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Chemoradiation + Durvalumab for Lung Cancer (ESR1814205 Trial)
Phase 2
Recruiting
Led By Gaurav Marwaha, MD
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have normal organ and marrow function: Leukocytes >3000/mcL; ANC >1500/mcL; PLT>100000/mcL; Hemoglobin ≥9.0 g/dL
Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
ESR1814205 Trial Summary
This trial is for elderly or poor-risk patients with inoperable NSCLC who have not been previously treated. It is a phase II study, which means that researchers are still determining if the treatment is effective. The treatment consists of chemoradiation (a combination of chemotherapy and radiation) followed by the immunotherapy drug Durvalumab.
Who is the study for?
This trial is for elderly (70+ years) or adults over 18 with poor risk stage IIIA-C NSCLC who are medically inoperable. They must have no brain metastases, weigh more than 30kg, and be able to follow the study protocol. Their organs must function well, they should not be pregnant, and agree to use birth control.Check my eligibility
What is being tested?
The trial tests Durvalumab following chemoradiation in patients with stage III NSCLC who are either elderly or at a poor risk due to their health status. It's an open-label phase II study where all participants receive the same treatment without a comparison group.See study design
What are the potential side effects?
Durvalumab may cause immune-related side effects like inflammation of organs, infusion reactions, fatigue, possible blood disorders and increased infection risks. Side effects can vary from person to person.
ESR1814205 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood tests show normal organ function and healthy blood cell counts.
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My kidney function, measured by creatinine clearance, is above 40 mL/min.
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I am post-menopausal or not pregnant if pre-menopausal.
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I am willing and able to follow the study's treatment plan and attend all visits.
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My lung cancer is at stage IIIA-C and will be treated to cure it.
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A medical team has decided surgery isn't an option for my cancer.
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My body weight is over 30kg.
ESR1814205 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of cycles of durvalumab (MEDI4736) received for each treated patient
Rate of split course chemoradiation completion
Secondary outcome measures
One-Year Loco-regional Progression-free Survival (PFS) according to RECIST 1.1
One-year Overall Survival (OS)
One-year Progression-Free Survival (PFS) according to RECIST 1.1
+1 moreSide 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
ESR1814205 Trial Design
1Treatment groups
Experimental Treatment
Group I: Concurrent, Split Course Chemoradiation Followed by DurvalumabExperimental Treatment1 Intervention
Concurrent, Split Course Chemoradiation Followed by Durvalumab (MEDI4736) in Poor Risk and/or Elderly Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer
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?
Rush University Medical CenterLead Sponsor
424 Previous Clinical Trials
156,705 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,289 Previous Clinical Trials
288,620,168 Total Patients Enrolled
Gaurav Marwaha, MDPrincipal Investigator - Rush University Cancer Center
Rush Oak Park Hospital, Rush University Medical Center
University Of Cincinnati College Of Medicine (Medical School)
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