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Checkpoint Inhibitor
Atezolizumab + Stereotactic Body Radiation Therapy for Non-Small Cell Lung Cancer
Phase 1
Waitlist Available
Research Sponsored by Megan Daly, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a combination of a special drug and precise radiation therapy for patients with early-stage lung cancer who can't have surgery. The drug boosts the immune system, and the radiation directly attacks the tumor.
Eligible Conditions
- Nonsmall Cell Lung Cancer, Stage I
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum Tolerated Dose
Secondary study objectives
Disease free survival (DFS), assessed by RECIST 1.1 and irRECIST
Overall response rate (ORR), assessed by RECIST 1.1
Side effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
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%
Stomatitis
11%
Vomiting
11%
Neuropathy peripheral
10%
Arthralgia
9%
Neutrophil count decreased
9%
Rash
8%
Dysgeusia
8%
Headache
8%
Paraesthesia
7%
Pain in extremity
7%
Mucosal inflammation
7%
Back pain
7%
Peripheral sensory neuropathy
7%
Insomnia
6%
Febrile neutropenia
6%
Pneumonia
6%
Lacrimation increased
6%
Abdominal pain
6%
Dry skin
6%
Dizziness
5%
Malaise
5%
Urinary tract infection
5%
Weight decreased
5%
Haemoptysis
5%
Nail disorder
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
4%
Productive cough
3%
Upper respiratory tract infection
3%
Pruritus
2%
Influenza like illness
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
1%
Syncope
1%
Dehydration
1%
Atrial fibrillation
1%
Lower respiratory tract infection
1%
Lung infection
1%
Respiratory tract infection
1%
Acute kidney injury
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Depression
1%
Musculoskeletal chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: atezolizumab + SBRTExperimental Treatment2 Interventions
DOSE ESCALATION PHASE: Patients receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Within 24-48 hours after receiving atezolizumab, patients also undergo 4-5 fractions of stereotactic body radiation therapy over days 1-5 of course 3.
EXPANSION PHASE: Patients receive atezolizumab IV over 30-60 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Within 24-48 hours after receiving atezolizumab, patients also undergo 4-5 fractions of stereotactic body radiation therapy over days 1-5 of course 3.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~790
Atezolizumab
2016
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,565 Previous Clinical Trials
569,980 Total Patients Enrolled
Megan Daly, MDLead Sponsor
3 Previous Clinical Trials
80 Total Patients Enrolled
Karen KellyLead Sponsor
3 Previous Clinical Trials
66 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have one or more characteristics that indicate a higher risk for a certain condition.You have other health conditions that are not being properly managed or controlled.You can participate in the study even if you have a history of low thyroid hormone levels that is being treated with medication.You had a serious infection within the last 4 weeks before joining the study.You have a history of lung conditions called idiopathic pulmonary fibrosis, drug-induced pneumonitis, or organizing pneumonia.You have never had a serious allergic reaction to other types of medications called monoclonal antibodies.You have a history of a disease where your immune system attacks your own body.You do not currently have any other types of cancer.
Research Study Groups:
This trial has the following groups:- Group 1: atezolizumab + SBRT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.