What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) using immune checkpoint inhibitors like Atezolizumab, Pembrolizumab, and Nivolumab are associated with several side effects. These include immune-related adverse events such as pneumonitis, which can occur in approximately 5% of patients, with severe cases in about 2%. Other common side effects include fatigue, rash, diarrhea, and pruritus. Severe (grade 3 or higher) treatment-related adverse effects are less frequent but can include conditions like severe pneumonitis, colitis, hepatitis, and endocrinopathies. The overall incidence of severe adverse events varies, with some studies reporting rates around 27% for Pembrolizumab and 22% for Atezolizumab.

What prior FDA approvals exist?

Atezolizumab, an anti-PD-L1 monoclonal antibody, is FDA-approved for the treatment of metastatic NSCLC in patients whose disease has progressed during or following platinum-containing chemotherapy. Pembrolizumab, an anti-PD-1 antibody, is approved for tumors expressing PD-L1 (≥1% of tumor cells) in previously treated advanced NSCLC and as a first-line treatment for tumors with high PD-L1 expression (≥50%). Nivolumab, another anti-PD-1 antibody, is approved for advanced NSCLC after progression on platinum-based chemotherapy, regardless of PD-L1 expression. These approvals highlight the role of immune checkpoint inhibitors in managing NSCLC.

What other types of research exist?

Promising alternatives to Atezolizumab for NSCLC patients include Pembrolizumab (anti-PD-1) and Nivolumab (anti-PD-1), both of which have shown improved outcomes in combination with chemotherapy. Additionally, Durvalumab (anti-PD-L1) combined with Tremelimumab (anti-CTLA-4) and chemotherapy is another novel option. These alternatives have demonstrated efficacy in various clinical trials and are considered viable options for NSCLC treatment.

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PD-L1 Inhibitor

Subcutaneous vs Intravenous Atezolizumab for Lung Cancer

Phase 2

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

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

Must have

For Participants with Stage IV NSCLC: No prior systemic treatment for Stage IV non-squamous or squamous NSCLC

For Participants with Early-stage NSCLC: Complete resection of a histologically or cytologically confirmed Stage II, IIIA, and selected IIIB (T3-N2) NSCLC

Must not have

For All Participants: History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan

For Participants with Stage IV NSCLC: Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two ways of giving a cancer drug called atezolizumab to adults with certain types of lung cancer. Atezolizumab is an immune checkpoint inhibitor approved for use with chemotherapy for treating extensive-stage small cell lung cancer. The study aims to find out if patients and healthcare providers prefer the drug given as an injection under the skin or through an IV. Atezolizumab helps the immune system fight cancer by blocking a protein that lets cancer cells hide.

Who is the study for?

This trial is for adults with PD-L1-positive NSCLC. It includes those who've completed adjuvant chemotherapy after lung cancer surgery and haven't relapsed, as well as those with Stage IV NSCLC who haven't had systemic treatment. Participants should have a life expectancy of at least 18 weeks, be in good physical condition (ECOG 0 or 1), and meet specific criteria related to their cancer stage and treatments received.

What is being tested?

The study compares patient and healthcare professional preferences between two ways of giving Atezolizumab: a shot under the skin (subcutaneous) versus directly into a vein (intravenous). The goal is to see which method people prefer for treating non-small cell lung cancer.

What are the potential side effects?

Atezolizumab can cause side effects like fatigue, nausea, fever, infections, potential allergic reactions during infusion, shortness of breath, rash or itching. More serious but less common side effects include inflammation of organs such as lungs or intestines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have stage IV NSCLC and haven't received systemic treatment for it.

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I had surgery to remove early-stage lung cancer.

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My early-stage lung cancer shows some PD-L1 activity.

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My advanced lung cancer shows high PD-L1 levels.

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I am fully active or can carry out light work.

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My lung cancer is confirmed to be Stage IV, either non-squamous or squamous.

Exclusion Criteria

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

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I have had lung conditions like pulmonary fibrosis or pneumonitis.

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I have lung cancer that has spread to my brain and is causing symptoms or getting worse.

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I have or had an autoimmune disease or immune deficiency.

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I frequently need procedures to remove excess fluid from my body.

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I have cancer pain that is not relieved by treatment.

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My cancer has a specific genetic change in the EGFR gene or ALK gene.

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I have high calcium levels in my blood that are causing symptoms.

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I have had leptomeningeal disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 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

Percentage of Participants Who Preferred Atezolizumab SC to Atezolizumab IV Assessed Using Patient Preference Questionnaire (PPQ)

Secondary study objectives

Change From Baseline Over Time in Health-related Quality of Life (HRQoL) Score as Assessed by GHS/QoL Scale of the EORTC-QLQ-C30

Change From Baseline Over Time in Participant Functioning as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30)

Change From Baseline Over Time in Symptoms as Assessed by EORTC-QLQ-C30

+11 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

Fatigue

35%

Alopecia

24%

Diarrhoea

23%

Nausea

23%

Decreased appetite

22%

Anaemia

20%

Asthenia

19%

Cough

19%

Dyspnoea

16%

Myalgia

15%

Neutropenia

14%

Constipation

14%

Oedema peripheral

12%

Pyrexia

11%

Stomatitis

11%

Vomiting

11%

Neuropathy peripheral

10%

Arthralgia

Neutrophil count decreased

Rash

Dysgeusia

Headache

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Febrile neutropenia

Pneumonia

Lacrimation increased

Abdominal pain

Dry skin

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment BExperimental Treatment1 Intervention

Participants will receive atezolizumab IV followed by atezolizumab SC.

Group II: Treatment AExperimental Treatment1 Intervention

Participants will receive atezolizumab SC followed by atezolizumab IV.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

0 / 14Eligibility 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 immune checkpoint inhibitors like Atezolizumab, which is an anti-PD-L1 monoclonal antibody. Atezolizumab works by blocking the PD-L1 protein on cancer cells, preventing it from binding to the PD-1 receptor on T-cells. This inhibition allows T-cells to recognize and attack cancer cells more effectively. Other treatments include chemotherapy, which uses drugs to kill rapidly dividing cancer cells, and targeted therapies that focus on specific genetic mutations within cancer cells. These treatments are crucial for NSCLC patients as they can improve survival rates, reduce tumor size, and enhance the quality of life by leveraging the body's immune system and targeting cancer at a molecular level.