← Back to Search

Checkpoint Inhibitor

Durvalumab for Non-Small Cell Lung Cancer

Phase 1
Waitlist Available
Led By Michael Bassetti, MD, PhD
Research Sponsored by University of Wisconsin, Madison
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 up to 4 years
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that combines two types of immunotherapy drugs with radiation therapy. The goal is to see if this is a safe and effective treatment for people with a certain type of lung cancer.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability of SBRT followed by combined durvalumab and tremelimumab, assessed by CTCAE v4.03
Secondary outcome measures
Overall Survival assessed with RECIST 1.1 tumor assessments
Progression Free Survival assessed with RECIST 1.1 tumor assessments
Other outcome measures
Evaluate PD-L1 expression
Evaluate immune response

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: SBRT followed by Durvalumab+TremelimumabExperimental Treatment3 Interventions
Therapeutic Interventions Stereotactic Body Radiotherapy (SBRT) to all sites of disease between 30 and 50 Gy in five fractions administered over two weeks. Investigational Product(s), Dose, and Mode of Administration: to begin 7 days (+/- 3 days) after radiation Durvalumab 1500 mg via infusion Q4W (equivalent to 20 mg/kg Q4W) until disease progression in patients > 30 kg Tremelimumab 300 mg via infusion (equivalent to 4 mg/kg) in one dose in patients >30 kg Weight-based dosing should be utilized for patients ≤30 kg; durvalumab 20 mg/kg Q4W and tremelimumab 4 mg/kg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Tremelimumab
2017
Completed Phase 2
~3380
Stereotactic Body Radiotherapy
2017
Completed Phase 2
~220

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,189 Previous Clinical Trials
3,169,529 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,271 Previous Clinical Trials
288,612,686 Total Patients Enrolled
Michael Bassetti, MD, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
1 Previous Clinical Trials
48 Total Patients Enrolled

Frequently Asked Questions

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

What potential risks exist with Durvalumab treatment?

"As this is an early-stage clinical trial, the safety of Durvalumab was rated a 1 due to limited data available on its efficacy and health risks."

Answered by AI

To what medical issues is Durvalumab commonly applied?

"Durvalumab is the medication of choice for treating unresectable stage III non-small cell lung cancer and metastatic ureter urothelial carcinoma. It has also been known to provide relief in cases of advanced directives."

Answered by AI

Has this clinical trial broken new ground in its field?

"Since 2007, AstraZeneca has been researching the immunotherapy drug Durvalumab. This endeavour began with a Phase 1 study involving 37 patients and culminated in its approval for use in clinical trials. Nowadays, there are 340 ongoing studies utilizing this medication which span 58 countries and 1327 cities."

Answered by AI

Is the recruitment period for this trial still open?

"This investigation has paused recruitment, with its first posting on February 20th 2018 and most recent edit occurring September 21st 2022. However, there are 1,950 clinical trials enrolling patients with non-small-cell lung carcinoma and 340 studies actively admitting participants for Durvalumab treatment."

Answered by AI

To what limit have participants been recruited for this research?

"At this time, the trial is not enrolling new individuals. The study was published on February 20th 2018 and most recently updated on September 21st 2022. For those seeking alternative trials, there are 1,950 cancer-related studies recruiting patients with non-small cell lung carcinoma and 340 for Durvalumab actively searching for participants."

Answered by AI

Has Durvalumab been tested in any other medical experiments?

"Currently, there are 340 clinical trials using Durvalumab as the main research intervention with 52 of them in their third phase. Cordoba Texas is one such place where these studies take place; however, 13098 locations across the world are conducting similar investigations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase Ib Study of Stereotactic Body Radiotherapy (SBRT) in Oligometastatic Non-small Lung Cancer (NSCLC) With Dual Immune Checkpoint Inhibition
2018. "Phase Ib Study of Stereotactic Body Radiotherapy (SBRT) in Oligometastatic Non-small Lung Cancer (NSCLC) With Dual Immune Checkpoint Inhibition". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03275597.
~2 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top