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Chemoradiation + Durvalumab for Lung Cancer (ESR1814205 Trial)

Phase 2

Waitlist Available

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

Must not have

History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin, pemetrexed (for patients with adenocarcinoma), etoposide (for patients with squamous cell carcinoma), or immunotherapy

Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic CHF, unstable angina pectoris, cardiac arrhythmia, or psychiatric/social situations that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have allergies to certain cancer drugs similar to carboplatin, pemetrexed, etoposide, or immunotherapy.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I have not received a live vaccine in the last 30 days.

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I am not currently on any cancer treatments like chemotherapy or hormone therapy.

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I have previously been treated with specific immunotherapies.

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I do not have active infections like TB, hepatitis B, C, or HIV.

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My heart's electrical cycle is longer than normal, as shown by recent ECG tests.

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I have received an organ transplant from another person.

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I have or had an autoimmune or inflammatory disorder.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of cycles of durvalumab (MEDI4736) received for each treated patient

Rate of split course chemoradiation completion

Secondary study objectives

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%

Anorexia

30%

Constipation

28%

Nausea

28%

Pruritus

25%

Vomiting

20%

Dyspnea

20%

Urinary tract infection

18%

Rash maculo-papular

15%

Cough

15%

Abdominal Pain

15%

Back pain

15%

Increased Urinary Frequency

15%

Weight gain

13%

Arthralgia

10%

Dizziness

10%

Anxiety

10%

Bladder infection

10%

Nasal congestion

10%

Vaginal discharge

Colitis

Dry mouth

Dry skin

Fever

Anal pain

Edema limbs

Flatulence

Headache

Hot flashes

Myalgia

Small intestinal obstruction

Thromboembolic event

Urinary frequency

Urinary tract pain

Confusion

Renal and urinary disorders - Other, specify

Adrenal insufficiency

Anemia

Ascites

Gastroesophageal reflux disease

Hypomagnesemia

Lymphedema

Memory impairment

Mucositis oral

Pneumonitis

Rash acneiform

Sinus bradycardia

Upper respiratory infection

Urinary urgency

Vaginal hemorrhage

Alanine aminotransferase increased

Aspartate aminotransferase increased

Alkaline phosphatase increased

Colonic perforation

Dysarthria

Blood bilirubin increased

CPK increased

Creatinine increased

Myositis

Rectal hemorrhage

Hypothyroidism

Left ventricular systolic dysfunction

Lethargy

Muscle weakness left-sided

Myocarditis

Rectal pain

Weight Loss

Fall

Generalized muscle weakness

Hyperglycemia

Hyperkalemia

Pain in extremity

Peripheral sensory neuropathy

Pleural effusion

Skin infection

100%

80%

60%

40%

20%

Study treatment Arm

Durvalubmab

Durvalubmab + Tremelimumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~3750

0 / 16Eligibility criteria met