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Lung Non-Small Cell CarcinomaPhase 1NCT05443971

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

A Phase 1 study testing Durvalumab, Radiation Therapy and Biospecimen Collection in people with Lung Non-Small Cell Carcinoma and Stage III Lung Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Durvalumab, Radiation Therapy and Biospecimen Collection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
8 Jan 2024to 17 Dec 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To describe the safety of grid + durvalumab using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.

SECONDARY OBJECTIVES:

  1. Evaluation of overall response rate using Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) in a non-irradiated metastatic lesion.

II. Evaluation of development of any additional sites of metastatic disease in the setting of oligorecurrence or local recurrence alone.

III. Evaluation of response in the radiated lesion using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.

IV. Evaluation of time to change from durvalumab to another systemic therapy.

CORRELATIVE OBJECTIVE:

  1. Monitoring of peripheral blood immunity markers before and after grid therapy.

OUTLINE:

Patients receive durvalumab intravenously (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.

After completion of study treatment, patients are followed up at 30 days and then every 8-12 weeks for up to 5 years from date of registration.

Being tested
Durvalumab, Radiation Therapy, Biospecimen Collection
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DurvalumabBiological

    Also called Imfinzi, Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain

    Given IV

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated

    Undergo grid therapy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

Study groups in NCT05443971
Study groupRoleWhat they receive
Treatment (durvalumab, grid therapy)ExperimentalPatients 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.
Receives: Biological: Durvalumab; Radiation: Radiation Therapy; Procedure: Biospecimen Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within 3 months after grid therapy

Secondary outcomes (3)

  1. Overall response

    Overall response by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 will be estimated using objective response rate (ORR) where ORR is defined as the number of evaluable patients achieving a response (partial response [PR] or better) during treatment with study therapy divided by the total number of evaluable patients. Point estimates will be generated for ORR along with 90% confidence interval using Fisher's exact method. Immune-related (i)RECIST criteria will be used for evaluation of non-irradiated metastatic lesion whereas RECIST 1.1 criterial will be used for evaluation of radiated lesions.

    Measured: Up to 2 years

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

    Will be summarized and reported descriptively.

    Measured: Up to 2 years

  3. Time to change from Durvalumab another systemic therapy

    Will be estimated as time from study entry to time when patient starts non-protocol therapy or another systemic therapy. This time to event endpoint will be estimated using Kaplan-Meier method. Any patient who hasn't started non-protocol therapy or has died/progressed before starting non-protocol therapy will be censored at the time of their last follow-up.

    Measured: Up to 5 years from registration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2022
  2. Study start8 Jan 2024
  3. Primary completion28 Jun 2025
  4. Study completion17 Dec 2025

Why it stopped: slow accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05443971
Sponsor's protocol ID
GMROR2121
Other IDs
NCI-2022-04697, ESR-21-21131, 21-005691
Status last verified
Feb 2026
First submitted
28 Jun 2022
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Durvalumab, Radiation Therapy and Biospecimen Collection in people with Lung Non-Small Cell Carcinoma and Stage III Lung Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: slow accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (time frame: Within 3 months after grid therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05443971.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.

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