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PD-L1 Inhibitor
Durvalumab for Non-Small Cell Lung Cancer (MERMAID-2 Trial)
Phase 3
Waitlist Available
Led By Charles Swanton
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Complete resection of the primary NSCLC
Histologically confirmed NSCLC with resectable stage II-III disease who have undergone curative intent therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2 years.
Awards & highlights
MERMAID-2 Trial Summary
This trial is testing a new drug, Durvalumab, to see if it is better than Placebo at treating stage II-III Non-Small Cell Lung Cancer in patients who are MRD-positive following curative intent therapy.
Who is the study for?
This trial is for adults who've had surgery to remove stage II-III Non-Small Cell Lung Cancer and are now cancer-free. They must have good organ function, not be pregnant or breastfeeding, willing to use birth control, and have no recent history of other cancers or immune diseases. People with certain genetic mutations or those on immunosuppressants can't join.Check my eligibility
What is being tested?
The study tests Durvalumab (a type of immunotherapy) against a placebo in patients who've completed surgery for lung cancer. It's double-blind, meaning neither the doctors nor the patients know who gets the real drug versus the placebo to ensure unbiased results.See study design
What are the potential side effects?
Durvalumab may cause immune-related side effects like inflammation in various organs, infusion reactions similar to allergic responses, fatigue, possible infections due to lowered immunity, and rarely conditions affecting hormones.
MERMAID-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer was completely removed by surgery.
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My lung cancer was removed with the goal of curing it.
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My surgical wounds have fully healed.
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My primary lung cancer has been completely surgically removed.
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I am 18 years old or older.
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My scans show no signs of cancer returning or spreading.
MERMAID-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 2 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To assess the efficacy of durvalumab compared to placebo as measured by DFS in all randomized patients. Outcomes measures were adjusted to align with the previous version of the protocol except for the changes according to the protocol amendment.
Secondary outcome measures
To assess the safety and tolerability profile of durvalumab monotherapy compared with placebo. Outcomes measures were adjusted to align with the previous version of the protocol except for the changes according to the protocol amendment.
Side effects data
From 2022 Phase 2 trial • 80 Patients • NCT0301512965%
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
MERMAID-2 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DurvalumabExperimental Treatment1 Intervention
Intravenous administration of Durvalumab
Group II: PlaceboPlacebo Group1 Intervention
Intravenous administration of placebo
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
4,259 Previous Clinical Trials
288,593,872 Total Patients Enrolled
Charles SwantonPrincipal InvestigatorFrancis Crick Institute
3 Previous Clinical Trials
953 Total Patients Enrolled
David SpigelPrincipal InvestigatorSCRI Development Innovations, LLC
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had extensive radiation to my bone marrow or wide field radiation in the last 4 weeks.I have or had an autoimmune or inflammatory disorder.I've had detailed scans of my chest, abdomen, and brain before surgery.I haven't had a blood transfusion within the last 4 months.I do not have any uncontrolled illnesses.I do not have an active infection like TB, hepatitis B or C, or HIV.I have received immunotherapy or been treated with durvalumab before.My surgical wounds have fully healed.My lung cancer was removed with the goal of curing it.I have not received a live vaccine in the last 30 days.I have not taken immunosuppressive drugs in the last 14 days.I am not willing to use birth control.My scans show clear signs of my cancer returning.I had cancer before, but it was treated over 5 years ago and there's no sign of it now.I can sign and agree to follow the study's rules.My lung cancer was completely removed by surgery.I am 18 years old or older.You have previously been assigned to receive the study drug in this study.I have had cancer within the last 5 years.I am not pregnant or breastfeeding.I have had an organ or bone marrow transplant from another person.You have a history of a weak immune system that is not working properly.I am not currently on any cancer treatments like chemotherapy or hormone therapy.My samples are suitable for genetic and PD-L1 testing.I have signed a consent form for genetic testing.My primary lung cancer has been completely surgically removed.I am undergoing or have completed treatment aimed at curing my condition.I am 18 years old or older.You do not live in the United States.My cancer has EGFR or ALK mutations.My recent scans show no signs of cancer spread.My organs and bone marrow are working well.I have received radiation therapy before surgery.I have had a condition where lymphocytes grow abnormally.My scans show no signs of cancer returning or spreading.I have a history of cancer.My lung cancer is a mix of small cell and non-small cell types.I have recovered from all side effects of my previous treatments.The last blood sample collected during the 96-week period does not show evidence of minimal residual disease.I am pregnant or have become pregnant during the study.I have not had major surgery in the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Durvalumab
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals still able to join this ongoing research project?
"Currently, this particular trial is not looking for new patients. Although, this may change in the future as the last edit to the posting was on October 18th, 2022. If you are interested in other trials, there are 1557 clinical trials for carcinoma, non-small-cell lung and 338 studies for Durvalumab that are currently admitting patients."
Answered by AI
Can minors join this research project?
"In order to participate in this trial, potential patients must be aged 18 to 130. Out of the 33 clinical trials currently underway, this is the only one recruiting patients within this age range."
Answered by AI
Is Durvalumab a safe medication for human consumption?
"Durvalumab has received a score of 3 from our Power team. This is based on the fact that it is a Phase 3 clinical trial, meaning that there is both evidence of efficacy and multiple rounds of data supporting safety."
Answered by AI
How many different research facilities are overseeing this clinical trial?
"Currently, there are 36 enrolment sites for this study which are situated in locations including Ottawa, Silver Spring and Lincoln. If you wish to participate in this study, it would be advantageous to select a site near you to reduce travel costs and time."
Answered by AI
What are some of the primary health concerns that Durvalumab addresses?
"Durvalumab is most frequently used to treat unresectable stage iii non-small cell lung cancer. Other possible conditions that this drug could be used to treat include previously untreated, metastatic ureter urothelial carcinoma, and advance directives."
Answered by AI
What is the precedent for using Durvalumab in a clinical setting?
"Durvalumab was first studied in 2010 at City of Hope. As of now, there have been a total of 18,371 completed clinical trials. There are currently 338 clinical trials in progress, a majority of which are being conducted in Ottawa, Canada."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
Ohio
California
Other
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
What site did they apply to?
Research Site
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