A Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Participants With Previously Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT04619797
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

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

Interventions

  • Tiragolumab — DRUG
    Tiragolumab at a fixed dose of 600 milligrams (mg), administered by intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
  • Atezolizumab — DRUG
    Atezolizumab at a fixed dose of 1200 mg, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
  • Pemetrexed — DRUG
    Pemetrexed 500 milligrams per square meter (mg/m\^2), administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
  • Carboplatin — DRUG
    Carboplatin at dose of area under the concentration-time curve (AUC) of 5, administered by IV infusion, Q3W on Day 1 of each 21-day cycle for 4 cycles.
  • Cisplatin — DRUG
    Cisplatin 75 mg/m\^2, administered by IV infusion, Q3W on Day 1 of each 21-day cycle for 4 cycles.
  • Tiragolumab Matching Placebo — DRUG
    Matching placebo, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
  • Pembrolizumab — DRUG
    Pembrolizumab at a fixed dose of 200 mg, administered by IV infusion, Q3W, on Day 1 of each 21-day cycle.

Study Details

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of tiragolumab in combination with atezolizumab plus pemetrexed and carboplatin/cisplatin (Arm A) compared with placebo in combination with pembrolizumab plus pemetrexed and carboplatin/cisplatin (Arm B) in participants with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC). Eligible participants will be randomized in a 1:1 ratio to receive one of the following treatment regimens during the induction phase: * Arm A: Tiragolumab plus atezolizumab plus pemetrexed and carboplatin or cisplatin * Arm B: Placebo plus pembrolizumab plus pemetrexed and carboplatin or cisplatin Following the induction phase, participants will continue maintenance therapy with either tiragolumab in combination with atezolizumab and pemetrexed (Arm A) or placebo in combination with pembrolizumab and pemetrexed (Arm B).

Key Dates

Start date
Dec 15, 2020
Status verified
May 2026
Primary completion
Apr 19, 2024
Completion
Nov 20, 2025

Study Design

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

Arms

  • Experimental: Tiragolumab+Atezolizumab+Pemetrexed+Carboplatin or Cisplatin
    Induction treatment with tiragolumab in combination with atezolizumab plus pemetrexed and cisplatin or carboplatin will be administered to participants on Day 1 of each 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with tiragolumab in combination with atezolizumab and pemetrexed on Day 1 of each 21-day cycle.
  • Placebo Comparator: Placebo+Pembrolizumab+Pemetrexed+Carboplatin or Cisplatin
    Induction treatment with placebo in combination with pembrolizumab plus pemetrexed and cisplatin or carboplatin will be administered to participants on Day 1 of each 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with placebo in combination with pembrolizumab and pemetrexed on Day 1 of each 21-day cycle.

Primary Outcome Measure

Progression-free Survival (PFS) as Determined by the Investigator [ Time Frame: From randomization to first occurrence of PD or death from any cause (up to approximately 40 months) ]

Locations (11)

FacilityCityStateZIPSite coordinators
UCLALos AngelesCalifornia90095-
PIH Health Whittier HospitalWhittierCalifornia90602-
SCRI Florida Cancer Specialists SouthFort MyersFlorida33901-
SCRI Florida Cancer Specialists NorthSt. PetersburgFlorida33705-
Advent Health OrlandoWinter ParkFlorida32789-
Northwest Georgia Oncology Centers PC - MariettaMariettaGeorgia30060-
Fort Wayne Medical Oncology and Hematology, IncFort WayneIndiana46804-
Baptist Health LexingtonLexingtonKentucky40503-
Tennessee Oncology ChattanoogaChattanoogaTennessee37403-
Sarah Cannon Research Institute / Tennessee OncologyNashvilleTennessee37203-
Inova Schar Cancer InstituteFairfaxVirginia22031-

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By research site
UCLA· Los Angeles, CAPIH Health Whittier Hospital· Whittier, CASCRI Florida Cancer Specialists South· Fort Myers, FLSCRI Florida Cancer Specialists North· St. Petersburg, FLAdvent Health Orlando· Winter Park, FLNorthwest Georgia Oncology Centers PC - Marietta· Marietta, GA

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