Tiragolumab + Atezolizumab for Non-Small Cell Lung Cancer
(SKYSCRAPER-01 Trial)

Recruiting in Palo Alto (17 mi)

+222 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Hoffmann-La Roche

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of the study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in participants with previously untreated locally advanced, unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. Eligible participants will be randomized in a 1:1 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab.

Eligibility Criteria

This trial is for adults with advanced non-small cell lung cancer (NSCLC) that has high PD-L1 expression, no prior treatments for metastatic NSCLC, and no EGFR mutations or ALK translocations. Participants should be in good physical condition (ECOG 0 or 1), have measurable disease, and proper organ function. Exclusions include a history of certain lung diseases, previous immune therapy treatments, active hepatitis B/C, HIV positive status, other cancers within the last 5 years except those with low risk.

Inclusion Criteria

I haven't had any systemic treatment for my advanced lung cancer.

I am fully active or can carry out light work.

My blood and organs are functioning well.

+4 more

Exclusion Criteria

I have brain metastases that are untreated or getting worse.

My cancer has a known EGFR mutation or ALK fusion.

I haven't taken any immune-boosting drugs in the last 4 weeks or 5 half-lives before starting the study.

+8 more

Participant Groups

The study tests the effectiveness and safety of combining Tiragolumab with Atezolizumab versus a placebo combined with Atezolizumab in untreated advanced NSCLC patients selected based on PD-L1 expression. Patients are randomly assigned to either treatment group in equal numbers.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Tiragolumab + AtezolizumabExperimental Treatment2 Interventions

Participants will receive atezolizumab followed by tiragolumab every 3 weeks (Q3W) on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity.

Group II: Placebo + AtezolizumabPlacebo Group2 Interventions

Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity.

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

🇺🇸 Approved in United States as Tecentriq for: