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Radiation before Chemo-Immunotherapy shows promise in advanced lung cancer

NCT ID NCT05440916

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether giving palliative radiation to several tumor sites before starting standard immunotherapy and chemotherapy can help people with metastatic non-small cell lung cancer. Fifty adults with cancer that had spread and low PD-L1 levels received radiation to 2 to 5 spots, then started standard treatment. The goal was to see if this approach improves how long the cancer stays under control compared to standard treatment alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

50 people

The number who actually took part.

Started

Jul 2022

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Institute of Oncology Ljubljana

    Ljubljana, 1000, Slovenia

  • University Clinic Golnik

    Golnik, 4204, Slovenia

  • University Medical Centre Maribor

    Maribor, 2000, Slovenia

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