that have been treated with ablative therapies (e.g. radiotherapy, surgery or radiofrequency ablation) before their current line of systemic therapy, are eligible.

Exclusion criteria

  • Any lesion beyond 5 cm
  • Pregnancy or breastfeeding
  • Any medical condition that could, in the opinion of the investigator, preclude radiotherapy or prevent follow-up after radiotherapy.
  • Presence of spinal cord compression Metastatic disease that invades the GI tract (including esophagus, stomach, small or large bowel)

Treatment and study plan

SABR

Radiation

SABR to all oligoprogressive lesions + continuation of current systemic therapy

Standard of care

Other

Patients on the standard arm will be treated as per standard of care in our institution. Treatment options could include switching to next systemic therapy line, best supportive care or continuing on current systemic therapy.

Primary outcomes

  1. PFS

    Time frame: 5 years

    PFS defined from randomization to disease progression at any site or death

  2. OS

    Time frame: 5 years

    OS defined as time from randomization to time of death from any cause.

Secondary outcomes

  1. Quality of life Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE)

    Time frame: 5 years

    Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE)

  2. Quality of life 5-level EQ-5D (EQ-5D-5L)

    Time frame: 5 years

    questionnaire

  3. Grade ≥ 3 toxicity

    Time frame: 5 years

    Measured using the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

  4. Local control

    Time frame: 5 years

    Defined as time from the end of SABR treatment to date of local failure and will be measured only in the experimental arm

  5. Time to next systemic therapy

    Time frame: 5 years

    Defined as time from randomization to time of subsequent therapy line

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Non Small Cell Lung Cancer: A Registry-based Phase II Randomized Trial

Acronym: SUPPRESS-NSCLC

Important dates

Study start
2021
Primary completion
2026
Study completion
2028
First posted
May 28, 2020
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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