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Checkpoint Inhibitor

Durvalumab + Radiation for Non-Small Cell Lung Cancer

Phase 2

Recruiting

Led By Dawn Owen, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Creatinine ≤ 1.5 x ULN OR glomerular filtration rate (GFR) > 60 mL/min for patients with creatinine > 1.5 x ULN

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years from registration

Awards & highlights

Study Summary

This trial is testing the safety and side effects of giving durvalumab (a monoclonal antibody) and grid therapy (a type of radiation therapy) to patients with non-small cell lung cancer who have progressed during or within 6 months of durvalumab administration.

Who is the study for?

This trial is for adults with non-small cell lung cancer who've seen their cancer progress during or within 6 months after the PACIFIC regimen, which includes durvalumab. They must weigh over 30 kg, have proper kidney and liver function, a stable blood count, and no severe psychiatric conditions or substance abuse issues. Pregnant or nursing individuals can't join, nor those unwilling to use contraception. Participants should not have had certain recent treatments or suffer from active infections like hepatitis B/C or tuberculosis.Check my eligibility

What is being tested?

The trial is testing the combination of durvalumab (an immunotherapy drug) with grid therapy (a type of radiation that targets small areas of tumors). The goal is to see if this combo helps durvalumab work better in killing tumor cells while sparing normal tissue. Durvalumab aims to boost the immune system's attack on cancer by interfering with tumor growth.See study design

What are the potential side effects?

Durvalumab may cause immune-related reactions affecting various organs, fatigue, infusion reactions similar to allergic responses, and increased risk of infection. Grid therapy might lead to localized skin irritation and damage to nearby healthy tissues resulting in symptoms related to the area being treated.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to get out of my bed or chair and move around.

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My kidney function is within the normal range.

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I am 18 years old or older.

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My body weight is over 30 kg.

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I have a tumor outside the brain that is at least 4 cm large, suitable for grid therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years from registration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years from registration

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years from registration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events

Secondary outcome measures

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

Overall response

Time to change another systemic therapy

Other outcome measures

Blood immunity marker (PBMC)

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129

65%

Fatigue

63%

Abdominal pain

55%

Diarrhea

43%

Pain

40%

Weight loss

35%

Hypertension

30%

Constipation

30%

Anorexia

28%

Nausea

28%

Pruritus

25%

Vomiting

20%

Dyspnea

20%

Urinary tract infection

18%

Rash maculo-papular

15%

Back pain

15%

Cough

15%

Abdominal Pain

15%

Weight gain

15%

Increased Urinary Frequency

13%

Arthralgia

10%

Anxiety

10%

Bladder infection

10%

Dizziness

10%

Nasal congestion

10%

Vaginal discharge

Edema limbs

Fever

Anal pain

Dry skin

Colitis

Thromboembolic event

Dry mouth

Flatulence

Headache

Hot flashes

Myalgia

Urinary tract pain

Urinary frequency

Small intestinal obstruction

Anemia

Ascites

Confusion

Pneumonitis

Sinus bradycardia

Renal and urinary disorders - Other, specify

Adrenal insufficiency

Memory impairment

Vaginal hemorrhage

Hypomagnesemia

Upper respiratory infection

Mucositis oral

Rash acneiform

Urinary urgency

Gastroesophageal reflux disease

Lymphedema

Rectal hemorrhage

Colonic perforation

Generalized muscle weakness

Hyperkalemia

Lethargy

Myocarditis

Fall

Skin infection

Hypothyroidism

Muscle weakness left-sided

Alanine aminotransferase increased

Hyperglycemia

Pleural effusion

Creatinine increased

Rectal pain

Aspartate aminotransferase increased

Dysarthria

Myositis

CPK increased

Pain in extremity

Peripheral sensory neuropathy

Alkaline phosphatase increased

Blood bilirubin increased

Left ventricular systolic dysfunction

Weight Loss

100%

80%

60%

40%

20%

Study treatment Arm

Durvalubmab

Durvalubmab + Tremelimumab

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (durvalumab, grid therapy)Experimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

Biospecimen Collection

2004

Completed Phase 2

~1700

Durvalumab

2017

Completed Phase 2

~3870

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,666 Previous Clinical Trials

40,925,994 Total Patients Enrolled

Mayo ClinicLead Sponsor

3,213 Previous Clinical Trials

3,767,000 Total Patients Enrolled

Dawn Owen, M.D.Principal InvestigatorMayo Clinic in Rochester

Media Library

Durvalumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05443971 — Phase 2

Non-Small Cell Lung Cancer Research Study Groups: Treatment (durvalumab, grid therapy)

Non-Small Cell Lung Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT05443971 — Phase 2

Durvalumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05443971 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies left for participants in this scientific experiment?

"Contrary to expectation, the trial listed on clinicaltrials.gov is not presently recruiting for participants. It was originally published in December 2022 and has since been updated once in November of that same year. Nevertheless, there are an abundance of other trials actively seeking out patients at this time - a total of 2045 studies to be precise!"

Answered by AI

Has Durvalumab obtained authorization from the Food and Drug Administration?

"Durvalumab is still being tested in Phase 2 trials, so there is some existing data regarding safety but none yet that confirms efficacy. Thus it was rated a score of 2 by our team at Power."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Dawn M. Owen, M.D., Ph.D. 2023. "Durvalumab and Grid Therapy for Non-small Cell Lung Cancer in Progression During or After Treatment With PACIFIC Regimen". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05443971.