Atezolizumab + Tiragolumab for Lung Cancer

(SKYSCRAPER-03 Trial)

Recruiting in Palo Alto (17 mi)

+317 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Hoffmann-La Roche

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy and safety of atezolizumab in combination with tiragolumab compared with durvalumab in participants with locally advanced, unresectable Stage III non-small cell lung cancer (NSCLC) who have received at least two cycles of concurrent platinum-based chemoradiotherapy (CRT) and have not had radiographic disease progression.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for adults with Stage III non-small cell lung cancer (NSCLC) who've had some chemo and radiation but no disease progression. They need to be in good health overall, not pregnant, willing to use contraception, and have a life expectancy of at least 12 weeks. People can't join if they've had certain previous treatments for NSCLC or other cancers, specific gene mutations in their cancer, unresolved side effects from past treatments, autoimmune diseases, or are on immunosuppressive drugs.

Inclusion Criteria

You are expected to live for at least 12 weeks.

My lung cancer is at an advanced stage and cannot be removed by surgery.

I will not donate sperm during and for 3 months after treatment.

Exclusion Criteria

I am taking medication that weakens my immune system.

I have been newly diagnosed with Stage III lung cancer that cannot be surgically removed.

My NSCLC has an EGFR mutation or ALK fusion.

Treatment Details

Interventions

• Atezolizumab (Checkpoint Inhibitor)
• Durvalumab (Checkpoint Inhibitor)
• Tiragolumab (Checkpoint Inhibitor)

Trial Overview The study tests the effectiveness and safety of combining two drugs: Atezolizumab and Tiragolumab versus Durvalumab alone. All participants previously received platinum-based chemoradiotherapy without their cancer getting worse. The goal is to see which combination works better after this initial treatment.

Participant Groups

Group I: Atezolizumab + Tiragolumab Experimental Treatment 2 Interventions

Participants will receive atezolizumab administered intravenously (IV) on Day 1 of each 28-day cycle followed by tiragolumab administered IV on Day 1 of each 28-day cycle for a maximum of 13 cycles.

Group II: Durvalumab Active Control 1 Intervention

Participants will receive durvalumab administered IV during each 28-day cycle for a maximum of 13 cycles.

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University