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Palliative RadIotherapy of Multiple Metastatic Sites Before First Line of Systemic Therapy With Immune Checkpoint Inhibitors and Chemotherapy in Metastatic Non-Small-Cell Lung Cancer

NCT05440916 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-02

No results posted yet for this study

Summary

The study is designed as a non-randomized Phase 2 clinical intervention study. The study will include patients with disseminated Non-Small Cell Lung Carcinoma (NSCLC) which are eligible for first line of systemic treatment with immune checkpoint inhibitors and platinum-based chemotherapy (PDL1 less than 50%). Patients will receive palliative radiotherapy to multiple sites (2 to 5 sites) prior to systemic treatment.

Results of treatment will be compared to historical cohort of patients treated only with systemic therapy.

Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Metastatic Lung Non-Small Cell Carcinoma
  • Non Small Cell Lung Cancer

Interventions

RADIATION

Palliative Radiotherapy: 5 x 4Gy

Palliative irradiation of 2 to 5 sites (metastatic sites or/and primary lung tumour) in one week before systemic therapy. Systemic therapy should be given as soon as possible after irradiation.

DRUG

chemotherapy + immune checkpoint inhibitors

Systemic therapy according to national/European recommendations.

Sponsors & Collaborators

  • Institute of Oncology Ljubljana

    collaborator OTHER

  • The University Clinic of Pulmonary and Allergic Diseases Golnik

    collaborator OTHER

  • University Medical Centre Maribor

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-14
Primary Completion
2025-01-13
Completion
2025-09-01

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05440916 on ClinicalTrials.gov