Palliative Thoracic ImmunoRT

NCT03705806 | Active Not Recruiting

• 1 other identifier: 18-5327
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The trial is designed as a prospective observational single arm study investigating stage IV non-small cell lung cancer patients who are routinely treated with a PD-1 inhibitor for indications approved by Health Canada. All patients who are selected will be referred for palliative thoracic radiotherapy and treated with a standard dose prescription of 30 Gy in 10 fractions.

Conditions

Lung Cancer, Nonsmall Cell; Lung Cancer

Outcome Measures

Primary Outcomes (3)

• Rate of Radiation related toxicities

  rates of radiation-related toxicities in the combination of immunotherapy and palliative thoracic radiotherapy using CTCAE v5.0 grading

  up to 24 months

• Patient Report Outcome

  FACT-E

  up to 12 months

• Patient experience and anxiety related to Quality of Life

  EQ-5D

  up to 12 months

Secondary Outcomes (3)

• Rate of Survival

  1 year

• Rate of Survival

  2 year

• Rate of Disease Recurrence

  3, 6, 12 months

Interventions

Radiation combined with immunotherapy RADIATION

The trial is designed as a prospective observational single arm study investigating stage IV non-small cell lung cancer patients who are routinely treated with a PD-1 inhibitor for indications approved by Health Canada. All patients who are selected will be referred for palliative thoracic radiotherapy and treated with a standard dose prescription of 30 Gy in 10 fractions.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will include a population of patients with metastatic NSCLC on first or second line immunotherapy who have an indication for palliative thoracic radiation

You may qualify if:

• Pathologically confirmed AJCC 7th/8th edition Stage IV adenocarcinoma or squamous cell carcinoma not eligible for curative treatment.
• Indication and suitability to receive palliative radiotherapy to the thorax (30Gy/10).
• Receiving or planned to receive nivolumab or pembrolizumab
• Prior history of systemic chemotherapy is permitted given a washout period of 4 weeks
• Age 18 or older
• ECOG Performance Status 0-2
• Life expectancy greater than 3 months
• Able and willing to provide informed consent
• Able to complete patient reported outcome questionnaires

You may not qualify if:

• Contraindications to radiotherapy, including a history of SLE, systemic scleroderma, IPF, ataxia telangiectasia
• Previous history of thoracic radiotherapy with an overlapping field
• Previous history of checkpoint inhibitor related pneumonitis or esophagitis
• Pregnancy

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Study procedures include blood draw at baseline, end of radiation treatment, and at 1 month follow up visit.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: October 15, 2018
• Study Start: October 3, 2018
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)