Durvalumab and Grid Therapy for Non-small Cell Lung Cancer in Progression During or After Treatment With PACIFIC Regimen

Stopped early · Phase 1

Conditions studied: Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8

In brief

This phase II trial tests the safety and side effects of durvalumab and grid therapy in treating patients with non-small cell lung cancer who have progressed during or within 6 months of durvalumab administration for non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy sources to kill tumor cells and shrink tumors. Spatially fractionated radiation therapy or "grid therapy" is a technique which delivers high doses of radiation to small areas of the tumor which can lead to more concentrated tumor cell killing and causes less damage to normal tissue. Giving grid therapy with durvalumab may help durvalumab work better to kill tumor cells in patients with non-small cell lung cancer.

Key facts

Study ID

NCT05443971

Run by

Mayo Clinic

People needed

4

Starts

2024-01-08

Expected to finish

2025-12-17

Last updated by the study team

2026-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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