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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University Medical Centre Maribor
With
Institute of Oncology Ljubljana
The University Clinic of Pulmonary and Allergic Diseases Golnik
The primary objective is to investigate efficacy of radiation therapy before the first line of systemic therapy with immune checkpoint inhibitors and platinum-based chemotherapy in metastatic NSCLC (PDL1 less than 50%).
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed consent to the study before the start of the procedures related to the protocol
Age ≥ 18 years at time of study entry
ECOG performance status 0-2
Histologically or cytologically confirmed non-small cell lung cancer, with expression of PD-L1 of less than 50%
Stage IV metastatic Non-Small Cell Cancer confirmed by CT scan (of brain, chest and abdomen) or PET CT
Patients must be eligible for first line of systemic treatment with standard of care checkpoint inhibitor immune therapy and chemotherapy - according to the recommendations
inclusion of patients treated for few brain metastases (with surgery or ablative radiosurgery) is permitted (if the disease in the central nervous system is under control)
Prior surgery (diagnostic and therapeutic) and irradiation (for example: stereotactic irradiation of brain metastases) is permitted, provided that patients have fully recovered from the procedure at least 2 weeks before inclusion in the study
Patients treated with surgery or radiation and chemotherapy for limited non-small cell carcinoma in the past is permitted
You may not be if
Metastatic non-small cell carcinoma with known oncogenic alterations suitable for targeted treatment
Brain or meningeal metastases that are not under control
Other malignancy (other than non-small cell carcinoma) present that has progressed and/or requires active treatment
Previous malignancy, unless cured or complete remission has been achieved for at least 2 years prior to enrolment and does not require maintenance treatment. With the exception of basal cell carcinoma or squamous cell carcinoma of skin, which was treated and precancerous diseases and in situ cancers
Patients with interstitial lung disease
The possibility of radical treatment of oligometastatic disease (primary tumour and metastases)
Previous treatment with anti PD-1, anti PD-L1, anti CTLA-4 antibodies, or any other treatment that affects T lymphocytes or checkpoint pathways
Patients with known sensitivity to monoclonal antibodies
Patients with known HIV infection
Patients with active or chronic hepatitis B and / or C
Pregnant and breastfeeding mothers
Patients with serious and uncontrollable health problems (physical and mental), which, according to researchers, could affect the poor participation of patients and make it difficult to interpret the results
Patients on corticosteroid therapy (more than 10 mg methylprednisolone or equivalent) prior to enrolment
Irradiation 2 months before inclusion in the study, except for stereotactic irradiation of brain metastases (or radiation and chemotherapy for limited non-small cell carcinoma in the past)
Clareo Health | 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
