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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights

Study Summary

This trial will compare two ways of taking atezolizumab (a cancer drug) in people with non-small cell lung cancer. The study will look at whether people prefer taking atezolizumab by injection under the skin or through a vein.

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.Check my eligibility
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.See study design
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.
Select...
I had surgery to remove early-stage lung cancer.
Select...
My early-stage lung cancer shows some PD-L1 activity.
Select...
My advanced lung cancer shows high PD-L1 levels.
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I am fully active or can carry out light work.
Select...
My lung cancer is confirmed to be Stage IV, either non-squamous or squamous.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Participants Who Preferred Atezolizumab SC to Atezolizumab IV
Secondary outcome measures
Change in Function, as Assessed by EORTC QLQ-C30 Scores
Change in Symptoms, as Assessed by EORTC QLQ-C30 Scores
Changes in Score in HRQoL
+7 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%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Peripheral sensory neuropathy
7%
Pain in extremity
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab

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
2017
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,089,710 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,427 Total Patients Enrolled

Media Library

Atezolizumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05171777 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Treatment A, Treatment B
Non-Small Cell Lung Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT05171777 — Phase 2
Atezolizumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05171777 — Phase 2

Frequently Asked Questions

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

What is the Atezolizumab drug's official status?

"Atezolizumab has not demonstrated efficacy in any clinical trials, however it has been shown to be safe in Phase 2 testing."

Answered by AI

How many people fit the bill for this research project?

"The trial is still recruiting patients, as the information on clinicaltrials.gov indicates. 18 different hospitals are looking for a total of 140 individuals to enroll in the study. The study was first posted on April 4th, 2020 and updated November 15th, 2020."

Answered by AI

Are new participants being accepted into this clinical trial at this time?

"The listing on clinicaltrials.gov indeed shows that this trial is ongoing and recruiting patients. It was originally posted on April 4th, 2022 and updated November 15th of the same year. The study needs 140 people in total, with 18 different locations advertising openings."

Answered by AI

Is this study limited to North American medical facilities?

"There are a total of 18 locations enrolling patients for this study, which include Lancaster, Spokane, Salt Lake City and 15 other sites. To reduce travel burden, it is advisable to select the clinical site nearest you."

Answered by AI

What was the outcome of earlier clinical trials that tested Atezolizumab?

"Atezolizumab's journey began in 2008 at Illinois Cancer Care. As of now, 356 active trials are being conducted and 79 have been completed. A significant amount of research is being performed out of Lancaster, South carolina."

Answered by AI

Atezolizumab is most often used to treat which condition?

"Atezolizumab is most often taken to treat small cell lung cancer, but it can also be used as a treatment for malignant neoplasms, non-small cell lung carcinoma, and postoperative patients."

Answered by AI

What are the precedents for this type of research?

"Atezolizumab is being tested in 356 different ongoing trials, located across 74 countries and 1665 cities. The first trial began in 2008, with 720 patients enrolled. This study completed Phase 2 drug approval stage, and since then 79 more studies have reached completion."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Participant and Healthcare Professional Reported Preference for Subcutaneous Atezolizumab Compared With Intravenous Atezolizumab Formulation in Participants With Non-Small Cell Lung Cancer
2022. "A Study to Evaluate Participant and Healthcare Professional Reported Preference for Subcutaneous Atezolizumab Compared With Intravenous Atezolizumab Formulation in Participants With Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05171777.
~57 spots leftby May 2025
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