Trials / Completed
CompletedNCT05440916
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
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- University Medical Centre Maribor · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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%).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-07-14
- Primary completion
- 2025-01-13
- Completion
- 2025-09-01
- First posted
- 2022-07-01
- Last updated
- 2025-12-02
Locations
3 sites across 1 country: Slovenia
Source: ClinicalTrials.gov record NCT05440916. Inclusion in this directory is not an endorsement.