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PD-L1 Inhibitor
Atezolizumab + Tiragolumab for Non-Small Cell Lung Cancer and Advanced Solid Tumors
Phase 2
Waitlist Available
Research Sponsored by SCRI Development Innovations, LLC
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 6 months
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat patients with NSCLC or other advanced solid tumors who have failed to respond to other treatments.
Who is the study for?
Adults with NSCLC or advanced solid tumors previously treated with PD-1 inhibitors can join. They must have a certain level of physical fitness (ECOG score 0-2), adequate organ function, and agree to provide a tumor biopsy. Women who can bear children and men with partners who can must use effective contraception. Exclusions include uncontrolled diabetes, recent surgeries, severe allergies to similar drugs, active infections like Hepatitis B/C or HIV, and certain cardiovascular issues.Check my eligibility
What is being tested?
This Phase II trial has two parts: Arm A tests Atezolizumab combined with standard chemotherapy in NSCLC patients; Arm B tests Atezolizumab plus Tiragolumab in those with advanced solid tumors. Both arms are for those who've had prior PD-1 inhibitor treatment like nivolumab or pembrolizumab.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the drug components, infusion-related reactions from the antibodies used in treatment (Atezolizumab/Tiragolumab), potential blood disorders due to chemotherapy in Arm A, liver function changes, and increased risk of infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy (overall response rate [ORR])
Secondary outcome measures
Determine the disease control rate (DCR)
The incidence of serious adverse events (AEs) as a measure of safety
Therapeutic procedure
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%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Pain in extremity
7%
Peripheral sensory neuropathy
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: Arm B (Atezolizumab and Tiragolumab)Experimental Treatment2 Interventions
In Arm B, patients with advanced solid tumors will be treated with atezolizumab at a flat dose of 1200 mg IV every 3 weeks in combination with tiragolumab at a flat dose of 600 mg IV every 3 weeks until progression or unacceptable toxicity.
Group II: Arm A (Chemo + Atezolizumab)Experimental Treatment2 Interventions
In Arm A, patients with NSCLC will receive chemotherapy plus atezolizumab at a flat dose of 1200 mg intravenously (IV) every 3 weeks. Standard of care chemotherapy is defined as a platinum-doublet therapy (or triplet if bevacizumab is used) of the Investigator's choice.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Tiragolumab
Not yet FDA approved
Find a Location
Who is running the clinical trial?
SCRI Development Innovations, LLCLead Sponsor
191 Previous Clinical Trials
13,483 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,609 Total Patients Enrolled
Melissa Johnson, MDStudy ChairSCRI Development Innovations, LLC
6 Previous Clinical Trials
802 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are able to perform daily activities and take care of yourself without assistance, or with some difficulty.You have enough infection-fighting white blood cells, unless you have a specific condition called benign ethnic neutropenia.You have received a transplant from another person (not your own tissues) in the past.You have non-small cell lung cancer and are eligible to participate in Arm A.You have an advanced form of solid tumors.Your liver enzyme levels (ALT and AST) are not more than 2.5 times the upper limit of normal.Your kidneys are functioning well, and your blood creatinine levels are not too high.Your platelet count needs to be at least 100,000 per microliter of blood within seven days of enrolling in the trial, without needing a blood transfusion.If you are a woman who could become pregnant, you agree to not have sex or use birth control that is very effective during the study and for 5 months after the last dose of the study drug.You have had other types of cancers within the last 5 years, except for certain types.Your personal, family, or social situation, or where you live, would make it difficult for you to follow the study's plan.If you have advanced solid tumors, you cannot participate in this study.You have a serious heart condition.You have too much fluid buildup in your chest, heart, or abdomen that needs to be drained frequently and cannot be controlled.You have severe and uncontrolled pain related to your tumor.Your hemoglobin level should be at least 9 g/dL. If it's lower, you may need a blood transfusion to participate.The investigator thinks that you have a medical condition or abnormal test results that make it unsafe for you to take the experimental drug or could make it difficult to interpret study results.You cannot participate if you have non-small cell lung cancer.You are required to use denosumab during the study.You may participate in the study even if you have brain lesions that are being treated or not causing any symptoms, as long as you meet other study criteria.You have taken medication to suppress your immune system within 2 weeks before starting the study or will need such medication during the study, unless there are specific exceptions.Your lymphocyte count needs to be at least 0.5 billion cells per liter (500 cells per microliter).Your bilirubin level (a substance produced by the liver) must be within a certain range. If you have Gilbert syndrome, a higher bilirubin level may be allowed.If you are not taking blood thinners, your blood clotting test results must be normal. If you are taking blood thinners, your medication must be stable.You have received a live vaccine within the past 4 weeks or are expected to receive one during the study or within 5 months after the last dose of atezolizumab or tiragolumab.You have a current or past history of an autoimmune disease or immune deficiency, except in certain cases.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (Atezolizumab and Tiragolumab)
- Group 2: Arm A (Chemo + Atezolizumab)
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.
Is this a widespread clinical trial or limited to just a few hospitals?
"To limit the burden of travel on patients, this study is enrolling at 7 sites near locations including Kansas City and Fort Myers. There are other enrolment centres located in Saint Petersburg and similar proximity."
Answered by AI
What are the most important goals of this research?
"According to the trial sponsor, Genentech, Inc., the main objective of this study is to evaluate the efficacy of combining atezolizumab with standard of care chemotherapy. The primary outcome measure will be overall response rate (ORR), which will be assessed over a period of up to 6 months. Secondary outcome measures include disease control rate (DCR), defined as the proportion of patients with CR, PR, or SD for at least 6 months according to the immune-modified RECIST criteria; incidence of serious adverse events (AEs) as a measure of safety; and overall survival (OS). OS will be"
Answered by AI
Could you please give us a brief overview of other clinical trials that have included Atezolizumab?
"Atezolizumab was first studied in 2008 at Illinois Cancer Care. So far, 79 clinical trials have been completed and 356 are recruiting patients with a majority based out of Kansas City, Missouri."
Answered by AI
What is the primary purpose of this clinical trial?
"Atezolizumab was first trialled in 2008, with the support of Hoffmann-La Roche. After this initial study of 720 participants, Atezolizumab entered Phase 2 clinical trials and was approved for use. Currently, there are 356 active studies being conducted in 1665 cities across 74 countries."
Answered by AI
What type of cancer has Atezolizumab been most successful in treating?
"Atezolizumab is a potential treatment for small cell lung cancer (sclc), malignant neoplasms, and non-small cell lung carcinoma."
Answered by AI
Are there any recorded dangers of Atezolizumab?
"Atezolizumab is a medication that, according to our team's research, falls on the second tier of safety. This is because, although there are studies supporting its safety profile, none have been done to test for efficacy."
Answered by AI
Are there any more patients needed for this clinical trial?
"The correct answer is that this clinical trial, as indicated by information on clinicaltrials.gov, is actively recruiting patients. This study was originally posted on 8/30/2019, with the most recent edit taking place on 2/16/2022. They are currently enrolling 80 patients from 7 different sites."
Answered by AI
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