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NCT Number: NCT03705806

Palliative Thoracic ImmunoRT

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Lung Cancer, Nonsmall Cell Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Cancer 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

Observational

Primary location

University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Rate of Radiation related toxicities

    Time frame: up to 24 months

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

  2. Patient Report Outcome

    Time frame: up to 12 months

    FACT-E

  3. Patient experience and anxiety related to Quality of Life

    Time frame: up to 12 months

    EQ-5D

Secondary outcomes

  1. Rate of Survival

    Time frame: 1 year

  2. Rate of Survival

    Time frame: 2 year

  3. Rate of Disease Recurrence

    Time frame: 3, 6, 12 months

    Patients will be followed for up to two years following the completion of their radiotherapy. They will undergo CT surveillance imaging as standard by routine immunotherapy protocol with a minimum of 3 scans at the 3, 6 and 12 month mark. Local and distant recurrence will be determined primarily by CTCAE with CT scans as per ir-RECIST v1.0 criteria.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Evaluation of Toxicities With Thoracic Radiotherapy and Immune Checkpoint Inhibition in Non-small Cell Lung Cancer

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Oct 15, 2018
Registry last updated
Mar 4, 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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