← Back to Search

PD-L1 Inhibitor

MEDI4736 (durvalumab) for Non-Small Cell Lung Cancer (ARCTIC Trial)

Phase 3

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until first progression. disease then assessed per local practice until 2nd progression. assessed up to a maximum of approximately 3 years.

Awards & highlights

ARCTIC Trial Summary

This trial is testing a new drug, MEDI4736, to see if it is better than the current standard of care for treating non-small cell lung cancer.

Eligible Conditions

Non-Small Cell Lung Cancer

ARCTIC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until first progression. disease then assessed per local practice until 2nd progression. assessed up to a maximum of approximately 3 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until first progression. disease then assessed per local practice until 2nd progression. assessed up to a maximum of approximately 3 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until first progression. disease then assessed per local practice until 2nd progression. assessed up to a maximum of approximately 3 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival (OS)

Progression-Free Survival (PFS)

Secondary outcome measures

Duration of Response (DoR)

OS, Contribution of the Components Analysis of Sub-study B

Objective Response Rate (ORR)

+5 more

Side effects data

From 2023 Phase 3 trial • 597 Patients • NCT02352948

26%

Decreased appetite

21%

Constipation

18%

Cough

18%

Nausea

18%

Dyspnoea

16%

Fatigue

15%

Pyrexia

15%

Headache

15%

Diarrhoea

13%

Vomiting

11%

Insomnia

11%

Arthralgia

11%

Pruritus

11%

Back pain

10%

Hypothyroidism

10%

Oedema peripheral

10%

Weight decreased

10%

Rhinorrhoea

10%

Musculoskeletal pain

10%

Dizziness

10%

Asthenia

Stomatitis

Hypokalaemia

Anaemia

Hyperkalaemia

Pneumonia

Haemoptysis

Gamma-glutamyltransferase increased

Abdominal pain

Non-cardiac chest pain

Viral upper respiratory tract infection

Dermatitis acneiform

Pleural effusion

Musculoskeletal chest pain

Rash

Neutrophil count decreased

Blood creatinine increased

Sepsis

Pulmonary embolism

Interstitial lung disease

Hyperthyroidism

Influenza

Myalgia

Pain in extremity

Subileus

Pneumocystis jirovecii pneumonia

Pulmonary sepsis

Overdose

Deep vein thrombosis

Alanine aminotransferase increased

Cardiac failure

Inappropriate antidiuretic hormone secretion

Colitis

Cholangitis

Humerus fracture

Hypercalcaemia

Pneumothorax

Epilepsy

Device dislocation

Haematuria

Respiratory failure

Hypotension

Thrombocytopenia

Platelet count decreased

Glucocorticoid deficiency

Myocardial infarction

Cytokine release syndrome

Muscular weakness

Acute respiratory failure

Abdominal pain upper

Malaise

Aspartate aminotransferase increased

White blood cell count decreased

Dehydration

100%

80%

60%

40%

20%

Study treatment Arm

Sub-study A: Durvalumab

Sub-study A: SoC

Sub-study B: Durvalumab+Tremelimumab

Sub-study B: Tremelimumab

Sub-study B: SoC

Sub-study B: Durvalumab

ARCTIC Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: tremelimumab in Sub-study BExperimental Treatment1 Intervention

tremelimumab by intravenous infusion. Sub-study B for patients with PD-L1 negative tumors.

Group II: MEDI4736 (durvalumab) monotherapy in Sub-study BExperimental Treatment1 Intervention

MEDI4736 (durvalumab) by intravenous infusion. Sub-study B for patients with PD-L1 negative tumors.

Group III: MEDI4736 (durvalumab) monotherapy in Sub-study AExperimental Treatment1 Intervention

MEDI4736 (durvalumab) by intravenous infusion. Sub-study A for patients with PD-L1 positive tumors.

Group IV: MEDI4736 (durvalumab) + tremelimumab in Sub-study BExperimental Treatment1 Intervention

MEDI4736 (durvalumab) by intravenous infusion and tremelimumab by intravenous infusion. Sub-study B for patients with PD-L1 negative tumors.

Group V: Standard of Care in Sub-study AActive Control3 Interventions

Investigator choice from Vinorelbine, Gemcitabine and Erlotinib. Sub-study A for patients with PD-L1 positive tumors.

Group VI: Standard of Care in Sub-study BActive Control3 Interventions

Investigator choice from Vinorelbine, Gemcitabine and Erlotinib. Sub-study B for patients with PD-L1 negative tumors.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MEDI4736 (durvalumab)

2015

Completed Phase 3

~600

MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4)

2015

Completed Phase 3

~600

tremelimumab (anti-CTLA4)

2015

Completed Phase 3

~600

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,257 Previous Clinical Trials

288,593,189 Total Patients Enrolled

Paul Stockman, MBChB, PhDStudy DirectorAstraZeneca

Frequently Asked Questions

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

What are the goals that this trial hopes to achieve?

"The primary outcome of this trial is Progression-Free Survival (PFS), which will be evaluated over a 36-month period. Secondary outcomes include Duration of Response (DoR), Percentage of Participants Alive at 12 Months (OS12), and Percentage of Participants Alive and Progression Free at 6 Months (APF6)."

Answered by AI

Where can people participate in this research?

"Currently, there are 34 different recruitment sites for this study, which are geographically located in places such as Saint Louis, Rockville and Battle Creek. If you are considering enrolling in the study, it would be beneficial to choose the site that is closest to you to limit travel."

Answered by AI

Does this research include patients above the age of 25?

"Patients that meet the age criteria of 18 or older, and no older than 130, are allowed to participate in this trial."

Answered by AI

Has the FDA cleared MEDI4736 (durvalumab) for use?

"Since this is a Phase 3 trial, there is available data that supports the efficacy and safety of MEDI4736 (durvalumab). Our team has rated the safety a 3 on a scale from 1 to 3."

Answered by AI

How effective has MEDI4736 (durvalumab) been in previous research?

"There are currently 864 clinical trials underway for MEDI4736 (durvalumab). Of those, 193 are in Phase 3. The majority of trials for MEDI4736 are based in Shanghai, but there are 38,485 locations running trials for this treatment."

Answered by AI

What are the most popular applications for MEDI4736 (durvalumab)?

"MEDI4736 (durvalumab) is the standard treatment for metastatic ureter urothelial carcinoma. It can also be used off-label to manage malignant neoplasms, recurrent cervical cancer, and locally advanced non-small cell lung cancer."

Answered by AI

Recent research and studies

Annals of OncologyJournal

ARCTIC: Durvalumab with or Without Tremelimumab as Third-line or Later Treatment of Metastatic Non-small-cell Lung Cancer

Planchard, D., N. Reinmuth, S. Orlov, J.R. Fischer, S. Sugawara, S. Mandziuk, D. Marquez-Medina, et al.. 2020. “ARCTIC: Durvalumab with or Without Tremelimumab as Third-line or Later Treatment of Metastatic Non-small-cell Lung Cancer”. Annals of Oncology. Elsevier BV. doi:10.1016/j.annonc.2020.02.006.

Quality of Life ResearchJournal

How Patients Being Treated for Non-small Cell Lung Cancer Value Treatment Benefit Despite Side Effects

Martin, Mona L., Julia Correll, Andrew Walding, and Anna Rydén. 2021. “How Patients Being Treated for Non-small Cell Lung Cancer Value Treatment Benefit Despite Side Effects”. Quality of Life Research. Springer Science and Business Media LLC. doi:10.1007/s11136-021-02882-6.

Quality of Life ResearchJournal

How Patients Being Treated for Non-small Cell Lung Cancer Value Treatment Benefit Despite Side Effects

clinicaltrials.govStudy

A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer