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Checkpoint Inhibitor

Atezolizumab + Tiragolumab for Non-Small Cell Lung Cancer (SKYSCRAPER-15 Trial)

Phase 3

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group performance status of 0 or 1

Participants must have received between one to four cycles of adjuvant histology-based platinum doublet chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up year 3, year 5, year 7

Awards & highlights

SKYSCRAPER-15 Trial Summary

"This trial aims to see if adding tiragolumab to atezolizumab is more effective and safe than just using atezolizumab in patients with non-small cell lung cancer

Who is the study for?

This trial is for people who have had surgery to remove non-small cell lung cancer and completed chemotherapy. Participants should be in good health post-surgery with no evidence of the cancer returning.Check my eligibility

What is being tested?

The study tests if adding Tiragolumab to Atezolizumab (both are immunotherapy drugs) is better than using a placebo with Atezolizumab after lung cancer surgery and chemo.See study design

What are the potential side effects?

Possible side effects include immune-related reactions, such as inflammation in various organs, fatigue, infusion reactions similar to allergic responses, and potential increased risk of infections.

SKYSCRAPER-15 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I've had 1-4 rounds of specific chemotherapy for my cancer.

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My tumor shows PD-L1 expression of 1% or more.

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My lung cancer is at a specific advanced stage but not the most severe.

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I had surgery to completely remove my lung cancer.

SKYSCRAPER-15 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ year 3, year 5, year 7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~year 3, year 5, year 7

This trial's timeline: 3 weeks for screening, Varies for treatment, and year 3, year 5, year 7 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Disease-free Survival (DFS)

Secondary outcome measures

DFS Rate

Overall Survival (OS)

Percentage of Participants Who Maintained or Meaningfully Improved from Baseline in Patient-reported Role, Emotional, and Physical Functioning and Global Health Status (GHS)/Quality of Life (QoL)

+5 more

SKYSCRAPER-15 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Atezolizumab + TiragolumabExperimental Treatment2 Interventions

Participants will receive atezolizumab and tiragolumab intravenously (IV).

Group II: Atezolizumab + PlaceboPlacebo Group2 Interventions

Participants will receive atezolizumab and placebo IV.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2017

Completed Phase 3

~5860

Tiragolumab

2020

Completed Phase 2

~460

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,433 Previous Clinical Trials

1,089,418 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,202 Previous Clinical Trials

888,135 Total Patients Enrolled

Frequently Asked Questions

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

What is the current number of participants being enrolled in this clinical research study?

"To proceed with the research, we need a cohort of 1150 individuals who satisfy the trial's eligibility criteria. Hoffmann-La Roche is overseeing operations at various centers like Seoul National University Bundang Hospital in Seongnam-si and The Oncology Institute of Hope and Innovation; Cerritos located in Illinois and New mexico respectively."

Answered by AI

At how many distinct sites is this clinical trial being conducted?

"Among the options for participation in this study are Seoul National University Bundang Hospital located in Seongnam-si, The Oncology Institute of Hope and Innovation-Cerritos situated in Cerritos, and University of New mexico Cancer Center based in Albuquerque. Additionally, there are eleven alternative sites available for enrollment."

Answered by AI

Has the FDA officially authorized the combination of Atezolizumab and Tiragolumab for medical use?

"Power's assessment ranks the safety of Atezolizumab + Tiragolumab at 3 out of a possible scale range up to 3 due to its Phase 3 status, which signifies existing evidence backing effectiveness and robust safety data."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Tiragolumab Plus Atezolizumab Compared With Placebo Plus Atezolizumab in Participants With Completely Resected Non-small Cell Lung Cancer Who Have Received Adjuvant Platinum-based Chemotherapy

2024. "A Study of Tiragolumab Plus Atezolizumab Compared With Placebo Plus Atezolizumab in Participants With Completely Resected Non-small Cell Lung Cancer Who Have Received Adjuvant Platinum-based Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06267001.

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