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Checkpoint Inhibitor

Durvalumab + Tremelimumab with Chemotherapy for Non-Small Cell Lung Cancer

Q: What medical conditions is Durvalumab typically prescribed to address?

<p>Patients with unresectable stage III non-<a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">small cell lung cancer</a> that have not been treated previously, as well as those battling metastatic urothelial carcinoma of the ureter may find relief through Durvalumab.</p>

Phase 2

Recruiting

Research Sponsored by Georgetown University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cohort 2: Patients with chronic HBV infection (defined by persistence of HBsAg for more than six months) will be eligible

Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

Study Summary

This trial is testing whether the drug durvalumab, in combination with standard chemotherapy, is safe and effective for treating stage IV non-small-cell lung cancer (NSCLC) in patients with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.

Who is the study for?

This trial is for adults over 18 with stage IV Non-Small-Cell Lung Cancer and HIV, HBV, or HCV infections. They must have no prior systemic therapy for stage IV disease, be on effective anti-viral therapy if needed, and have an ECOG performance status of 0-2. Exclusions include brain radiation within the last 2 weeks, unresolved toxicity from previous cancer treatments (except hair loss), autoimmune disorders, CNS metastases or leptomeningeal disease, recent live vaccines, organ transplants, pregnancy/breastfeeding without birth control use.Check my eligibility

What is being tested?

The trial tests Durvalumab and Tremelimumab combined with platinum-based chemotherapy in virus-infected patients. It aims to determine safety and effectiveness in treating lung cancer among those also dealing with HIV/HBV/HCV. Participants will undergo four cycles of treatment every three weeks followed by maintenance therapy.See study design

What are the potential side effects?

Potential side effects may include immune-related reactions affecting organs due to Durvalumab/Tremelimumab's action on the immune system; infusion reactions; fatigue; digestive issues like nausea or diarrhea; blood cell count changes increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had chronic hepatitis B for more than six months.

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I am willing and able to follow the study's treatment plan and attend all visits.

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I am able to get out of my bed or chair and move around.

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My organs and bone marrow are functioning well.

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I am HBV positive, have active disease, and am on anti-HBV therapy.

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I am older than 18 years.

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I do not have any other cancers that cannot be cured.

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My body weight is over 30kg.

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I have detectable HBV DNA but test negative for HBsAg.

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I am post-menopausal or not pregnant if pre-menopausal.

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I have had hepatitis B but do not currently have an active infection.

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I haven't had any AIDS-related infections in the past year.

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I have stage IV NSCLC and haven't had systemic therapy for it.

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I am currently being treated for hepatitis C.

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I have finished treatment for hepatitis C and no longer have detectable virus.

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I have HIV and have been on effective HIV medication for at least 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events

Radiological Response

Secondary outcome measures

Change in Cytokine Secretion Assays

Changes in Viral Load

Correlation of Multiplex IHC to response

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: durvalumab (MEDI4736) and tremelimumabExperimental Treatment2 Interventions

Durvalumab in combination with tremelimumab and platinum-based doublet chemotherapy. Only subjects who achieve stable disease or better radiological response after 4 cycles of induction treatment will be eligible to continue study treatment with durvalumab in maintenance.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3870

Tremelimumab

2017

Completed Phase 2

~3380

0 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaIndustry Sponsor

4,259 Previous Clinical Trials

288,593,884 Total Patients Enrolled

Georgetown UniversityLead Sponsor

343 Previous Clinical Trials

136,484 Total Patients Enrolled

Chul Kim, MDStudy ChairGeorgetown University

4 Previous Clinical Trials

52 Total Patients Enrolled

Frequently Asked Questions

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

Can you outline any other studies that have delved into the therapeutic potential of Durvalumab?

"Durvalumab was first investigated in 2010 at City of Hope, and since then an impressive 106 clinical trials have been concluded. As of today there are 333 active studies on this drug, with numerous Washington D.C.-based medical centres taking part."

Answered by AI

Could the risk of using Durvalumab potentially harm patients?

"Data on Durvalumab's safety is promising, resulting in the drug being given a rating of 2. This tentative score is justified by the fact that we are still in Phase 2 trials and have yet to collect data supporting efficacy."

Answered by AI

What medical conditions is Durvalumab typically prescribed to address?

"Patients with unresectable stage III non-small cell lung cancer that have not been treated previously, as well as those battling metastatic urothelial carcinoma of the ureter may find relief through Durvalumab."

Answered by AI

How many individuals is the maximum capacity of this clinical trial?

"Affirmative, the clinicaltrials.gov website shows that this trial is presently recruiting participants. Initially posted on December 9th 2020, this research project requires 18 enrollees from three medical sites and was recently updated on June 10th 2022."

Answered by AI

Are there any vacancies still available to join this medical study?

"Affirmative. The data hosted on clinicaltrials.gov supports the fact that this medical study is currently seeking volunteers, with 18 positions needing to be filled at 3 distinct locations since its opening post on December 9th 2020 and most recent update in June 10th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Durvalumab and Tremelimumab in Combination With Chemotherapy in Virus-infected Patients With Non-small Cell Lung Cancer

2020. "Durvalumab and Tremelimumab in Combination With Chemotherapy in Virus-infected Patients With Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04499053.

All > Lung Cancer Baltimore