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PD-L1 Inhibitor
Durvalumab for Lung Cancer (ATLANTIC Trial)
Phase 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged at least 18 years
Patient's tumour sample must be PD-L1 positive (≥25% of tumour cells with membrane staining (Cohort 1 and 2) or PD-L1 positive with ≥90% of tumour cells with membrane staining (Cohort 3)
Must not have
Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
Any unresolved toxicity CTCAE >Grade 2 from previous anti-cancer therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of first treatment until final dco (up to approximately 3 years 8 months)
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the effects of the drug durvalumab in patients with non small cell lung cancer that has spread to other parts of the body. The trial will assess how well the drug works, as well as its safety and tolerability.
Who is the study for?
This trial is for adults over 18 with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) who have already tried a platinum-based chemotherapy and one other treatment without success. They should be relatively healthy (WHO Performance Status of 0 or 1), expected to live more than 12 weeks, and their tumors must show certain levels of PD-L1 protein.
What is being tested?
The study tests the effects of MEDI4736 (Durvalumab), focusing on how well it works, its safety, and how tolerable it is for patients with NSCLC that's either locally advanced or has spread to other parts of the body.
What are the potential side effects?
Possible side effects include immune system reactions that can affect organs, infusion-related reactions similar to allergic responses, fatigue, digestive issues like diarrhea or constipation, skin problems like rash or itching, and potential increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My tumor is PD-L1 positive with specific levels of cell staining.
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My lung cancer is at an advanced stage (IIIB or IV).
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I am fully active or able to carry out light work.
Select...
My NSCLC has worsened after platinum-based chemo and another treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been treated with drugs targeting PD-1 or PD-L1 before.
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I don't have severe side effects from past cancer treatments.
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I do not have severe illnesses or uncontrolled diseases like active infections.
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I do not have uncontrolled heart issues or high blood pressure.
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I have had severe side effects from previous immunotherapy.
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I have or had Crohn's disease or ulcerative colitis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of first treatment until final dco (up to approximately 3 years 8 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of first treatment until final dco (up to approximately 3 years 8 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective Response Rate (ORR)
Secondary study objectives
Duration of Response (DoR)
Overall Survival (OS)
Time to Response (TTR)
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
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: MEDI4736Experimental Treatment1 Intervention
see below
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MEDI4736
2016
Completed Phase 3
~5560
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,411 Previous Clinical Trials
289,123,147 Total Patients Enrolled
Phillip Dennis, MD, PhDStudy DirectorAstraZeneca