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Monoclonal Antibodies
Tiragolumab + Atezolizumab + Bevacizumab for Non-Small Cell Lung Cancer
Phase 2
Recruiting
Led By Joshua Reuss, MD
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years at time of signing ICF
Confirmed activating alteration in EGFR (cohort B only)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will test whether combining tiragolumab with atezolizumab and bevacizumab is more effective than atezolizumab and bevacizumab alone in treating advanced non-squamous NSCLC.
Who is the study for?
Adults with advanced non-squamous NSCLC that's progressed after treatment can join. They must have a certain level of PD-L1 expression, not be pregnant or breastfeeding, and agree to use contraception. People with severe heart disease, recent infections, prior TIGIT therapy, or uncontrolled hypertension are excluded.Check my eligibility
What is being tested?
The trial tests Tiragolumab combined with Atezolizumab and Bevacizumab in patients whose NSCLC has worsened despite previous treatments. It aims to assess the effectiveness of this combination therapy.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, bleeding issues due to Bevacizumab's effect on blood vessels, fatigue, liver function changes from Atezolizumab and infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My cancer has a specific EGFR mutation.
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My cancer does not have mutations in EGFR, ALK, or ROS1 genes.
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My advanced lung cancer cannot be treated with surgery or radiation.
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I agree to use birth control or remain abstinent.
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My biopsy after treatment failure shows non-squamous cell type.
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I am able to get out of my bed or chair and move around.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
6-month PFS rate
Duration of Response (DOR)
Incidence of Treatment-Related Adverse Events
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Tiragolumab plus atezolizumab and bevacizumabExperimental Treatment3 Interventions
Tiragolumab 600mg IV will be administered together with atezolizumab 1200mg IV and bevacizumab 15mg/kg IV every 3 weeks (q3w) until progressive disease or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tiragolumab
2020
Completed Phase 2
~350
Atezolizumab
2017
Completed Phase 3
~5860
Bevacizumab
2013
Completed Phase 4
~5280
Find a Location
Who is running the clinical trial?
Georgetown UniversityLead Sponsor
343 Previous Clinical Trials
136,460 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,540 Previous Clinical Trials
567,857 Total Patients Enrolled
Joshua Reuss, MDPrincipal InvestigatorGeorgetown University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My high blood pressure is not well controlled.I do not have any health issues that prevent me from taking experimental medications.I stopped immunotherapy permanently due to severe side effects.I have had cancer within the last 5 years.My condition worsened despite treatment targeting EGFR.I have not had a severe infection in the last 3 weeks.You have a high amount of protein in your urine, as shown by a urine test.I am 18 years old or older.I have previously received anti-TIGIT antibody therapy.My condition worsened despite treatment with anti-PD(L)1 therapy.You have a disease that can be measured using specific guidelines.My cancer has a specific EGFR mutation.Your tumor has a certain level of PD-L1 expression.I haven't taken any immune-weakening drugs in the last 2 weeks.I have a serious wound, ulcer, or untreated bone fracture that is not healing.My cancer does not have mutations in EGFR, ALK, or ROS1 genes.I have had cancer spread to the lining of my brain and spinal cord.I have a history of serious heart or blood vessel problems.My advanced lung cancer cannot be treated with surgery or radiation.I have a history of gastrointestinal issues.I have a history of serious bleeding or blood clotting issues.I have had lung conditions or infections before.I have received anti-PD(L)1 therapy for advanced NSCLC.I have had a previous transplant of stem cells or an organ.I have not had major surgery in the last 4 weeks.I agree to use birth control or remain abstinent.My blood and organ tests meet the required health standards.I have not received a live vaccine in the last 4 weeks.I have an autoimmune disease, but it's under control or not severe.My biopsy after treatment failure shows non-squamous cell type.I have brain metastases that are either untreated or causing symptoms.I am able to get out of my bed or chair and move around.I am currently taking or have recently taken specific medications.
Research Study Groups:
This trial has the following groups:- Group 1: Tiragolumab plus atezolizumab and bevacizumab
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.
What is Tiragolumab typically utilized to treat?
"Tiragolumab is a popular medication for treating non-small cell lung carcinoma, but it can also be beneficial in the treatment of postoperative and recurrent forms of NSCLC as well as platinum-sensitive epithelial ovarian cancer."
Answered by AI
What is the enrollment status for this clinical investigation?
"Affirmative. According to clinicaltrials.gov, this medical study is actively searching for enrolment; it was first published on December 21 2021 and the latest update occured April 25 2022. The trial seeks 42 individuals from one research site."
Answered by AI
How many participants are eligible to join this experiment?
"Affirmative. Data found on clinicaltrials.gov suggests that this medical study, initially posted on December 21st 2021, is actively looking for individuals to participate in the trial. A total of 42 participants are required at a single site."
Answered by AI
Have there been any previous investigations into the effects of Tiragolumab?
"At this moment in time, 621 studies on Tiragolumab are active. Of those, 142 have reached phase 3 trials and 31776 different sites are running clinical investigations of the medication. The majority of them can be found across Taibei, Taiwan."
Answered by AI
Has Tiragolumab been granted regulatory clearance from the FDA?
"Tiragolumab's safety is currently estimated at a 2 due to limited data regarding efficacy, though there have been some studies that suggest it has safe usage."
Answered by AI
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