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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
No history of severe hypersensitivity reactions to other monoclonal antibodies (mAbs)
One or more high-risk features identified:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing the combination of atezolizumab and stereotactic body radiation therapy (SBRT) to treat patients with stage I non-small cell lung cancer.

Eligible Conditions
  • Nonsmall Cell Lung Cancer, Stage I

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have never had a serious allergic reaction to other types of medications called monoclonal antibodies.
Select...
You have one or more characteristics that indicate a higher risk for a certain condition.
Select...
You do not currently have any other types of cancer.
Select...
You can participate in the study even if you have a history of low thyroid hormone levels that is being treated with medication.

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
Maximum Tolerated Dose
Secondary outcome measures
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 • NCT02008227
27%
Fatigue
25%
Decreased appetite
24%
Cough
19%
Dyspnoea
19%
Asthenia
18%
Constipation
18%
Pyrexia
18%
Nausea
16%
Diarrhoea
13%
Arthralgia
12%
Vomiting
12%
Anaemia
11%
Back pain
11%
Musculoskeletal pain
11%
Rash
10%
Headache
9%
Oedema peripheral
9%
Weight decreased
9%
Chest pain
9%
Insomnia
9%
Pruritus
9%
Pain in extremity
8%
Dizziness
7%
Upper respiratory tract infection
7%
Aspartate aminotransferase increased
7%
Myalgia
7%
Haemoptysis
6%
Influenza like illness
6%
Nasopharyngitis
6%
Alanine aminotransferase increased
6%
Bronchitis
6%
Productive cough
5%
Musculoskeletal chest pain
5%
Depression
5%
Dry skin
4%
Abdominal pain
4%
Urinary tract infection
4%
Neuropathy peripheral
4%
Paraesthesia
3%
Stomatitis
3%
Dysgeusia
3%
Pneumonia
2%
Malaise
2%
Pleural effusion
2%
Neutropenia
1%
Lacrimation increased
1%
Respiratory tract infection
1%
Sepsis
1%
Pneumonitis
1%
Mucosal inflammation
1%
Bone pain
1%
Pulmonary embolism
1%
Peripheral sensory neuropathy
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atezolizumab
Docetaxel

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
~780
Atezolizumab
2016
Completed Phase 3
~6040

Find a Location

Who is running the clinical trial?

Megan Daly, MDLead Sponsor
3 Previous Clinical Trials
80 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,660 Total Patients Enrolled
Karen KellyLead Sponsor
3 Previous Clinical Trials
66 Total Patients Enrolled

Media Library

Atezolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02599454 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: atezolizumab + SBRT
Non-Small Cell Lung Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT02599454 — Phase 1
Atezolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02599454 — Phase 1

Frequently Asked Questions

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

Has the Food and Drug Administration sanctioned Atezolizumab?

"Due to the early stages of this clinical trial, our team at Power assigned Atezolizumab a score of 1 on safety. This is because there are limited data points that assess efficacy and safety."

Answered by AI

Is this the inaugural endeavor of its kind?

"Atezolizumab has been under clinical investigations since 2008 when it was first sponsored by Hoffmann-La Roche. The initial study, involving 720 patients, earned the drug a Phase 2 approval. Currently, 350 active trials are being conducted across 74 countries and 1646 cities around the world."

Answered by AI

For what medical conditions is Atezolizumab typically prescribed?

"Atezolizumab is a viable medical option for treating small cell lung cancer, in addition to malignant neoplasms and non-small cell lung carcinoma. This medication can also provide relief from postoperative pain."

Answered by AI

How many participants are currently being administered treatment in this research endeavor?

"This clinical trial is no longer seeking new candidates. The study was initially published on February 1st 2016, and the last update was made on August 2nd 2022. For those searching for similar studies, 1909 medical trials recruiting participants with malignant neoplasms are available, along with 350 studies using Atezolizumab as an intervention actively enrolling patients."

Answered by AI

Is recruitment of participants ongoing for this experiment?

"Per clinicaltrials.gov, this study is no longer recruiting participants, despite being initially posted on February 1st 2016 and last updated August 2nd 2022. Although the trial has closed to new recruits, there are currently 2259 other studies actively searching for patient volunteers."

Answered by AI
~3 spots leftby Mar 2025