Can grid radiation revive immunotherapy in lung cancer?
NCT ID NCT05443971
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early study tested whether combining the immunotherapy drug durvalumab with a special type of radiation called grid therapy could help people with non-small cell lung cancer whose cancer had stopped responding to durvalumab alone. Only 4 patients were enrolled before the study was stopped early. The main goal was to check safety and side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Durvalumab (Imfinzi) and grid radiation therapy
- What this could lead to
- If it works, this could point toward a way to restore immunotherapy effectiveness in lung cancer patients who have stopped responding.
- What could go wrong
- This was a very small pilot study (only 4 patients) that was terminated early, so results are limited and may not apply to others. The combination also carries risks of immune-related side effects and radiation damage.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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4 people
The number who actually took part.
- Started
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Jan 2024
- Finished
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Dec 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Age \>= 18 years * Primary non-small cell lung cancer treated previously on PACIFIC regimen (concurrent chemoradiation followed by durvalumab for stage III lung cancer) * Progression during durvalumab administration or within 6 months after completion of final durvalumab infusion * Body weight \> 30 kg * Extracranial lesion \>= 4 cm amenable to grid therapy * Patients with brain metastases are permitted to enroll * Patients with polymetastatic disease are permitted to enroll * Patients with local recurrence are permitted to enroll * Patients who do not have rapid polymetastatic progression (at the discretion of the enrolling physician) * Patients who have not had stereotactic body radiation therapy (SBRT) within 1 month of enrollment * Patients may receive conventional palliative radiation to other symptomatic metastatic disease * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Hemoglobin \>= 9.0 g/dL (obtained =\< 15 days prior to registration) * Absolute neutrophil count (ANC) \>= 1500/mm\^3 (obtained =\< 15 days prior to registration) * Platelet count \>= 100,000/mm\^3 (obtained =\< 15 days prior to registration) * Total bilirubin =\< 1.5 x upper limit of normal (ULN) or direct bilirubin =\< ULN if total bilirubin is \> 1.5 x ULN (obtained =\< 15 days prior to registration) * Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\< 2.5 x ULN (=\< 5 x ULN for patients with liver involvement) (obtained =\< 15 days prior to registration) * Creatinine ≤ 1.5 x ULN OR glomerular filtration rate (GFR) \> 60 mL/min for patients with creatinine \> 1.5 x ULN * Negative pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only * Persons able to become pregnant OR able to father a child must be willing to use an adequate method of contraception while on treatment and for 120 days after last treatment * Life expectancy \>= 12 weeks * Provide written informed consent * Willingness to provide mandatory blood specimens for correlative research * Willing to return to Mayo Clinic for follow-up (during the Active Monitoring Phase of the study) Exclusion Criteria: * Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown: * Pregnant persons * Nursing persons * Persons of childbearing potential OR able to father a child who are unwilling to employ adequate contraception * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety of the prescribed regimens * Active autoimmune disease requiring systemic treatment, documented history of severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents * NOTE: Exceptions are allowed for: * Vitiligo * Resolved childhood asthma/atopy * Intermittent use of bronchodilators or inhaled steroids * Daily steroids at dose of =\< 10mg of prednisone (or equivalent) * Local steroid injections * Stable hypothyroidism on replacement therapy * Stable diabetes mellitus on non-insulin therapy * Sjogren's syndrome * Uncontrolled intercurrent illness including, but not limited to: * Ongoing or active infection requiring systemic therapy * Interstitial lung disease * Serious, chronic gastrointestinal conditions associated with diarrhea (e.g., Crohn's disease or others) * Known active hepatitis B (i.e., known positive hepatitis B virus \[HBV\] surface antigen \[HBsAg\] reactive) * Known active hepatitis C (i.e., positive for hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] detected by polymerase chain reaction \[PCR\]) * Known active tuberculosis (TB) * Symptomatic congestive heart failure * Unstable angina pectoris * Unstable cardiac arrhythmia or * Psychiatric illness/social situations that would limit compliance with study requirements (e.g., substance abuse) * History of myocardial infarction =\< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm * Hypersensitivity to durvalumab or any of its excipients * Previous adverse event attributed to durvalumab or other PD-1 or PD-L1 directed therapy that led to drug discontinuation * History of grade \>= 3 immune-related adverse event or any grade of immune-related neurologic or ocular adverse event while receiving immunotherapy * Note: Patients who had endocrine adverse events =\< grade 2 are allowed to enroll if they are stable on appropriate replacement therapy and asymptomatic * Other active malignancy \< 6 months prior to registration * EXCEPTIONS: Non-melanotic skin cancer, papillary thyroid cancer, prostate cancer, or carcinoma-in-situ of the cervix, or others curatively treated and now considered to be at less than 30% risk of relapse * Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of investigational product (IP) * Note: Local surgery of isolated lesions for palliative intent is acceptable * History of allogenic organ transplantation * History of active primary immunodeficiency * Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice) * Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV infection (defined as the presence of anti-HBc and absence of HBsAg) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Adjust wording as necessary and consider evaluating at screening for studies with known hepatotoxicity or other relevant requirements * Receipt of live attenuated vaccine within 30 days prior to the first dose of IP * Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP * Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion: * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection) * Systemic corticosteroids at physiologic doses not to exceed \<\<10 mg/day\>\> of prednisone or its equivalent * Steroids as premedication for hypersensitivity reactions (e.g., computed tomography \[CT\] scan premedication)
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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
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
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