Carcinoma, Non-Small-Cell LungPhase 2PRIMMNCT05440916
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
A Phase 2 study testing Palliative Radiotherapy: 5 x 4Gy and chemotherapy + immune checkpoint inhibitors in people with Carcinoma, Non-Small-Cell Lung and Metastatic Lung Non-Small Cell Carcinoma, run by University Medical Centre Maribor at 3 sites in Slovenia.
Trial 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%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Metastatic Lung Non-Small Cell Carcinoma, Non Small Cell Lung Cancer
- What is being tested?
- Palliative Radiotherapy: 5 x 4Gy and chemotherapy + immune checkpoint inhibitors
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesSlovenia
- Study dates
- 14 Jul 2022to 1 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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)
Trial locations and contacts
3 sites in 1 country.
Slovenia3 sites
University Clinic Golnik
Golnik, 4204
Institute of Oncology Ljubljana
Ljubljana, 1000
University Medical Centre Maribor
Maribor, 2000
About this study
Official title: 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)
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.
Read the 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
- Carcinoma, Non-Small-Cell Lung, Metastatic Lung Non-Small Cell Carcinoma, Non Small Cell Lung Cancer
- Being tested
- Palliative Radiotherapy: 5 x 4Gy, chemotherapy + immune checkpoint inhibitors
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative Radiotherapy: 5 x 4GyRadiation
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.
chemotherapy + immune checkpoint inhibitorsDrug
Systemic therapy according to national/European recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Patients with metastatic Non-Small Cell Lung Carcinoma eligible for first line systemic treatment with chemotherapy and immune checkpoint inhibitors (PDL1 less than 50%)
Radiotherapy: palliative irradiation of 2 to 5 sites (parenchymal/bone/soft tissue metastasis and/or primary lung tumour) with fractionation: 5 fractions of 4Gy (total dose 20Gy) in one week before systemic therapy. Receives: Radiation: Palliative Radiotherapy: 5 x 4Gy; Drug: chemotherapy + immune checkpoint inhibitors |
| Historical cohort | Other | Patients with metastatic Non-Small Cell Lung Carcinoma treated with first line of systemic therapy with chemotherapy and immune checkpoint inhibitors (PDL1 less than 50%).
Radiotherapy: no radiation therapy during the first line of systemic treatment before progression of disease. Receives: Drug: chemotherapy + immune checkpoint inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Disease status will be evaluated based on imaging results until progression or death; assessed every three months.
Measured: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months after the completion of study.
Secondary outcomes (4)
Overall Survival (OS)
Amount of time from treatment until death, reported via follow up visit or phone call.
Measured: From the date of randomization until the date of death, or the last follow up date on which the participant was reported alive, assessed up to 18 months.
Objective Response Rate (ORR)
Using assessment according to RECIST (after 3 months and time to ORR). Percentage of patients with a complete response or partial response.
Measured: Assessment after 3 months after the date of randomization and every 3 months up until progression. Assessed up to 18 months after the completion of study.
Patterns of progression
Percentage of patients with recorded first site of progression of disease at irradiated sites and non-irradiated sites or both.
Measured: Assessed up to 18 months after the completion of study.
A review of predictive maker PDL1 - indicating a better response to combination therapy
- Percentage of PDL 1 expression on tumour cells, where PFS was significantly better in combination therapy.
Measured: From the start of treatment until the date of documented progression or death, whichever comes first, assessed up to 18 months after the completion of study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start14 Jul 2022
- Primary completion13 Jan 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Maribor
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Oncology Ljubljana, The University Clinic of Pulmonary and Allergic Diseases Golnik
- Responsible party
- Principal investigator, Tanja Znidaric Rakar, University Medical Centre Maribor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440916
- Sponsor's protocol ID
- 0120-127/2022/3
- Acronym
- PRIMM
- Status last verified
- Nov 2025
- First submitted
- 30 May 2022
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05440916
- Acronym / sponsor ID
- PRIMM / 0120-127/2022/3
- Conditions
- Carcinoma, Non-Small-Cell Lung, Metastatic Lung Non-Small Cell Carcinoma, Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Medical Centre MariborUniversity, hospital or other
- Collaborators
- Institute of Oncology Ljubljana, The University Clinic of Pulmonary and Allergic Diseases Golnik
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 13 Jan 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 1 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Radiation: Palliative Radiotherapy: 5 x 4Gy, Drug: chemotherapy + immune checkpoint inhibitorsPatients with metastatic Non-Small Cell Lung Carcinoma eligible for first line systemic treatment with chemotherapy and immune checkpoint inhibitors (PDL1 less than 50%) Radiotherapy: palliative irradiation of 2 to 5 sites (parenchymal/bone/soft tissue metastasis and/or primary lung tumour) with fractionation: 5 fractions of 4Gy (total dose 20Gy) in one week before systemic therapy. |
| Historical cohort | Other | Drug: chemotherapy + immune checkpoint inhibitorsPatients with metastatic Non-Small Cell Lung Carcinoma treated with first line of systemic therapy with chemotherapy and immune checkpoint inhibitors (PDL1 less than 50%). Radiotherapy: no radiation therapy during the first line of systemic treatment before progression of disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palliative Radiotherapy: 5 x 4GyPalliative 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. | Radiation | Study group |
| chemotherapy + immune checkpoint inhibitorsSystemic therapy according to national/European recommendations. | Drug | Historical cohort, Study group |
Primary outcome
Progression Free Survival (PFS)
Time frame: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months after the completion of study.
Disease status will be evaluated based on imaging results until progression or death; assessed every three months.
4 secondary outcomes
Overall Survival (OS)
Time frame: From the date of randomization until the date of death, or the last follow up date on which the participant was reported alive, assessed up to 18 months.
Objective Response Rate (ORR)
Time frame: Assessment after 3 months after the date of randomization and every 3 months up until progression. Assessed up to 18 months after the completion of study.
Patterns of progression
Time frame: Assessed up to 18 months after the completion of study.
A review of predictive maker PDL1 - indicating a better response to combination therapy
Time frame: From the start of treatment until the date of documented progression or death, whichever comes first, assessed up to 18 months after the completion of study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Carcinoma, Non-Small-Cell Lung
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Palliative Radiotherapy: 5 x 4Gy and chemotherapy + immune checkpoint inhibitors in people with Carcinoma, Non-Small-Cell Lung and Metastatic Lung Non-Small Cell Carcinoma, run by University Medical Centre Maribor at 3 sites in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months after the completion of study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.