Durvalumab for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Non-Small Cell Lung CancerDurvalumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Durvalumab
1
Durvalumab
1
Durvalumab

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: 36 months

36 months
Change in Cytokine Secretion Assays
Correlation of Multiplex IHC to response
Week 3
Adverse Events
Changes in Viral Load
Radiological Response

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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Side Effects for

DUR + R-CHOP
60%Fatigue
49%Peripheral sensory neuropathy
47%Neutropenia
40%Nausea
28%Diarrhoea
26%Decreased appetite
26%Insomnia
23%Dyspnoea
23%Alopecia
23%Headache
21%Dizziness
21%Pyrexia
21%Vomiting
21%Constipation
21%Dysgeusia
19%Hypokalaemia
19%Cough
19%Stomatitis
16%Anaemia
16%Weight decreased
16%Rash
16%Dry mouth
16%Leukopenia
16%Myalgia
14%Back pain
14%Oropharyngeal pain
14%Febrile neutropenia
12%Oedema peripheral
12%Infusion related reaction
12%Oral candidiasis
12%Abdominal pain upper
9%Mucosal inflammation
9%Thrombocytopenia
9%Fall
9%Urinary tract infection
9%Chills
9%Pruritus
7%Pain in extremity
7%Arthralgia
7%Lung infection
7%Abdominal pain
7%Dry skin
7%Hot flush
7%Muscle spasms
7%Hypotension
7%Vision blurred
7%Nasopharyngitis
7%Hypomagnesaemia
5%Atrial fibrillation
5%Pneumonia
5%Dysuria
5%General physical health deterioration
5%Oral herpes
5%Influenza
5%Infection
2%Erythema
2%Lymphoma
2%Myocardial ischaemia
2%Gastrooesophageal reflux disease
2%Device related infection
2%Pulmonary embolism
2%Spinal pain
2%Perirectal abscess
2%Clear cell renal cell carcinoma
2%Venous thrombosis
2%Cardiac arrest
2%Pancytopenia
2%Tumour pain
2%Seborrhoeic dermatitis
2%Deep vein thrombosis
2%Viral diarrhoea
2%Cerebrovascular accident
2%Restless legs syndrome
2%Autoimmune hepatitis
2%Acute kidney injury
2%Hyponatraemia
2%Histiocytosis haematophagic
This histogram enumerates side effects from a completed 2022 Phase 2 trial (NCT03003520) in the DUR + R-CHOP ARM group. Side effects include: Fatigue with 60%, Peripheral sensory neuropathy with 49%, Neutropenia with 47%, Nausea with 40%, Diarrhoea with 28%.

Trial Design

1 Treatment Group

durvalumab (MEDI4736)
1 of 1

Experimental Treatment

18 Total Participants · 1 Treatment Group

Primary Treatment: Durvalumab · No Placebo Group · Phase 2

durvalumab (MEDI4736)
Drug
Experimental Group · 1 Intervention: Durvalumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 36 months

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
3,989 Previous Clinical Trials
91,527,816 Total Patients Enrolled
Georgetown UniversityLead Sponsor
320 Previous Clinical Trials
120,672 Total Patients Enrolled
Chul Kim, MDStudy ChairGeorgetown University
2 Previous Clinical Trials
17 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Those in cohort 1 who meet the above criteria must be on an effective combination anti-retroviral therapy (cART) regimen for ≥ 4 weeks in order to be eligible
A blood test result that shows an absolute neutrophil count (ANC) of 1,000 per mm3 or higher.
If your platelet count is at least 100,000 per cubic millimeter, your risk for a bleeding complication is low.
A CD4 T-cell count of ≥100 per mm3 is considered normal for HIV-infected patients.
This policy states that patients with serum bilirubin levels below 1.5 times the institutional upper limit of normal will not be excluded from the study
You must be at least 18 years old to participate in this study.
The Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 means the person is fully active and has no symptoms.
This study included patients with stage IV NSCLC who had not received any previous systemic therapy for their cancer.
You have a hemoglobin level of at least 9.0 g/dL.
References

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