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Atezolizumab + Radiation Therapy for Lung Cancer

Phase 3
Recruiting
Led By Megan E Daly
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must be >= 18 years old
Patient must have adequate liver function defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x institutional upper level of normal (IULN) within 28 days prior to randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is testing whether adding atezolizumab to radiation therapy works better than just radiation therapy alone in treating patients with early non-small cell lung cancer.

Who is the study for?
This trial is for adults with early-stage non-small cell lung cancer (NSCLC) who haven't had previous treatment. Participants must be medically inoperable or unwilling to undergo surgery, have no significant heart disease, active hepatitis B/C or tuberculosis, and not be pregnant. They should not have received recent immunosuppressive treatments and must agree to use effective contraception.Check my eligibility
What is being tested?
The study tests adding Atezolizumab, an immune system-boosting drug, to standard radiation therapy compared to radiation alone. The goal is to see if combining these treatments improves outcomes for patients with stage I-IIA NSCLC by helping the body's own immune system fight cancer more effectively.See study design
What are the potential side effects?
Potential side effects of Atezolizumab include reactions related to the immune system such as inflammation in various organs, infusion-related reactions which can range from mild discomfort to severe symptoms at the site of injection, fatigue, digestive issues like nausea or diarrhea, blood disorders that may affect clotting or immunity levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My liver tests are within the normal range.
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I do not have serious heart disease.
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I can take care of myself and am up and about more than 50% of my waking hours.
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I have been tested for hepatitis C recently and do not have an active infection.
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I have not had a heart attack in the last 90 days.
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I don't have a history of serious lung disease or current lung inflammation.
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I have not received any treatment for my current lung cancer diagnosis.
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I do not have active tuberculosis.
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I cannot have surgery for my condition as decided by a surgeon or medical team, or I choose not to have surgery.
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My cancer is aggressive, based on size, PET scan results, or cell type.
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I haven't had a severe infection in the last 28 days.
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I do not have irregular heartbeats or chest pain that is getting worse.
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I don't have severe allergies to specific medical treatments or their components.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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
Overall survival
Secondary outcome measures
Incidence of adverse events
Progression free survival
Other outcome measures
Change in health-related quality of life

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446
87%
Fatigue
53%
Nausea
33%
Cough
27%
Depression
27%
Pain
27%
Anemia
27%
Dyspnea
27%
Lymphocyte count decreased
27%
Platelet count decreased
27%
Fall
20%
Chest pain
20%
Chills
20%
Neutropenia
20%
Diarrhea
20%
Dizziness
20%
Edema limbs
13%
Constipation
13%
Dysgeusia
13%
Skin infection
13%
Back pain
13%
Dysesthesia
13%
Rash
13%
Myalgia
13%
Edema
13%
Delirium
13%
Weakness (limb)
13%
Tinnitus
13%
Vomiting
13%
Weight loss
13%
Insomnia
7%
Tremor
7%
Proteinuria
7%
Lung infection
7%
Amnesia
7%
Hypoxia
7%
Urinary frequency
7%
Seizures
7%
Hearing loss
7%
Hypoxic respiratory failure
7%
Allergy (seasonal)
7%
Urinary urgency
7%
Erythema multitforme
7%
Encephalopathy
7%
Acute kidney injury
7%
Dysphagia
7%
Lymphocytopenia
7%
Febrile Neutropenia
7%
Cognitive disturbance
7%
Nasal congestion
7%
Neutrophil count decreased
7%
Headaches
7%
Hearing impaired
7%
Bruising
7%
Death NOS
7%
Muscle weakness
7%
Sneezing
7%
Hypertension
7%
Pleural effusion
7%
Photophobia
7%
Anorexia
7%
Anxiety
7%
Creatinine increased
7%
Hypokalemia
7%
Hypomagnesemia
7%
Parathesia (tingling)
7%
Sleep apnea
7%
Shingles
7%
Fever
7%
Gait disturbance
7%
Headache
7%
Hypernatremia
7%
Oral lesions
7%
Low white blood count
7%
Weakness (facial)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Maintenance Chemotherapy
Stereotactic Body Radiation Therapy

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (atezolizumab, SBRT)Experimental Treatment8 Interventions
Patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Starting on day 1 cycle 3, patients also undergo SBRT for 3-8 treatments every 2 days or QD over 1-3 weeks. Patients undergo FDG-PET/CT during screening. Patients undergo blood sample collection and CT scans throughout the trial.
Group II: Arm B (SBRT)Active Control7 Interventions
Beginning 21 days after randomization, patients undergo SBRT for 3-8 treatments every 2 days or QD over 1-3 weeks. Patients undergo FDG-PET/CT during screening. Patients undergo blood sample collection and CT scans throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2008
Completed Phase 2
~2210
Computed Tomography
2017
Completed Phase 2
~2720
Atezolizumab
2017
Completed Phase 3
~5860
Biospecimen Collection
2004
Completed Phase 2
~1720
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,958,921 Total Patients Enrolled
Megan E DalyPrincipal InvestigatorSWOG Cancer Research Network
~235 spots leftby May 2028