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Checkpoint Inhibitor
Atezolizumab + Chemotherapy for Non-Small Cell Lung Cancer
Phase 2
Recruiting
Led By Nasser Hanna, MD
Research Sponsored by Nasser Hanna
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Squamous or non-squamous NSCLC histology. Cancers with a histology of "adenosquamous" are considered a type of adenocarcinoma and thus "non-squamous histology".
Patients must have undergone complete surgical resection of their stage I (tumors >= 4cm), IIA, IIB, and select stage III [any T1-3 N1-2 and T4N0-2] NSCLC according to the AJCC 8th edition with negative margins (R0).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing whether adding the immunotherapy drug atezolizumab to standard chemotherapy after surgery can help people with early-stage lung cancer live longer without their disease coming back.
Who is the study for?
This trial is for adults who've had surgery to remove certain stages of non-small cell lung cancer and have detectable ctDNA, indicating a risk of recurrence. They must be in good health with proper organ function, not pregnant or breastfeeding, willing to use contraception, and haven't received prior treatments for this cancer. People with other active cancers, severe allergies to atezolizumab or its components, autoimmune diseases, infections like HIV or hepatitis B/C are excluded.Check my eligibility
What is being tested?
The study tests if adding the drug Atezolizumab to standard chemotherapy after surgery can prevent cancer from coming back in patients with specific stages of lung cancer who have signs of residual disease (ctDNA). It will check if clearing ctDNA from blood correlates with longer periods without disease and overall survival.See study design
What are the potential side effects?
Atezolizumab may cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), liver problems (hepatitis), skin reactions, hormonal gland issues (like thyroid disorders), infusion reactions; fatigue; potential worsening of pre-existing autoimmune conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is either squamous or non-squamous.
Select...
My lung cancer was surgically removed with clear margins.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of patients with undetectable ctDNA after 4 cycles of adjuvant chemotherapy + Atezolizumab plus up to 13 additional cycles of Atezolizumab in patients with stage I (tumors ≥ 4cm), IIA, IIB, and select stage III [any T1-3 N1-2 and T4N0-2]
Secondary outcome measures
1 year Disease Free Survival (DFS) in all patients
1 year Disease Free Survival (DFS) in patients with detectable ctDNA after 1 year of adjuvant therapy on study
1 year Disease Free Survival (DFS) in patients with no detectable ctDNA after 4 cycles of adjuvant chemotherapy + Atezolizumab who had detectable ctDNA after surgery.
+5 moreSide 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%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Peripheral sensory neuropathy
7%
Pain in extremity
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
Trial Design
2Treatment groups
Experimental Treatment
Group I: SC: Squamous cell tumorsExperimental Treatment3 Interventions
Atezolizumab 1200mg, Docetaxel 60-75 mg/m^2, Cisplatin 60-75 mg/m^2
Group II: NSC: Non-squamous cell tumorsExperimental Treatment3 Interventions
Atezolizumab 1200mg, Pemetrexed 500 mg/m^2, Cisplatin 60-75 mg/m^2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Pemetrexed
2014
Completed Phase 3
~5250
Docetaxel
1995
Completed Phase 4
~5620
Cisplatin
2013
Completed Phase 3
~1940
Find a Location
Who is running the clinical trial?
Nasser HannaLead Sponsor
3 Previous Clinical Trials
50 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,043 Total Patients Enrolled
Nasser Hanna, MD5.013 ReviewsPrincipal Investigator - Indiana University
Big Ten Cancer Research Consortium
6 Previous Clinical Trials
323 Total Patients Enrolled
5Patient Review
Dr. Hannah is truly the best of the best. They are so informative and take the time to explain your condition, treatment options, and what to expect. I would recommend them to anyone going through a cancer situation.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live vaccine in the last 30 days.I have not had chemotherapy, radiation, or immunotherapy for this lung cancer.I finished treatments for a previous cancer more than 3 months ago.My blood thinner medication dose is not stable.I have been treated with specific immune therapy targeting cancer.My lung cancer is either squamous or non-squamous.I have an active tuberculosis infection.I am 18 years old or older.You have uncontrolled high levels of calcium in your blood that is causing symptoms.I have or had an autoimmune disease like lupus, rheumatoid arthritis, or multiple sclerosis.I understand and can follow the study's procedures.My cancer does not have EGFR mutations or ALK rearrangements.I have been mostly active and able to carry out all my pre-disease activities up to a month ago.I haven't had major heart problems or strokes in the last 3 months.I don't need frequent procedures to remove excess fluid in my body.I do not have lung disease that causes symptoms or could affect drug side effect management.I have or had Hepatitis B or currently have Hepatitis C.I have had or currently have lung inflammation treated with steroids.You have been diagnosed with HIV in the past. Note: You don't need to be tested for HIV for this study.I haven't had a severe infection or been hospitalized for one in the last 4 weeks.I have had a transplant of stem cells or an organ from another person.I do not have any other active cancers.I have had cancer spread to the lining of my brain and spinal cord.My organ functions are within normal ranges as required.My cancer does not have small or large cell neuroendocrine features.My lung cancer was surgically removed with clear margins.I can provide a tissue sample for testing, either a block or slides.I agree to not have sex or to use a condom and not donate sperm.I am capable of becoming pregnant and have a recent negative pregnancy test.You have had serious allergic reactions to certain types of medications in the past.I had surgery for lung cancer less than 60 days ago.I am on high-dose steroids or other drugs that weaken my immune system.You have a very strong allergic reaction (Grade 3 or higher) to atezolizumab or any of its ingredients.
Research Study Groups:
This trial has the following groups:- Group 1: NSC: Non-squamous cell tumors
- Group 2: SC: Squamous cell tumors
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what ailments is Atezolizumab regularly prescribed?
"Atezolizumab is widely utilized to combat metastatic bladder cancer, but it has also been found useful for treating advanced directives, small cell lung cancer (SCLC), and testicular tumors."
Answered by AI
Is this experiment open for enrollment at the present time?
"The evidence on clinicaltrials.gov reveals that registration for this study is still open, which began on May 22nd 2020 and was last modified October 26th 2022."
Answered by AI
What is the current size of this experimental cohort?
"This clinical trial requires 100 participants that meet the predetermined criteria. Potential candidates can sign up at sites such as New york University Clinical Cancer Center in Manhattan and University of Virginia Health System in Charlottesville."
Answered by AI
What objectives are researchers hoping to accomplish with this clinical experiment?
"This clinical trial will measure its primary outcome, the percentage of patients with undetectable ctDNA after 4 cycles of adjuvant chemotherapy + Atezolizumab plus up to 13 additional cycles of Atezolizumab in those with stage I (tumors ≥4cm), IIA, IIB and select stage III [any T1-3 N1-2 and T4N0-2] NSCLC. Secondary outcomes include: the percentage of patients displaying clearance from ctDNA post four rounds of treatment; one year Disease Free Survival rate among those still showing detectable ctDNA"
Answered by AI
What have been the confirmed risks associated with Atezolizumab treatment?
"Our team at Power has evaluated the safety of Atezolizumab and determined it to be a 2 due to limited clinical evidence for its efficacy but some data indicating its security."
Answered by AI
In how many locations is this research investigation being conducted?
"Nine medical centres are participating in this trial, such as the New york University Clinical Cancer Center located in NY City, the renowned University of Virginia Health System based in Charlottesville and Ohio State University Comprehensive Cancer Centre stationed at Columbus. Additionally, there are a further six sites."
Answered by AI
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