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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

Study 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
79%
Cough
64%
Dyspnea
64%
Nausea
57%
Fatigue
43%
Constipation
36%
Pain
36%
Dizziness
29%
Anemia
29%
Back pain
29%
Vomiting
21%
Chest pain
21%
Anorexia
21%
Lymphocyte count decreased
21%
Death NOS
21%
Anxiety
21%
Fall
14%
Wheezing
14%
Dysphagia
14%
Hypotension
14%
Depression
14%
Diarrhea
14%
Platelet count decreased
14%
Abdominal Pain
14%
Edema
14%
Fever
14%
Headache
14%
Insomnia
14%
Palpitations
7%
Alopecia
7%
Creatinine increased
7%
Dehydration
7%
Otitis externa
7%
Sinusitis
7%
Dysgeusia
7%
Hemorrhoids
7%
Amnesia
7%
Confusion
7%
Dementia
7%
Productive cough
7%
Pneumonitis
7%
Dysuria
7%
White blood cell count decreased
7%
Throat pain
7%
Bone marrow biopsy
7%
Hearing impaired
7%
Rash
7%
Hypernatremia
7%
Eye pain
7%
Blurred vision
7%
Tachycardia
7%
Lung infection
7%
Neuropathy
7%
Hypertension
7%
Pleuritic pain
7%
Neutropenia
7%
Hypoxia
7%
Aspiration pneumonia
7%
Blood bilirubin increased
7%
Muscle weakness
7%
Tremor
7%
Weight loss
7%
Thrombocytopenia
7%
Floaters
7%
Toothache
7%
Esophagitis
7%
Leukocytosis
7%
Edema limbs
7%
Gait disturbance
7%
Parathesia (tingling)
7%
Edema face
7%
COPD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Body Radiation Therapy
Maintenance Chemotherapy

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
~2240
Computed Tomography
2017
Completed Phase 2
~2720
Atezolizumab
2017
Completed Phase 3
~5860
Biospecimen Collection
2004
Completed Phase 2
~1700
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,666 Previous Clinical Trials
40,925,525 Total Patients Enrolled
Megan E DalyPrincipal InvestigatorSWOG Cancer Research Network

Frequently Asked Questions

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

Are there any precedents for Stereotactic Body Radiation Therapy?

"Stereotactic Body Radiation Therapy was first researched in 2008 at Sint Augustinus Wilrijk, Apotheek. As of now, there is a total of 325 completed studies. There are presently 359 active trials, with many of these trials taking place in Pennington, New jersey."

Answered by AI

Is this study commonly conducted in North American medical facilities?

"Capital Health Medical Center-Hopewell in Pennington, New jersey, Kaiser Permanente Cancer Treatment Center in South San Francisco, California, and Kaiser Permanente-Oakland in Oakland, Nebraska are all participating locations in this study. There are also 100 other sites where this treatment is available."

Answered by AI

What type of cancer is Stereotactic Body Radiation Therapy usually used to treat?

"Stereotactic Body Radiation Therapy is commonly used to target small cell lung cancer (sclc), but it can also be an effective intervention for other conditions like malignant neoplasms and non-small cell lung carcinoma."

Answered by AI

Does this research project have any available openings for participants?

"Yes, this trial is still looking for participants according to the website clinicaltrials.gov. The listing was first posted on March 25th, 2020 and was edited most recently on November 4th, 2020."

Answered by AI

Has this kind of trial been done before?

"As of now, there are 359 ongoing clinical trials for Stereotactic Body Radiation Therapy in 1665 cities and 74 countries. The first such trial started in 2008 and was sponsored by Genentech, Inc. It completed its Phase 2 drug approval stage with 720 participants. Since then, 325 similar studies have concluded."

Answered by AI

Does Stereotactic Body Radiation Therapy have any negative side effects on patients?

"There is a significant body of data supporting the safety of Stereotactic Body Radiation Therapy, as this treatment has been studied in multiple Phase 3 clinical trials."

Answered by AI

How many individuals are being used for this research?

"Indeed, the posting on clinicaltrials.gov reveals that the trial is ongoing and is currently seeking 480 participants at 100 locations. The trial was originally posted on 3/25/2020 and was most recently edited on 11/4/2022."

Answered by AI

Who else is applying?

What site did they apply to?
Veterans Affairs Loma Linda Healthcare System
Medical Center of the Rockies
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

To be sure I dont get lung cancer back. To protect myself.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Testing the Addition of the Drug Atezolizumab to the Usual Radiation Treatment for Patients With Early Non-small Cell Lung Cancer
2020. "Testing the Addition of the Drug Atezolizumab to the Usual Radiation Treatment for Patients With Early Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04214262.
All > Alaska
~250 spots leftby May 2028
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