What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) using immune checkpoint inhibitors like Durvalumab can lead to immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies (e.g., thyroid dysfunction), and skin reactions. When combined with chemotherapy, additional side effects may include neutropenia, febrile neutropenia, and hypertension. Severe side effects, including grade 3/4 toxicities and rare treatment-related deaths, can also occur.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of Non-Small Cell Lung Cancer (NSCLC). Pembrolizumab (Keytruda), an anti-PD-1 antibody, was approved for first-line treatment of metastatic NSCLC with high PD-L1 expression (≥50%) and for use in combination with chemotherapy regardless of PD-L1 status. Nivolumab (Opdivo), another anti-PD-1 antibody, is approved for previously treated advanced NSCLC. Atezolizumab (Tecentriq), an anti-PD-L1 antibody, is approved for first-line treatment in combination with chemotherapy for metastatic non-squamous NSCLC. These drugs work by blocking the interaction of PD-1/PD-L1, thereby enhancing the immune system's ability to target and destroy cancer cells.

What other types of research exist?

Promising alternatives to MEDI4736 (Durvalumab) for NSCLC patients include: 1) Pembrolizumab, which has shown significant overall survival (OS) and progression-free survival (PFS) benefits in combination with chemotherapy in the KEYNOTE-407 trial. 2) Cemiplimab, which has demonstrated improved OS and PFS in combination with platinum-based chemotherapy in preliminary results from a clinical trial. 3) Atezolizumab, particularly for patients with high PD-L1 expression, as it has shown OS benefits in combination with chemotherapy in the IMpower 131 trial. 4) The combination of Tremelimumab and Durvalumab plus chemotherapy, which has shown better OS and PFS compared to chemotherapy alone in the POSEIDON trial.

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MEDI4736 for Lung Cancer

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

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

Pivotal Trial

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have more than one primary cancer at the same time.

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I have heart problems that are not being treated or controlled.

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I am not currently taking any experimental drugs or cancer treatments.

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I do not have active infections or serious illnesses like TB, hepatitis, HIV, lung issues, and I am not pregnant or breastfeeding.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 years for reporting.

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 • 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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 / 10Eligibility criteria met

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.