What side effects are associated with this type of intervention?

Common treatments for NSCLC, including PD-L1 inhibitors like Durvalumab, often result in immune-related side effects such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. When combined with chemotherapy, additional side effects include nausea, fatigue, anemia, neutropenia, and increased risk of infections. Dual checkpoint inhibition (e.g., Durvalumab with Tremelimumab) can lead to higher rates of severe immune-related adverse events. Overall, the combination of immunotherapy and chemotherapy tends to increase the frequency and severity of side effects compared to monotherapy.

What prior FDA approvals exist?

Several PD-1/PD-L1 inhibitors have received FDA approval for the treatment of NSCLC. Pembrolizumab (Keytruda) is approved for use in combination with chemotherapy for both squamous and non-squamous NSCLC, showing improved overall survival and progression-free survival. Atezolizumab (Tecentriq) is another PD-L1 inhibitor approved for use with chemotherapy in non-squamous NSCLC, also demonstrating significant survival benefits. Cemiplimab (Libtayo) is approved for advanced NSCLC with high PD-L1 expression. These approvals highlight the effectiveness of combining immunotherapy with chemotherapy in treating advanced NSCLC.

What other types of research exist?

Promising alternatives to Durvalumab for NSCLC patients include Pembrolizumab and Nivolumab, both of which are PD-1 inhibitors. Pembrolizumab has shown improved overall survival and progression-free survival in combination with chemotherapy for both squamous and non-squamous NSCLC. Nivolumab has demonstrated efficacy in patients with brain metastases and in combination with other treatments. Additionally, Atezolizumab, another PD-L1 inhibitor, has shown benefits in combination with chemotherapy, particularly in patients with high PD-L1 expression. Emerging therapies such as Lorlatinib for ALK-positive NSCLC and Osimertinib for EGFR-mutated NSCLC are also promising options.

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PD-L1 Inhibitor

Durvalumab vs Chemotherapy for Non-Small Cell Lung Cancer

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

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

PD-L1 high expression

Must not have

Brain metastases or spinal cord compression unless the patient is stable and off steroids for at least 14 days prior to start of study treatment

Active or prior documented autoimmune or inflammatory disorders (e.g., colitis or Crohn's disease)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing durvalumab, an immunotherapy drug, in patients with advanced lung cancer who do not have certain genetic mutations and have high levels of a specific protein. The drug helps the immune system see and fight the cancer better.

Who is the study for?

This trial is for adults with Stage IV Non-Small Cell Lung Cancer (NSCLC) who have not had prior treatment, do not have certain gene mutations (EGFR/ALK), and show high PD-L1 expression. It's not for those with a history of significant autoimmune diseases, untreated brain metastases, or previous immune therapy.

What is being tested?

The study compares the effectiveness and safety of Durvalumab alone versus various combinations of chemotherapy drugs in first-line treatment. Patients are randomly assigned to receive either Durvalumab or one of several standard chemo options.

What are the potential side effects?

Durvalumab may cause immune-related side effects like inflammation in different body parts, skin reactions, hormone gland problems, and infusion reactions. Chemotherapy can lead to hair loss, nausea, fatigue, increased risk of infection and blood cell changes.

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 restricted in physically strenuous activity but can do light work.

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My cancer shows high PD-L1 expression.

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I am 18 years old or older.

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My condition is Stage IV non-small cell lung cancer.

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My cancer does not have EGFR mutations or ALK rearrangements.

Exclusion Criteria

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

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I have stable brain or spinal metastases and haven't taken steroids for 14 days.

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I have or had an autoimmune or inflammatory disorder like colitis.

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I have not had chemotherapy or any systemic therapy for advanced NSCLC.

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My lung cancer is a mix of small-cell and non-small cell types.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

OS in Participants With LREM

Overall Survival (OS)

Secondary study objectives

APF12 in PD-L1 TC >= 25% LREM Analysis Set

APF12 in PD-L1 TC >= 50% Analysis Set

APF12 in PD-L1 TC >= 50% LREM Analysis Set

+39 more

Other study objectives

The Incidence of Treatment-Emergent Adverse Events assessed by Common Terminology Criteria for Adverse Event (CTCAE) v4.03 for subjects receiving Durvalumab therapy or SoC

Awards & Highlights

Pivotal Trial

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

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1: DurvalumabExperimental Treatment1 Intervention

Anti-PD-L1 monoclonal Antibody monotherapy

Group II: Arm 2: Standard of CareActive Control5 Interventions

Standard of Care Platinum-Based chemotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab (MEDI4736)

2018

Completed Phase 2

~50

0 / 9Eligibility 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 immunotherapies, chemotherapy, and targeted therapies. Immunotherapies, such as PD-L1 inhibitors like Durvalumab, work by blocking the PD-L1 protein on cancer cells, which helps the immune system recognize and attack these cells. This is crucial for NSCLC patients as it can enhance the body's natural defenses against cancer. Chemotherapy uses drugs to kill rapidly dividing cancer cells, but it also affects normal cells, leading to side effects. Targeted therapies focus on specific genetic mutations in cancer cells, such as EGFR or ALK mutations, and inhibit their growth and survival. These treatments are tailored to the genetic profile of the tumor, making them effective for certain subsets of NSCLC patients. Understanding these mechanisms helps in selecting the most appropriate treatment strategy, improving outcomes and minimizing side effects.