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Monoclonal Antibodies
Carboplatin + Pemetrexed + Atezolizumab for Lung Cancer
Phase 2
Recruiting
Led By Liza C Villaruz, MD
Research Sponsored by Liza Villaruz, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status ≤ 1.
Patients must have normal organ and marrow function as defined below: Absolute neutrophil count ≥1,500/mcL, Platelets ≥100,000/mcL, Total bilirubin ≤ institutional upper limit of normal (ULN), AST(SGOT)/ALT(SGPT) ≤2.5 × institutional ULN, Creatinine Clearance (CrCl) ≥45 mL/min/1.73 m2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial tests a drug combo for treating lung cancer with brain metastases, to see if it's safe and effective.
Who is the study for?
This trial is for adults with non-squamous NSCLC and untreated brain metastases. Participants must have normal organ function, no recent severe infections or surgeries, and not be on systemic immunosuppressants. They should agree to contraception if of childbearing potential and can't join if they've had certain treatments for metastatic disease or have specific viral infections.Check my eligibility
What is being tested?
The study tests the combination of tiragolumab with carboplatin, pemetrexed, and atezolizumab in treating metastatic non-squamous NSCLC patients who also have asymptomatic brain metastases. It aims to assess safety and how well this combination works as a first-line treatment.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation in organs, infusion-related reactions, fatigue, blood disorders like low platelet count or neutrophil count which could increase infection risk, liver issues indicated by elevated bilirubin levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active and can carry on all my pre-disease activities without restriction.
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My blood counts and liver/kidney functions are within normal ranges.
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I do not have active hepatitis B or am not on treatment for it.
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My lung cancer is non-squamous and confirmed by lab tests.
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I agree to not have sex or will use a condom, and I won't donate sperm.
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I am 18 years old or older.
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
Rate of Initiation of Salvage Radiation Therapy to Central Nervous System (CNS)
Secondary outcome measures
Adverse Events Related to Treatment
Brain Metastasis Response Rate (BMRR)
Objective Response Rate (ORR)
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Single Treatment ArmExperimental Treatment4 Interventions
Tiragolumab in combination with atezolizumab, pemetrexed, and carboplatin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemetrexed
2014
Completed Phase 3
~5250
Atezolizumab
2017
Completed Phase 3
~5860
Tiragolumab
2020
Completed Phase 2
~350
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,108 Total Patients Enrolled
Liza Villaruz, MDLead Sponsor
3 Previous Clinical Trials
40 Total Patients Enrolled
Liza C Villaruz, MDPrincipal InvestigatorUPMC Hillman Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.I have had lung issues like fibrosis or pneumonia, but not from radiation.I don't have any health issues that would make it unsafe for me to take a new drug.I have not received systemic therapy for my metastatic disease.You have had allergic reactions to drugs similar to atezolizumab or other drugs used in this study.I have had a stem cell or organ transplant in the past.I have not received a live vaccine recently and do not plan to during or shortly after treatment.I have had radiation for cancer spread outside the brain with the goal of easing symptoms.I have not had any cancer other than NSCLC in the last 2 years, except for very low-risk types.My blood counts and liver/kidney functions are within normal ranges.I do not have active hepatitis B or am not on treatment for it.I had treatment for early-stage lung cancer over a year ago.My cancer does not have genetic changes like EGFR, ALK, or ROS1.I am fully active and can carry on all my pre-disease activities without restriction.I have a brain tumor larger than 5mm that hasn't been treated, or it's grown after whole brain radiotherapy.You are allergic to Chinese hamster ovary cell products or any ingredients in atezolizumab or tiragolumab.My lung cancer is non-squamous and confirmed by lab tests.I have an autoimmune disease or immune deficiency, with some exceptions.I haven't needed brain radiation or high-dose steroids for brain symptoms in the last 2 weeks.I do not have active tuberculosis.I haven't taken any immune-weakening drugs in the last 2 weeks, with some exceptions.Women who could become pregnant must have a negative pregnancy test within 14 days before starting the study treatment.I agree to not have sex or will use a condom, and I won't donate sperm.A sample of your tumor is needed for research on specific markers.I have had cancer spread to the lining of my brain and spinal cord.I have not had a severe infection in the last 2 weeks.I am 18 years old or older.You don't need to have measurable disease in areas outside the brain according to specific medical guidelines.You have had serious allergic reactions to certain types of medications in the past.My doctor expects me to live for at least 12 more weeks.You should not have hepatitis C. If you have tested positive for hepatitis C, an additional test will be done to confirm if you have the infection. If you do have the infection, you cannot participate in the study.I do not have HIV, or if I do, it's under control with treatment.I haven't had major heart problems or unstable heart conditions in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Single Treatment Arm
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.
How secure is the Single Treatment Arm protocol for individuals?
"Our team at Power gauged the safety of Single Treatment Arm to be a 2, taking into account that this Phase 2 trial has generated some data which vouches for its security but none affirming its efficacy."
Answered by AI
What is the enrollment status of this trial?
"According to the clinicaltrials.gov website, this particular medical research is no longer recruiting patients as of February 16th 2023. Nonetheless, there are still 2700 other studies that seek participants across the globe at present."
Answered by AI
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