Palliative radiotherapy before systemic treatment for metastatic lung cancer
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 (PRIMM Study)
This study is testing if giving radiation therapy to multiple spots in the body before starting treatment for metastatic lung cancer can help patients feel better and respond better to their cancer medications.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Centre Maribor Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (Golnik and 2 other locations) |
| Trial ID | NCT05440916 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of palliative radiotherapy administered to multiple metastatic sites in patients with metastatic Non-Small Cell Lung Carcinoma (NSCLC) prior to starting first-line systemic therapy with immune checkpoint inhibitors and platinum-based chemotherapy. The study is non-randomized and aims to include patients with a PD-L1 expression of less than 50%. Participants will receive radiation therapy to 2 to 5 metastatic sites, and the outcomes will be compared to a historical cohort that received only systemic therapy. The goal is to determine if this approach improves treatment efficacy for these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with stage IV metastatic Non-Small Cell Lung Cancer and a PD-L1 expression of less than 50% who are eligible for first-line systemic treatment.
Not a fit: Patients with a PD-L1 expression of 50% or greater, or those with uncontrolled central nervous system disease, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the effectiveness of systemic therapies in patients with metastatic lung cancer.
How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this novel intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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) * Patients who are not eligible for checkpoint immune inhibitor treatment due to contraindications such as autoimmune diseases, with the exception of some exceptions (Vitiligo; type I diabetes; hormone replacement hypothyroidism; psoriasis that does not require systemic treatment or other autoimmune diseases that do not limit checkpoint immune inhibitors treatment) * 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)
Where this trial is running
Golnik and 2 other locations
- University Clinic Golnik — Golnik, Slovenia (Recruiting)
- Institute of Oncology Ljubljana — Ljubljana, Slovenia (Recruiting)
- University Medical Centre Maribor — Maribor, Slovenia (Recruiting)
Study contacts
- Study coordinator: Tanja Žnidarič
- Email: tanja.znidaric@gmail.com
- Phone: +386(0)23211917
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.