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Checkpoint Inhibitor

Arm B: Atezolizumab and Tiragolumab for Non-Small Cell Lung Cancer

Phase 2

Recruiting

Led By Evanthia Galanis, MD

Research Sponsored by Alliance Foundation Trials, 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 2 years

Awards & highlights

Study Summary

This trial is testing the effectiveness of a combination treatment for a type of lung cancer that cannot be surgically removed. The treatment includes a drug called atezolizumab, with or without another

Who is the study for?

This trial is for adults with a new diagnosis of stage IIIA/B/C non-small cell lung cancer (NSCLC) who haven't had systemic therapy or radiation for their lung cancer. They should have normal organ function, no active autoimmune diseases, and be able to provide a tumor tissue sample. Patients unfit for surgery but fit for chemoradiotherapy can join.Check my eligibility

What is being tested?

The study tests the effectiveness of Atezolizumab immunotherapy alone or combined with Tiragolumab in addition to standard chemoradiotherapy. It's designed to see if adding Tiragolumab improves outcomes in unresectable stage III NSCLC patients.See study design

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs, infusion reactions similar to allergic responses, fatigue, potential liver and kidney function changes, and increased risk of infections due to immune system suppression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To determine the progression-free survival (PFS) of patients treated with neoadjuvant, concurrent and adjuvant atezolizumab with or without tiragolumab.

Secondary outcome measures

Overall survival (OS)

Safety of the two regimens

overall response (ORR)

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm C: Atezolizumab and TiragolumabExperimental Treatment2 Interventions

An additional pilot cohort of 20 patients will be accrued at selected sites towards the end of the overall accrual period and after initial safety evaluations of the addition of tiragolumab to atezolizumab before and after chemoradiotherapy. Participants enrolled to Arm C will receive induction immunotherapy with atezolizumab plus tiragolumab on Day 1 of each cycle, concurrent atezolizumab plus tiragolumab with chemoradiotherapy, and adjuvant atezolizumab plus tiragolumab on Day 1 of each 21 cycle.

Group II: Arm B: Atezolizumab and TiragolumabExperimental Treatment2 Interventions

79 participants will be randomized 1:1 to Arm B. Participants in Arm B will receive induction immunotherapy with atezolizumab plus tiragolumab on Day 1 of each cycle, concurrent atezolizumab with chemoradiotherapy, and adjuvant atezolizumab plus tiragolumab on Day 1 of each cycle.

Group III: Arm A: AtezolizumabExperimental Treatment1 Intervention

79 participants will be randomized 1:1 to Arm A. Participants in Arm A will receive induction immunotherapy with atezolizumab on Day 1 of each cycle, concurrent atezolizumab with chemoradiotherapy, and adjuvant atezolizumab Day 1 of each cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2017

Completed Phase 3

~5860

Tiragolumab

2020

Completed Phase 2

~350

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor

1,541 Previous Clinical Trials

567,965 Total Patients Enrolled

Alliance Foundation Trials, LLC.Lead Sponsor

23 Previous Clinical Trials

24,854 Total Patients Enrolled

Helen Ross, MDStudy ChairRush University

1 Previous Clinical Trials

64 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers actively seeking participants for this study at the moment?

"Indeed, the information available on clinicaltrials.gov indicates that this investigation is currently in the process of enrolling eligible individuals. The initial posting of this trial occurred on December 7th, 2023 and it was last modified on December 22nd, 2023. A total of three medical sites are involved in recruiting a target sample size of 178 patients for this study."

Answered by AI

What is the total number of participants being selected for enrollment in this clinical trial?

"Indeed, the information available on clinicaltrials.gov confirms that this trial is presently in the recruitment phase. The study was initially posted on December 7th, 2023 and underwent its most recent update on December 22nd, 2023. In order to complete the trial successfully, a total of 178 participants will be sought from three distinct locations."

Answered by AI

To what extent does Arm B, comprising the combination of Atezolizumab and Tiragolumab, pose a risk to individuals?

"Based on our evaluation, Arm B: Atezolizumab and Tiragolumab is given a safety score of 2 by our team at Power. This rating reflects the available data supporting its safety in this Phase 2 trial, although there is currently no evidence to support its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Atezolizumab Immunotherapy With or Without Tiragolumab for Patients With Unresectable Stage III NSCLC

2023. "Atezolizumab Immunotherapy With or Without Tiragolumab for Patients With Unresectable Stage III NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05798663.