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Durvalumab + Chemotherapy for Lung Cancer (MDT-BRIDGE Trial)
Phase 2
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Previously untreated and pathologically confirmed Stage IIB to select [i.e.N2] Stage IIIB by AJCC v8
Deemed resectable or borderline resectable at baseline, confirmed by MDT evaluation at diagnosis
Must not have
Participants contraindicated for surgical intervention due to comorbid conditions
Female participants who are pregnant or breastfeeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of study intervention until death, withdrawal of consent, or the end of the study (approximately 3.5 years)
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a drug combo to treat lung cancer before surgery, chemo, or radiotherapy, and afterwards.
Who is the study for?
This trial is for adults over 18 with Stage IIB-IIIB NSCLC that hasn't been treated yet. They must be able to have surgery, not have certain gene mutations (EGFR/ALK), and agree to use birth control. Pregnant or breastfeeding women, those allergic to the drug being tested, or with other primary tumors can't join.
What is being tested?
The study tests Durvalumab combined with chemotherapy before cancer surgery in NSCLC patients. After initial treatment, participants will either go through surgery and more Durvalumab or chemoradiotherapy followed by additional doses of Durvalumab.
What are the potential side effects?
Durvalumab may cause immune-related reactions affecting various organs, infusion-related symptoms like fever or chills, tiredness, nausea, potential blood abnormalities and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is at Stage IIB to early Stage IIIB.
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My cancer is considered operable after team evaluation.
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My lymph node status was confirmed with specific imaging and biopsy techniques.
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I am a woman who can have children and my pregnancy test is negative.
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I weigh at least 30 kg.
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My heart and lungs are healthy enough for surgery.
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My cancer does not have mutations in the EGFR or ALK genes.
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I am 18 years old or older.
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My lung cancer diagnosis was confirmed through lab tests on tissue or fluid samples.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot have surgery because of other health conditions.
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I am not pregnant or breastfeeding.
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My planned surgery is to remove a small, wedge-shaped piece of my lung.
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My lung cancer cannot be removed by surgery as determined by a medical team.
Select...
My cancer is at stage IIIC.
Select...
I have been infected or tested positive for HIV.
Select...
My cancer has an EGFR mutation or ALK translocation.
Select...
I have been diagnosed with more than one primary cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose of study intervention until death, withdrawal of consent, or the end of the study (approximately 3.5 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study intervention until death, withdrawal of consent, or the end of the study (approximately 3.5 years)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Event-free survival (EFS)
Event-free survival (EFS) rate
Number of participants with adverse events
+17 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%
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
8%
Colitis
8%
Dry mouth
8%
Dry skin
8%
Fever
8%
Anal pain
8%
Edema limbs
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Small intestinal obstruction
8%
Thromboembolic event
8%
Urinary frequency
8%
Urinary tract pain
5%
Confusion
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Anemia
5%
Ascites
5%
Gastroesophageal reflux disease
5%
Hypomagnesemia
5%
Lymphedema
5%
Memory impairment
5%
Mucositis oral
5%
Pneumonitis
5%
Rash acneiform
5%
Sinus bradycardia
5%
Upper respiratory infection
5%
Urinary urgency
5%
Vaginal hemorrhage
3%
Alanine aminotransferase increased
3%
Aspartate aminotransferase increased
3%
Alkaline phosphatase increased
3%
Colonic perforation
3%
Dysarthria
3%
Blood bilirubin increased
3%
CPK increased
3%
Creatinine increased
3%
Myositis
3%
Rectal hemorrhage
3%
Hypothyroidism
3%
Left ventricular systolic dysfunction
3%
Lethargy
3%
Muscle weakness left-sided
3%
Myocarditis
3%
Rectal pain
3%
Weight Loss
3%
Fall
3%
Generalized muscle weakness
3%
Hyperglycemia
3%
Hyperkalemia
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Pleural effusion
3%
Skin infection
100%
80%
60%
40%
20%
0%
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: DurvalumabExperimental Treatment1 Intervention
Durvalumab will be administered to the participants via intravenous infusion (IV)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3750
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,397 Previous Clinical Trials
289,121,547 Total Patients Enrolled
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