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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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year 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 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 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

Edema limbs

Fever

Anal pain

Dry skin

Colitis

Thromboembolic event

Dry mouth

Flatulence

Headache

Hot flashes

Myalgia

Urinary tract pain

Urinary frequency

Small intestinal obstruction

Anemia

Ascites

Confusion

Pneumonitis

Sinus bradycardia

Renal and urinary disorders - Other, specify

Adrenal insufficiency

Memory impairment

Vaginal hemorrhage

Hypomagnesemia

Upper respiratory infection

Mucositis oral

Rash acneiform

Urinary urgency

Gastroesophageal reflux disease

Lymphedema

Rectal hemorrhage

Colonic perforation

Generalized muscle weakness

Hyperkalemia

Lethargy

Myocarditis

Fall

Skin infection

Hypothyroidism

Muscle weakness left-sided

Alanine aminotransferase increased

Hyperglycemia

Pleural effusion

Creatinine increased

Rectal pain

Aspartate aminotransferase increased

Dysarthria

Myositis

CPK increased

Pain in extremity

Peripheral sensory neuropathy

Alkaline phosphatase increased

Blood bilirubin increased

Left ventricular systolic dysfunction

Weight Loss

100%

80%

60%

40%

20%

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

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor

422 Previous Clinical Trials

163,471 Total Patients Enrolled

AstraZenecaIndustry Sponsor

4,271 Previous Clinical Trials

288,612,829 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)

Frequently Asked Questions

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

What are the investigators of this trial hoping to discover?

"The research team plans to monitor this study for a whole year in order to gauge the efficacy of split course chemoradiation in relation to completion rates. Additionally, they will secondary outcomes including One-year Progression-Free Survival (PFS) and Rate of grade 3 and 4 toxicities."

Answered by AI

For what purpose is Durvalumab most commonly prescribed?

"Durvalumab is frequently used to treat unresectable stage iii non-small cell lung cancer. However, it has also been known to be effective in treating other conditions such as previously untreated, metastatic ureter urothelial carcinoma and advance directives."

Answered by AI

Has the FDA cleared Durvalumab for public use?

"Durvalumab's safety was given a score of 2 because, although there is evidence of its safety from Phase 2 trials, there is no data currently indicating that it is an effective medication."

Answered by AI

How many people are being included in this research project?

"That is correct. The latest information from clinicaltrials.gov shows that this trial, which was originally posted on February 25th 2021, is still recruiting patients. They are looking for 30 individuals at 1 location."

Answered by AI

Are new participants still being sought for this clinical trial?

"This study is looking for participants and was originally posted on February 25th, 2021. The most recent update to the listing was on September 21st, 2022."

Answered by AI

What else is known about Durvalumab from other research?

"At the moment, there are 338 clinical trials underway that involve Durvalumab. Out of those studies, 51 are in Phase 3 testing. The vast majority of these tests are taking place Cordoba, Texas; however, 12905 other locations worldwide are also running similar investigations."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Durvalumab After Chemoradiotherapy in Stage III Non–small-cell Lung Cancer

Antonia, Scott J., Augusto Villegas, Davey Daniel, David Vicente, Shuji Murakami, Rina Hui, Takashi Yokoi, et al.. 2017. “Durvalumab After Chemoradiotherapy in Stage III Non–small-cell Lung Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1709937.

Annual Review of ImmunologyJournal

PD-1 and Its Ligands in Tolerance and Immunity

Keir, Mary E., Manish J. Butte, Gordon J. Freeman, and Arlene H. Sharpe. 2008. “PD-1 and Its Ligands in Tolerance and Immunity”. Annual Review of Immunology. Annual Reviews. doi:10.1146/annurev.immunol.26.021607.090331.

Contemporary Clinical TrialsJournal

Analysis of Duration of Response in Oncology Trials

Ellis, Stuart, Kevin J. Carroll, and Kristine Pemberton. 2008. “Analysis of Duration of Response in Oncology Trials”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2007.10.008.

International Journal of OncologyJournal