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MEDI4736 for Lung Cancer

Q: What are the most common medical reasons to take MEDI4736?

<p>Conditions such as unresectable stage iii non-<a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">small cell lung cancer</a>, previously untreated metastatic ureter urothelial carcinoma, can all be improved with the use of MEDI4736.</p>

Phase 3

Waitlist Available

Research Sponsored by Canadian Cancer Trials Group

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6.7 years

Awards & highlights

Study Summary

This trial is testing whether a new drug, MEDI4736, is better than no further treatment after surgery for lung cancer.

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.Check my eligibility

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.See study design

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 below

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I am fully active or have some restrictions but can still care for myself.

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My lung cancer is confirmed to be non-small cell type.

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My cancer was classified as Stage IB (≥ 4cm), II, or IIIA after surgery.

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My lung cancer was completely removed by surgery with no remaining visible cancer.

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My liver and kidney functions are within normal ranges.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6.7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6.7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6.7 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

Compare Disease free survival (DFS) for patients with NSCLC that is PD-L1 expression TC ≥ 25% and patients without common activating EGFR mutations or ALK gene rearrangements

Secondary outcome measures

Compare Lung cancer specific survival for patients in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status

Compare overall survival (OS) for patients in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status

Determine survival benefits participants judge necessary to make adjuvant immunotherapy worthwhile

+7 more

Side effects data

From 2023 Phase 3 trial • 713 Patients • NCT02125461

36%

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

Pneumonitis

Nasopharyngitis

Insomnia

Musculoskeletal pain

Vomiting

Oedema peripheral

Myalgia

Dry skin

Hyperthyroidism

Anaemia

Bronchitis

Dizziness

Non-cardiac chest pain

Pain in extremity

Urinary tract infection

Hypertension

Hypokalaemia

Paraesthesia

Musculoskeletal chest pain

Lung infection

Atrial fibrillation

Myocardial infarction

Cardiac failure congestive

Sepsis

Herpes zoster

Chronic obstructive pulmonary disease

Acute kidney injury

100%

80%

60%

40%

20%

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

0 / 5Eligibility criteria met

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

165 Previous Clinical Trials

473,722 Total Patients Enrolled

Canadian Cancer Trials GroupLead Sponsor

124 Previous Clinical Trials

66,038 Total Patients Enrolled

Media Library

MEDI4736 Clinical Trial Eligibility Overview. Trial Name: NCT02273375 — Phase 3

Non-Small Cell Lung Cancer Research Study Groups: MEDI4736, Placebo

Non-Small Cell Lung Cancer Clinical Trial 2023: MEDI4736 Highlights & Side Effects. Trial Name: NCT02273375 — Phase 3

MEDI4736 2023 Treatment Timeline for Medical Study. Trial Name: NCT02273375 — Phase 3

Frequently Asked Questions

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

Can you give some examples of how MEDI4736 has been studied in the past?

"MEDI4736 was first studied in 2010 at City of Hope. Since then, a total of 18,371 clinical trials have been completed. As of now, 338 clinical trials are actively recruiting, with a majority of these trials taking place in Toronto and British Columbia."

Answered by AI

Has the FDA cleared MEDI4736 for use?

"MEDI4736's safety was given a 3 because there is some evidence of efficacy from phase 3 trials as well as multiple rounds of data that support safety."

Answered by AI

What are the most common medical reasons to take MEDI4736?

"Conditions such as unresectable stage iii non-small cell lung cancer, previously untreated metastatic ureter urothelial carcinoma, can all be improved with the use of MEDI4736."

Answered by AI

How many willing test subjects are part of this experiment?

"Currently, this clinical trial is not looking for new patients. The study was first posted on October 9th, 2014 and was most recently edited on March 2nd, 20212. For individuals seeking other studies, there are 2091 trials recruiting participants with non-small cell lung carcinoma (nsclc) and 338 studies for MEDI4736 actively recruiting participants."

Answered by AI

Are we still able to recruit people for this research project?

"Recruitment for this study is not open at the moment. This clinical trial was first posted on October 9th, 2014 and was most recently updated on March 2nd, 2022. For people looking for other trials, there are 2091 clinical trials actively searching for patients with non-small cell lung carcinoma (nsclc) and 338 trials for MEDI4736 actively enrolling participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Double Blind Placebo Controlled Controlled Study of Adjuvant MEDI4736 In Completely Resected NSCLC

2015. "Double Blind Placebo Controlled Controlled Study of Adjuvant MEDI4736 In Completely Resected NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02273375.

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