Your session is about to expire
← Back to Search
PD-L1 Inhibitor
Durvalumab + Radiation Therapy for Lung Cancer
Phase 2
Waitlist Available
Led By Narek Shaverdian, 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
Candidates for definitive RT to 60 Gy in 30 fractions
ECOG/WHO PS 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing whether Durvalumab and radiation therapy can improve outcomes for patients with non-small cell lung cancer, compared to the standard sequential chemotherapy and radiation therapy.
Who is the study for?
This trial is for adults with newly diagnosed or recurrent stage II-III non-small cell lung cancer (NSCLC) who can't have surgery and aren't fit for chemotherapy. They should expect to live at least 12 weeks, be able to consent, and meet certain health criteria like proper organ function. Pregnant women, those on recent immunosuppressants, or with other active cancers can't join.Check my eligibility
What is being tested?
The study tests if combining Durvalumab (an immune therapy drug) with radiation therapy delays NSCLC progression compared to the usual treatment sequence of chemo followed by radiation. Participants will receive both Durvalumab and targeted radiation treatments.See study design
What are the potential side effects?
Durvalumab may cause immune-related side effects such as inflammation in various organs, skin reactions, hormone gland problems, infusion reactions; fatigue is also common. Radiation might lead to skin irritation at the site of treatment and fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a candidate for a specific radiation therapy plan.
Select...
I can take care of myself and perform daily activities.
Select...
My lung cancer type has been confirmed by a standard biopsy.
Select...
My body weight is over 30kg.
Select...
My lung cancer is at stage II-III and can be treated with radiation and durvalumab.
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
2-year PFS rate
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: Non-Small Cell Lung CancerExperimental Treatment2 Interventions
All participants have locally-advanced non-small cell lung cancer, Stage II-III. Treatment will consist of durvalumab administered concurrently with thoracic radiation consisting of 60 Gy in 30 fractions. Patients will be monitored weekly during on-treatment visits. Durvalumab will then be continued up to 1 year as maintenance or until disease progression or unacceptable toxicity. Optional Research MRIs (Does not apply to the Alliance Sites. Research MRIs will only be done at MSKCC)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Durvalumab
2017
Completed Phase 2
~3870
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,559 Total Patients Enrolled
Narek Shaverdian, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
201 Total Patients Enrolled
Andreas Rimner, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
11 Previous Clinical Trials
351 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a lung or esophagus condition that needs treatment.I cannot undergo radiotherapy due to health reasons.I can take care of myself and perform daily activities.I have another cancer that is getting worse or needs treatment.Female participants must either be past menopause or have a negative pregnancy test if they are still having periods.My lung cancer type has been confirmed by a standard biopsy.I am not pregnant or breastfeeding and willing to use effective birth control during and up to 90 days after treatment.I can sign and will follow the study's rules as explained in the consent form.I am willing and able to follow the study's treatment and visit schedule.I cannot have surgery or combined chemo and radiation for my condition due to health reasons.I am a candidate for a specific radiation therapy plan.My body weight is over 30kg.You have received certain types of medications in the recent past that may interfere with the study drug or affect your immune system.I've had chest radiation that prevents me from getting more targeted radiation therapy.I have a serious heart condition.I am 18 years old or older.I have not had major surgery in the last 28 days.You have received an organ from another person through a transplant surgery.I have a serious illness besides my cancer.I have a lung condition not caused by an infection.I have not received any live vaccines within 4 weeks before starting durvalumab.My lung cancer is at stage II-III and can be treated with radiation and durvalumab.I do not have an active infection like TB or hepatitis B.My cancer has a specific change in the EGFR or ALK gene.You are expected to live for at least 12 more weeks.I don't have lasting side effects from cancer treatment, except for hair loss or skin changes.My blood counts and liver/kidney functions are within normal ranges.I have or had an autoimmune or inflammatory disorder.
Research Study Groups:
This trial has the following groups:- Group 1: 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.
What is the current status of Durvalumab in regards to government regulation?
"Phase 2 trials are limited in the amount of safety data that is available, so our team at Power has given Durvalumab a score of 2."
Answered by AI
Are new participants still being accepted into this research project?
"The listing on clinicaltrials.gov indicates that the research team is looking for patients to enroll in this study. The first posting was on 7/19/2019, with the most recent update taking place on 10/5/2022. There are 9 locations where a total of 53 people can join the trial."
Answered by AI
What are the chief indications for Durvalumab?
"Durvalumab is a medication used to treat patients with inoperable stage III non-small cell lung cancer. Additionally, durvalumab can be given to people suffering from metastatic urothelial carcinoma and advance directives."
Answered by AI
How many individuals are currently participating in this clinical trial?
"In order to run this study, 53 patients who fit the pre-specified inclusion criteria are required. Luckily, there are many locations that participants can choose from, such as Memorial Sloan Kettering Bergen in Montvale and Baptist Alliance Miami Cancer Institute in New york."
Answered by AI
Is this research being conducted in several different places within city limits?
"Memorial Sloan Kettering Bergen in Montvale, Baptist Alliance Miami Cancer Institute in Miami, and Memoral Sloan Kettering Monmouth in Middletown are just some of the 9 enrolment sites for this study."
Answered by AI
Does Durvalumab have a long history of being tested in different medical trials?
"City of Hope was the first to study durvalumab back in 2010 and, since then, there have been a further 212 completed trials. As it stands, there are 338 active clinical studies being conducted; a significant number of these taking place in Montvale, Florida."
Answered by AI
Popular Categories
Share this study with friends
Copy Link
Messenger