Atezolizumab + Tiragolumab for Lung Cancer (SKYSCRAPER-03 Trial)

Palo Alto (17 mi)

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.

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

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

My radiotherapy was 54-66 Gy using advanced techniques.

I am fully active or can carry out light work.

My cancer did not worsen during or after platinum-based chemo and radiation therapy.

I know my PD-L1 status.

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.

I have previously been treated with specific immune therapies.

My cancer has spread to distant parts of my body.

My advanced lung cancer worsened after my last major treatment.

I have no major side effects from previous cancer treatments.

I have had severe lung inflammation from previous cancer treatments.

I have had a previous transplant of stem cells or an organ.

I have an active Epstein-Barr virus infection.

I am not pregnant or breastfeeding.

I have a history of lung inflammation not caused by infections.

I am receiving a specific treatment sequence for advanced lung cancer.

Treatment Details

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Atezolizumab + TiragolumabExperimental Treatment2 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: DurvalumabActive Control1 Intervention

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

Atezolizumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tecentriq for: