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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
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

MDT-BRIDGE Trial 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.Check my eligibility
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.See study design
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.

MDT-BRIDGE Trial Eligibility Criteria

Inclusion Criteria

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

MDT-BRIDGE Trial 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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study intervention until death, withdrawal of consent, or the end of the study (approximately 3.5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Event-free survival (EFS)
Event-free survival (EFS) rate
Number of participants with adverse events
+17 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
8%
Edema limbs
8%
Fever
8%
Anal pain
8%
Dry skin
8%
Colitis
8%
Thromboembolic event
8%
Dry mouth
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Urinary tract pain
8%
Urinary frequency
8%
Small intestinal obstruction
5%
Anemia
5%
Ascites
5%
Confusion
5%
Pneumonitis
5%
Sinus bradycardia
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Memory impairment
5%
Vaginal hemorrhage
5%
Hypomagnesemia
5%
Upper respiratory infection
5%
Mucositis oral
5%
Rash acneiform
5%
Urinary urgency
5%
Gastroesophageal reflux disease
5%
Lymphedema
3%
Rectal hemorrhage
3%
Colonic perforation
3%
Generalized muscle weakness
3%
Hyperkalemia
3%
Lethargy
3%
Myocarditis
3%
Fall
3%
Skin infection
3%
Hypothyroidism
3%
Muscle weakness left-sided
3%
Alanine aminotransferase increased
3%
Hyperglycemia
3%
Pleural effusion
3%
Creatinine increased
3%
Rectal pain
3%
Aspartate aminotransferase increased
3%
Dysarthria
3%
Myositis
3%
CPK increased
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Left ventricular systolic dysfunction
3%
Weight Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab

MDT-BRIDGE 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
~3870

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,272 Previous Clinical Trials
288,612,535 Total Patients Enrolled

Frequently Asked Questions

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

Is this research protocol accessible to those above the age of eighty-five?

"The age requirement for this study necessitates that participants are older than 18 years of age and younger than 130."

Answered by AI

How pervasive is the implementation of this research within the United States?

"This medical study is now taking in participants at 39 various sites, located in Klagenfurt, Wien and Montreal as well as 36 other cities. It may be beneficial to find the closest clinic when applying for enrollment to limit travel needs."

Answered by AI

Is Durvalumab a secure medication for individuals?

"Durvalumab's safety is thought to be moderate, as the drug has yet to demonstrate efficacy in clinical studies and only achieved a score of 2."

Answered by AI

Is the participant recruitment process for this investigation still open?

"Clinicaltrials.gov shows that this trial is not currently actively recruiting participants; the initial posting was made on December 31st 2023, with the last update being October 27th of that same year. A total of 2015 other clinical studies are still searching for volunteers at present."

Answered by AI

Would I meet the requirements to partake in this medical experiment?

"This clinical trial is seeking 140 individuals suffering from non-small cell lung cancer, all aged between 18 and 130. Each participant must meet certain criteria to be eligible for the study such as being medically operable with adequate cardiac and lung function, having a minimum life expectancy of 12 weeks, possessing an EGFR and ALK wild-type status, weighing at least 30kgs.,and having their nodal status confirmed via whole body FDG-PET scans and biopsies."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study to Assess Neoadjuvant Durvalumab (D) and Platinum-Based Chemotherapy (CT), Followed by Either Surgery and Adjuvant D or CRT and Consolidation D, in Resectable or Borderline Resectable Stage IIB-IIIB NSCLC (MDT-BRIDGE)
2024. "Study to Assess Neoadjuvant Durvalumab (D) and Platinum-Based Chemotherapy (CT), Followed by Either Surgery and Adjuvant D or CRT and Consolidation D, in Resectable or Borderline Resectable Stage IIB-IIIB NSCLC (MDT-BRIDGE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05925530.
~93 spots leftby Apr 2026
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