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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status of 0, 1
Histologically confirmed diagnosis of primary non-small cell carcinoma of the lung according to WHO Classification of Tumours
Must not have
Patients with synchronous primary tumours
Untreated and/or uncontrolled cardiovascular conditions, symptomatic cardiac dysfunction, or LVEF ≤ 50%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 years
Awards & highlights
Summary
This trial is testing whether a new drug, MEDI4736, can help lung cancer patients after surgery and possibly chemotherapy by boosting their immune system to fight any remaining cancer cells.
Who is the study for?
This trial is for adults with a confirmed diagnosis of non-small cell lung cancer (NSCLC) who have had surgery and possibly chemo. They should be in good physical condition (ECOG 0 or 1), have adequate blood counts, and organ function. It's not for those with certain neuroendocrine carcinomas, other cancers within the last 5 years, autoimmune diseases, severe allergies to MEDI4736, or uncontrolled health conditions.
What is being tested?
The study is testing whether taking the new drug MEDI4736 after surgery (and maybe chemo) helps more than no additional treatment at all. Participants are randomly assigned to get either MEDI4736 or a placebo without knowing which one they're getting—a process known as double-blind.
What are the potential side effects?
MEDI4736 might cause immune-related reactions since it affects the body's defense system. This can lead to inflammation in various organs like lungs and intestines, skin rashes, hormonal imbalances, fatigue and infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or have some restrictions but can still care for myself.
Select...
My lung cancer is confirmed to be non-small cell type.
Select...
My cancer was classified as Stage IB (≥ 4cm), II, or IIIA after surgery.
Select...
My lung cancer was completely removed by surgery with no remaining visible cancer.
Select...
My liver and kidney functions are within normal ranges.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have more than one primary cancer at the same time.
Select...
I have heart problems that are not being treated or controlled.
Select...
I am not currently taking any experimental drugs or cancer treatments.
Select...
I do not have active infections or serious illnesses like TB, hepatitis, HIV, lung issues, and I am not pregnant or breastfeeding.
Select...
I have been diagnosed with large-cell neuroendocrine carcinoma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Disease-free survival in the remaining 5 patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status
Evaluate the Quality of life in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status
Evaluate the nature, severity and frequency of adverse effects and tolerability of MEDI4736
Side effects data
From 2023 Phase 3 trial • 713 Patients • NCT0212546136%
Cough
24%
Fatigue
22%
Dyspnoea
18%
Diarrhoea
17%
Arthralgia
17%
Radiation pneumonitis
15%
Pyrexia
15%
Decreased appetite
14%
Nausea
13%
Pruritus
13%
Rash
12%
Upper respiratory tract infection
12%
Constipation
11%
Asthenia
11%
Hypothyroidism
11%
Headache
11%
Back pain
10%
Productive cough
10%
Pneumonia
9%
Pneumonitis
9%
Nasopharyngitis
9%
Insomnia
8%
Musculoskeletal pain
8%
Vomiting
8%
Oedema peripheral
8%
Myalgia
8%
Dry skin
7%
Hyperthyroidism
7%
Anaemia
7%
Bronchitis
7%
Dizziness
7%
Non-cardiac chest pain
7%
Pain in extremity
6%
Urinary tract infection
5%
Hypertension
5%
Hypokalaemia
5%
Paraesthesia
5%
Musculoskeletal chest pain
1%
Lung infection
1%
Atrial fibrillation
1%
Myocardial infarction
1%
Cardiac failure congestive
1%
Sepsis
1%
Herpes zoster
1%
Chronic obstructive pulmonary disease
1%
Acute kidney injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalumab (MEDI4736)
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MEDI4736Experimental Treatment1 Intervention
MEDI4736 by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier.
Group II: PlaceboPlacebo Group1 Intervention
PLACEBO by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MEDI4736
2016
Completed Phase 3
~5560
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include immunotherapy and chemotherapy. Immunotherapy, such as Durvalumab, works by blocking the interaction of PD-L1 with PD-1 and CD80, which enhances the immune system's ability to recognize and attack cancer cells.
This is crucial for NSCLC patients as it can lead to more durable responses and potentially improve survival rates. Chemotherapy, on the other hand, uses drugs to kill rapidly dividing cancer cells but can also affect normal cells, leading to significant side effects.
Combining these treatments can provide a more comprehensive approach, targeting cancer cells through different mechanisms and potentially improving outcomes for patients.
Locally Advanced, Unresectable Non-Small Cell Lung Cancer.
Locally Advanced, Unresectable Non-Small Cell Lung Cancer.
Find a Location
Who is running the clinical trial?
Australasian Lung Cancer Trials GroupOTHER
2 Previous Clinical Trials
190 Total Patients Enrolled
National Health and Medical Research Council, AustraliaOTHER
166 Previous Clinical Trials
475,462 Total Patients Enrolled
Canadian Cancer Trials GroupLead Sponsor
128 Previous Clinical Trials
67,689 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or have some restrictions but can still care for myself.You have a history of certain immune-related diseases or organ transplant.I have no cancer history in the last 5 years, except for non-melanoma skin cancer or in-situ cancer that was treated.I have N2 disease and will get radiation after surgery within the specified time.I have more than one primary cancer at the same time.Your white blood cell count and platelet count are within a certain range.I can start the treatment within 2 days after being selected.I have not received a live vaccine in the last 30 days.I have heart problems that are not being treated or controlled.My lung cancer was completely removed by surgery with no remaining visible cancer.My liver and kidney functions are within normal ranges.I do not have active infections or serious illnesses like TB, hepatitis, HIV, lung issues, and I am not pregnant or breastfeeding.My lung cancer is confirmed to be non-small cell type.My cancer was classified as Stage IB (≥ 4cm), II, or IIIA after surgery.I am not currently taking any experimental drugs or cancer treatments.I am receiving or have received chemotherapy before surgery.I have been diagnosed with large-cell neuroendocrine carcinoma.I have had platinum-based chemotherapy after surgery as recommended.You have had a bad reaction to MEDI4736 or any of its ingredients in the past.
Research Study Groups:
This trial has the following groups:- Group 1: MEDI4736
- 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.
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