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PD-L1 Inhibitor
Durvalumab + Radiation for Lung Cancer
Phase 2
Recruiting
Led By Charles Simone, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
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 2 years
Awards & highlights
Study Summary
This trial will compare the effectiveness of durvalumab + SBRT to SBRT alone in treating early-stage NSCLC.
Who is the study for?
This trial is for adults with early-stage non-small cell lung cancer who can't or choose not to have surgery. They should be in good physical condition, weigh over 30kg, and have a life expectancy of at least 12 weeks. Patients must not have certain mutations, autoimmune diseases, severe illnesses, or previous treatments that could interfere with the study.Check my eligibility
What is being tested?
The study is testing if combining durvalumab (a drug) with stereotactic body radiation therapy (SBRT) works better than SBRT alone for treating early-stage non-small cell lung cancer. Participants will receive both the drug and radiation to see if this improves their treatment outcomes.See study design
What are the potential side effects?
Durvalumab may cause immune-related side effects like inflammation in various organs, skin reactions, hormone gland problems (like thyroid), fatigue, nausea and potential infusion-related reactions. Radiation therapy might lead to skin irritation and fatigue.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival
Side effects data
From 2022 Phase 2 trial • 80 Patients • NCT0301512965%
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: Participants with Early-stage Non-Small Cell Lung CancerExperimental Treatment2 Interventions
Participants will be diagnosed with Stage I-IIIA NSCLC and will be ineligible for surgery and will have any level of PD-L1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,938 Previous Clinical Trials
588,331 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,276 Previous Clinical Trials
288,614,444 Total Patients Enrolled
Charles Simone, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
100 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received treatments before.I have had cancer spread to the lining of my brain and spinal cord.I will not donate blood while on durvalumab treatment.You weigh more than 30 kilograms.I've had chest radiation that prevents targeted radiation for my current tumor.My lung cancer is in an early stage (I to IIIA) without spread to nearby nodes.I have not received any live vaccines in the last 4 weeks and won't while on the trial, except for inactivated vaccines.I am fully active or able to carry out light work.I cannot have radiotherapy due to certain health reasons.My cancer has a specific change in the EGFR or ALK gene.I cannot or do not want to have surgery for my condition as advised by a specialist.I don't have lasting side effects from cancer treatment, except for hair loss or skin changes.Based on a specific test, it is predicted that there is a high chance of the disease getting worse within 2 years.I can sign and will follow the study's rules as explained in the consent form.I have or had an autoimmune or inflammatory disorder.You have to have a standard biopsy confirming non-small cell lung cancer. There is no need for an extra biopsy for this study.I am 18 years old or older.I am a candidate for targeted radiation therapy.You are expected to live for at least 12 more weeks.I haven't had major surgery in the last 28 days, except for minor surgeries to relieve symptoms.You have a history of a weak immune system that has been active.I am not pregnant, breastfeeding, and willing to use effective birth control during and up to 90 days after treatment.I have a connective tissue disorder or lung scarring.My organs and bone marrow are functioning well.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with Early-stage Non-Small Cell Lung Cancer
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there other examples in the medical literature of Durvalumab's effects?
"City of Hope was the first institution to study durvalumab back in 2010 and, since then, 123 completed studies have been conducted. As of now, there are 338 active trials recruiting patients with a majority taking place in Middletown, New jersey."
Answered by AI
In how many different medical clinics is this clinical study being conducted?
"To make things more convenient for participants, the trial is being conducted at 9 sites close to major cities. The locations are Middletown, New york and Commack along with other locations within a commutable distance."
Answered by AI
Are we still taking people in for this research project?
"The clinical trial, which is hosted on clinicaltrials.gov, is currently recruiting patients. The study was posted on 1/27/2021 and updated on 10/12/2022. They are looking for a total of 40 participants that will be spread out across 9 locations."
Answered by AI
What is the most popular reason that doctors prescribe Durvalumab?
"Durvalumab is a common treatment for unresectable stage iii non-small cell lung cancer. Durvalumab has also shown to be effective against metastatic ureter urothelial carcinoma, and advance directives."
Answered by AI
What is the official government stance on Durvalumab?
"While Phase 2 trials don't have the same level of data to support efficacy, there is enough evidence of safety to give Durvalumab a score of 2."
Answered by AI
How many people can enroll in this clinical trial?
"That is correct. The study, which was created on 1/27/2021 and last updated on 10/12/2022, is still looking for enrollees. In total, they need 40 patients from 9 different locations."
Answered by AI
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