A Study of Tiragolumab in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Genentech, Inc.
Study ID
NCT03563716
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab at a fixed dose of 1200 mg will be administered first by IV infusion Q3W on Day 1 of each 21-day cycle.
  • Tiragolumab — DRUG
    Tiragolumab at a fixed dose of 600 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
  • Placebo — DRUG
    Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.

Study Details

This study will evaluate the safety and efficacy of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in chemotherapy-naive patients with locally advanced unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), excluding patients with a sensitizing EGFR mutation or ALK translocation.

Key Dates

Start date
Aug 10, 2018
Status verified
Apr 2026
Primary completion
Jun 30, 2019
Completion
Nov 14, 2025

Study Design

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

Arms

  • Placebo Comparator: Placebo + Atezolizumab
    Participants will receive atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle and placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
  • Experimental: Tiragolumab + Atezolizumab
    Participants will receive atezolizumab at a fixed dose of 1200 mg administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle and tiragolumab at a dose of 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: From baseline until a total of 80 progression-free survival (PFS) events have occurred (up to approximately 11 months) ]

Locations (11)

FacilityCityStateZIPSite coordinators
Arizona Oncology Associates, PC - HALTempeArizona85284-
SCRI Florida Cancer Specialists SouthFort MyersFlorida33901-
Florida Cancer Specialists - NORTH - SCRI - PPDSSt. PetersburgFlorida33705-
Illinois Cancer SpecialistsArlington HeightsIllinois60005-
Illinois Cancer CarePeoriaIllinois61615-
University of Kansas Medical CenterWestwoodKansas66205-
Karmanos Cancer InstituteDetroitMichigan48201-
Research Medical CenterKansas CityMissouri64132-
SCRI Tennessee OncologyNashvilleTennessee37203-
Virginia Cancer Specialists, PCFairfaxVirginia22031-
Northwest Cancer Specialists - VancouverVancouverWashington98684-

Find similar trials in Tempe, AZ

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Arizona Oncology Associates, PC - HAL· Tempe, AZSCRI Florida Cancer Specialists South· Fort Myers, FLFlorida Cancer Specialists - NORTH - SCRI - PPDS· St. Petersburg, FLIllinois Cancer Specialists· Arlington Heights, ILIllinois Cancer Care· Peoria, ILUniversity of Kansas Medical Center· Westwood, KS

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