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PD-L1 Inhibitor

Durvalumab After Radiation for Stage 3 Lung Cancer (DUART Trial)

Phase 2
Waitlist Available
Led By Dr Andrea Riccardo Filippi
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 8 weeks ±1 week after ip treatment initiation and continue q8w ±1 week through 48 weeks and q12w ±1 week until disease progression (up to maximum of 12 months)
Awards & highlights

DUART Trial Summary

This trial is testing a new cancer drug to see if it is effective in treating patients with Stage III lung cancer who are not eligible for chemotherapy. The trial will enroll patients into two groups depending on the dose of radiation therapy they have received.

Eligible Conditions
  • Non-Small Cell Lung Cancer

DUART Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 8 weeks ±1 week after investigational product (ip) treatment initiation and continue every 8 weeks (q8w) ±1 week through 48 weeks and every 12 weeks (q12w) ±1 week until disease progression (up to maximum of 12 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 8 weeks ±1 week after investigational product (ip) treatment initiation and continue every 8 weeks (q8w) ±1 week through 48 weeks and every 12 weeks (q12w) ±1 week until disease progression (up to maximum of 12 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with Grade 3 and Grade 4 possibly-related adverse events (PRAEs)
Secondary outcome measures
Duration of response (DoR)
Median Progression-free survival (PFS)
Median overall survival (OS)
+13 more

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
8%
Edema limbs
8%
Fever
8%
Anal pain
8%
Dry skin
8%
Colitis
8%
Thromboembolic event
8%
Dry mouth
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Urinary tract pain
8%
Urinary frequency
8%
Small intestinal obstruction
5%
Anemia
5%
Ascites
5%
Confusion
5%
Pneumonitis
5%
Sinus bradycardia
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Memory impairment
5%
Vaginal hemorrhage
5%
Hypomagnesemia
5%
Upper respiratory infection
5%
Mucositis oral
5%
Rash acneiform
5%
Urinary urgency
5%
Gastroesophageal reflux disease
5%
Lymphedema
3%
Rectal hemorrhage
3%
Colonic perforation
3%
Generalized muscle weakness
3%
Hyperkalemia
3%
Lethargy
3%
Myocarditis
3%
Fall
3%
Skin infection
3%
Hypothyroidism
3%
Muscle weakness left-sided
3%
Alanine aminotransferase increased
3%
Hyperglycemia
3%
Pleural effusion
3%
Creatinine increased
3%
Rectal pain
3%
Aspartate aminotransferase increased
3%
Dysarthria
3%
Myositis
3%
CPK increased
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Left ventricular systolic dysfunction
3%
Weight Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab

DUART Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort BExperimental Treatment1 Intervention
Patients received palliative radiotherapy [40 to < 54 Gy or hypofractionated BED] prior to study entry.
Group II: Cohort AExperimental Treatment1 Intervention
Patients received standard radiotherapy [60 gray (Gy) ± 10% or hypofractionated BED] prior to study entry.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,257 Previous Clinical Trials
288,593,684 Total Patients Enrolled
Dr Andrea Riccardo FilippiPrincipal InvestigatorFondazione IRCCS Policlinico San Matteo

Media Library

Durvalumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04249362 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Cohort A, Cohort B
Non-Small Cell Lung Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT04249362 — Phase 2
Durvalumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04249362 — Phase 2

Frequently Asked Questions

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

For what purposes is Durvalumab commonly prescribed?

"Durvalumab is commonly used to treat advanced cases of stage III non-small cell lung cancer. This medication has also proven useful in treating metastatic ureter urothelial carcinoma and other less common conditions."

Answered by AI

What are the eligibility criteria for participation in this clinical trial?

"This clinical trial is admitting 102 individuals with carcinoma, non-small cell lung cancer. The acceptable age range for participants is 18 to 130 years of age. Notably, prospective patients must meet the following qualifications: World Health Organization/ECOG performance status ≤2., Previous radiation therapy dose between 40 and 66 Gy (standard or hypofractionated BED)., No progression from prior treatment according to Investigator assessed RECIST 1.1 criteria regarding measurability of lesions ., Age ≥18 at study entry., Ineligible for chemotherapy as per investigator assessment., Not having been previously exposed to immune-mediated therapies such as anti-CTLA"

Answered by AI

How many individuals have volunteered for this clinical investigation?

"Currently, this clinical study is not searching for new enrollees. It was originally posted on November 26th 2020 and underwent its last edits on November 23rd 2022. For those seeking other opportunities, 1949 trials are actively recruiting patients with carcinoma non-small cell lung cancer and 333 studies need volunteers to partake in Durvalumab research."

Answered by AI

To what extent are hospitals participating in this research endeavor?

"At the time of writing, 4 centres are recruiting participants for this trial. These sites can be found in Tampa, Tucson and Tacoma as well as several other locations. It is recommended that you select a clinic closest to your residence so that travel demands remain minimal if you decide to join."

Answered by AI

Does this research endeavor have an age requirement of 18 years or older?

"According to the regulatory requirements of this clinical trial, eligible participants must be aged 18 and no older than 130 years."

Answered by AI

To what degree is Durvalumab a danger to human health?

"Durvalumab's safety was rated a 2 since it is in the second phase of clinical trials and has evidence for its safe use, yet there are no studies that verify its efficacy."

Answered by AI

Are there any past experiments involving Durvalumab to reference?

"Durvalumab was first trialed in 2010 at City of Hope and since then, 106 scientific studies have concluded. At the moment, 333 experiments are ongoing with a large number based out of Tampa, Florida."

Answered by AI

Is the trial currently offering enrollment opportunities?

"As indicated on clinicaltrials.gov, this particular research study is no longer accepting patients for enrollment. The trial was first listed in November 2020 and updated last month; yet there are still 2282 other medical trials that need volunteers at the present moment."

Answered by AI
~24 spots leftby Apr 2025