A Study of Tiragolumab in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer

Part of paid clinical trials in Denver, Colorado.

Sponsor
Hoffmann-La Roche
Study ID
NCT04294810
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Atezolizumab 1200 milligrams (mg) administered by intravenous (IV) infusion Q3W on Day 1 of each 21-day cycle.
  • Tiragolumab — DRUG
    Tiragolumab 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
  • Matching Placebo — DRUG
    Matching Placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.

Study Details

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.

Key Dates

Start date
Mar 4, 2020
Status verified
Jan 2026
Primary completion
Dec 30, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
620 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tiragolumab + Atezolizumab
    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.
  • Placebo Comparator: Placebo + Atezolizumab
    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.

Primary Outcome Measure

Investigator-Assessed Progression-Free Survival (PFS) in the Primary Analysis Set [ Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months) ]

Locations (9)

FacilityCityStateZIPSite coordinators
Rocky Mountain Cancer Center - DenverDenverColorado80220-
Yale Cancer CenterNew HavenConnecticut06520-
SCRI Florida Cancer Specialists NorthSt. PetersburgFlorida33705-
SCRI Florida Cancer Specialists PANTallahasseeFlorida32308-
US oncology research at Minnesota OncologySaint PaulMinnesota55102-
SCRI Oncology PartnersNashvilleTennessee37203-
Virginia Cancer Specialists (Fairfax) - USORFairfaxVirginia22031-
Onc & Hem Assoc SW VirginiaSalemVirginia24153-
Northwest Cancer Specialists - VancouverVancouverWashington98684-

Related coverage on Hipa.ai

Find similar trials in Denver, CO

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Rocky Mountain Cancer Center - Denver· Denver, COYale Cancer Center· New Haven, CTSCRI Florida Cancer Specialists North· St. Petersburg, FLSCRI Florida Cancer Specialists PAN· Tallahassee, FLUS oncology research at Minnesota Oncology· Saint Paul, MNSCRI Oncology Partners· Nashville, TN

Related Studies