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Atezolizumab + Radiation Therapy for Lung Cancer

Phase 3
Waitlist Available
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
No Placebo-Only Group
Pivotal Trial

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.
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.
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall survival
Secondary study objectives
Incidence of adverse events
Progression free survival
Other study objectives
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%
Pain
27%
Dyspnea
27%
Depression
27%
Platelet count decreased
27%
Anemia
27%
Fall
27%
Lymphocyte count decreased
20%
Chills
20%
Dizziness
20%
Edema limbs
20%
Chest pain
20%
Neutropenia
20%
Diarrhea
13%
Edema
13%
Dysesthesia
13%
Dysgeusia
13%
Insomnia
13%
Constipation
13%
Delirium
13%
Skin infection
13%
Vomiting
13%
Tinnitus
13%
Myalgia
13%
Rash
13%
Back pain
13%
Weakness (limb)
13%
Weight loss
7%
Bruising
7%
Hearing loss
7%
Anxiety
7%
Headaches
7%
Acute kidney injury
7%
Hypokalemia
7%
Oral lesions
7%
Lymphocytopenia
7%
Neutrophil count decreased
7%
Weakness (facial)
7%
Seizures
7%
Hearing impaired
7%
Hypernatremia
7%
Hypoxic respiratory failure
7%
Creatinine increased
7%
Headache
7%
Death NOS
7%
Gait disturbance
7%
Nasal congestion
7%
Fever
7%
Tremor
7%
Urinary urgency
7%
Amnesia
7%
Photophobia
7%
Pleural effusion
7%
Proteinuria
7%
Urinary frequency
7%
Dysphagia
7%
Low white blood count
7%
Sneezing
7%
Cognitive disturbance
7%
Muscle weakness
7%
Erythema multitforme
7%
Lung infection
7%
Hypertension
7%
Allergy (seasonal)
7%
Hypomagnesemia
7%
Parathesia (tingling)
7%
Febrile Neutropenia
7%
Anorexia
7%
Sleep apnea
7%
Encephalopathy
7%
Hypoxia
7%
Shingles
100%
80%
60%
40%
20%
0%
Study treatment Arm
Maintenance Chemotherapy
Stereotactic Body Radiation Therapy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
2011
Completed Phase 2
~2200
Computed Tomography
2017
Completed Phase 2
~2740
Atezolizumab
2017
Completed Phase 3
~5850
Biospecimen Collection
2004
Completed Phase 3
~2020
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~790

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,886 Previous Clinical Trials
41,020,479 Total Patients Enrolled
Megan E DalyPrincipal InvestigatorSWOG Cancer Research Network
~219 spots leftby May 2028
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