Stereotactic Ablative Radiotherapy for Oligo-Progressive Non Small Cell Lung Cancer (SUPPRESS-NSCLC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer Metastatic
• Intervention / Treatment: Radiation: SABR; Other: Standard of care

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Silvine Benth; Phone Number: 514-890-8254; Email: silvine.benth.chum@ssss.gouv.qc.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X 3E4
      • Recruiting
      • Centre Hospitalier de l'Université de Montréal
      • Contact: Diane Trudel; Phone Number: 514-890-8254; Email: diane.dt.trudel.chum@ssss.gouv.qc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of care; Switch to subsequent systemic therapy line, best supportive care or continue current systemic line	Radiation: SABR; SABR to all oligoprogressive lesions + continuation of current systemic therapy
Experimental: Experimental SABR arm; Definitive SABR to oligoprogressive lesions + continue current systemic therapy	Other: Standard of care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	PFS defined from randomization to disease progression at any site or death	5 years
OS	OS defined as time from randomization to time of death from any cause.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE)	Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE)	5 years
Quality of life 5-level EQ-5D (EQ-5D-5L)	questionnaire	5 years
Grade ≥ 3 toxicity	Measured using the Common Terminology Criteria for Adverse Events (CTCAE v5.0)	5 years
Local control	Defined as time from the end of SABR treatment to date of local failure and will be measured only in the experimental arm	5 years
Time to next systemic therapy	Defined as time from randomization to time of subsequent therapy line	5 years

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Study Chair: Bertrand Routy, MD PhD, Centre hospitalier de l'Universite de Montreal (CHUM); Study Chair: Houda Bahig, MD PhD, Centre hospitalier de l'Universite de Montreal (CHUM)

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2021
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: May 24, 2020
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Actual): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: non small cell lung cancer; oligoprogression; steretactic body radiotherapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 2021-9066

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