Restoring Sensitivity to Immunotherapy Post Failure to the Pacific Regimen: A Pilot Study of Combined Durvalumab (MEDI 4736) and Grid Therapy for Non-Small Cell Lung Cancer

Status: Recruiting
Location: See location...
Intervention Type: Radiation, Biological, Procedure
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Minnesota
Mayo Clinic in Rochester
RECRUITING
Rochester
Contact Information
Primary
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Time Frame
Start Date: 2024-01-08
Estimated Completion Date: 2031-08-04
Participants
Target number of participants: 11
Treatments
Experimental: Treatment (durvalumab, grid therapy)
Patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo grid therapy on day 1. Beginning 7-14 days after grid therapy, patients also undergo palliative radiation therapy for 5 fractions. Additionally, patients undergo blood sample collection at baseline and throughout study.
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov

Similar Clinical Trials