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

NCT05443971 | Terminated Phase 1 DMC FDA Drug

• 4 other identifiers: GMROR2121NCI-2022-04697ESR-21-2113121-005691
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Non-Small Cell Carcinoma; Stage III Lung Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Evaluated using Common Terminology Criteria for Adverse Events version 5.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be provided. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.

  Within 3 months after grid therapy

Secondary Outcomes (3)

• Overall response

  Up to 2 years

• Number of patients who develop any additional sites of metastatic disease in the setting of oligo-recurrence or local recurrence alone

  Up to 2 years

• Time to change from Durvalumab another systemic therapy

  Up to 5 years from registration

Other Outcomes (1)

• Blood immunity marker (PBMC)

  Up to 5 years after registration

Study Arms (1)

Treatment (durvalumab, grid therapy)

EXPERIMENTAL

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.

Biological: Durvalumab; Radiation: Radiation Therapy; Procedure: Biospecimen Collection

Interventions

Durvalumab BIOLOGICAL

Given IV

Also known as: Imfinzi, Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI-4736, MEDI4736

Treatment (durvalumab, grid therapy)

Radiation Therapy RADIATION

Undergo grid therapy

Also known as: Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

Treatment (durvalumab, grid therapy)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (durvalumab, grid therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

durvalumab; Immunoglobulin G; Disulfides; Radiotherapy; Radiation; Specimen Handling

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Sulfides; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrogen Sulfide; Sulfur Compounds; Organic Chemicals; Therapeutics; Physical Phenomena; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Dawn Owen, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 5, 2022
• Study Start: January 8, 2024
• Primary Completion: June 28, 2025
• Study Completion: December 17, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

US (1)