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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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%

Anemia

27%

Pain

27%

Fall

27%

Dyspnea

27%

Depression

27%

Lymphocyte count decreased

27%

Platelet count decreased

20%

Chills

20%

Dizziness

20%

Chest pain

20%

Neutropenia

20%

Diarrhea

20%

Edema limbs

13%

Skin infection

13%

Dysesthesia

13%

Insomnia

13%

Edema

13%

Constipation

13%

Delirium

13%

Dysgeusia

13%

Vomiting

13%

Tinnitus

13%

Rash

13%

Myalgia

13%

Back pain

13%

Weakness (limb)

13%

Weight loss

Proteinuria

Bruising

Hearing loss

Anxiety

Oral lesions

Headaches

Acute kidney injury

Hypokalemia

Lymphocytopenia

Seizures

Weakness (facial)

Hearing impaired

Hypernatremia

Neutrophil count decreased

Death NOS

Hypertension

Headache

Creatinine increased

Fever

Pleural effusion

Gait disturbance

Nasal congestion

Tremor

Urinary urgency

Amnesia

Photophobia

Urinary frequency

Dysphagia

Low white blood count

Sneezing

Cognitive disturbance

Erythema multitforme

Lung infection

Allergy (seasonal)

Muscle weakness

Hypomagnesemia

Parathesia (tingling)

Febrile Neutropenia

Anorexia

Hypoxic respiratory failure

Sleep apnea

Encephalopathy

Hypoxia

Shingles

100%

80%

60%

40%

20%

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

~2790