Addition of Radiotherapy to Standard Medical Treatment for Stage IV NSCLC

  • STATUS
    Recruiting
  • End date
    Feb 1, 2026
  • participants needed
    162
  • sponsor
    Swedish Lung Cancer Study Group
Updated on 24 January 2021
platelet count
cancer
lung cancer
metastasis
brain metastases
cancer chemotherapy
stage iv non-small cell lung cancer
lung carcinoma

Summary

The hypothesis for this study is that addition of a moderate dose of radiotherapy to the primary tumor and mediastinal nodes after three months of medical treatment could reduce the tumor burden, partly as an abscopal effect, and thereby improving quality of life and possible also prolonging survival for stage IV NSCLC.

Description

Primary objective: To assess whether the addition of radiotherapy to the remaining thoracic tumor burden following standard medical treatment results in a superior quality of life measured with lung cancer symptom scale (LCSS) in patients with stage IV non-small cell lung cancer. The comparison will be made at three months after randomization.

Secondary objectives: Overall survival, progression-free survival, toxicity and longitudinal quality of life measurements.

Design: Multicentre, randomized, phase III trial. Patients will be registered for the study up-front but randomization will be performed after evaluation of response, three months after initiating medical treatment with chemotherapy/ chemo-immunotherapy or immunotherapy. Randomization will be to thoracic radiotherapy or follow-up (1:1).

Details
Condition Non-Small Cell Lung Cancer, Radiation Oncology, Radiotherapy, radiotherapeutic, Quality of life, Stage IV Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, nsclc, quality-of-life, Stage IV Non-small Cell Lung Cancer
Treatment Thoracic radiotherapy
Clinical Study IdentifierNCT04530708
SponsorSwedish Lung Cancer Study Group
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histological or cytological confirmed non-small cell lung cancer (NSCLC)
Stage IV disease
Previously untreated disease (before first line treatment)
No symptomatic brain metastases
Performance status (WHO) 0-2
FEV1 (forced expiratory volume one second) 1 L or >40% of predicted
Written informed consent
Life expectancy 12 weeks
Platelet count 100,00/mm3
Hemoglobin 10 g/dl
WBC (White blod cells) 3,000/mm3
Kidney function allowing chemotherapy
Patients scheduled for standard platinum based chemotherapy, chemo-immunotherapy or immunotherapy
Willing and able to comply with study treatment

Exclusion Criteria

Requirement for daily supplemental oxygen
Second primary malignancy within 3 years, except for any of the following which can be included even if diagnosed within the past 3 years: Carcinoma in situ of the cervix, nonmelanoma skin cancer, history of low-grade (Gleason score 6) localized prostate cancer, definitely treated stage I breast cancer, other malignancy that was diagnosed and definitely treated 3 years ago with no subsequent evidence of recurrence
Concurrent severe and/or uncontrolled medical condition, including any of the
following
Angina pectoris
Congestive heart failure within the past 3 months, unless LVEF (left ventricular ejection fraction) > 40%
Myocardial infarction within the past 6 months
Clinically significant infection
Psychiatric illness or social situation that would limit compliance with study requirements
EGFR (epidermal growth factor receptor) mutation or ALK (anaplastic lymphoma kinas) - rearrangement detected
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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