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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.
Must not have
Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study.
Prior systemic therapy for metastatic disease is not allowed.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.
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I have not received systemic therapy for my metastatic disease.
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I have had a stem cell or organ transplant in the past.
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I have not received a live vaccine recently and do not plan to during or shortly after treatment.
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My cancer does not have genetic changes like EGFR, ALK, or ROS1.
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I haven't needed brain radiation or high-dose steroids for brain symptoms in the last 2 weeks.
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I do not have active tuberculosis.
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I have had cancer spread to the lining of my brain and spinal cord.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of Initiation of Salvage Radiation Therapy to Central Nervous System (CNS)
Secondary study objectives
Adverse Events Related to Treatment
Brain Metastasis Response Rate (BMRR)
Objective Response Rate (ORR)
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
Atezolizumab
2016
Completed Phase 3
~5860
Pemetrexed
2014
Completed Phase 3
~5550
Tiragolumab
2019
Completed Phase 3
~1390
Carboplatin
2014
Completed Phase 3
~6120

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor
1,560 Previous Clinical Trials
569,399 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

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05746481 — Phase 2
Lung Cancer Research Study Groups: Single Treatment Arm
Lung Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT05746481 — Phase 2
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05746481 — Phase 2
~14 spots leftby Sep 2025
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