Print

Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 - Histologically or cytologically documented locally advanced unresectable or metastatic non-squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy - No prior systemic treatment for metastatic non-squamous NSCLC - Known tumor programmed death-ligand 1 (PD-L1) status - Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) - Life expectancy >= 12 weeks - Adequate hematologic and end-organ function - Negative human immunodeficiency virus (HIV) test at screening - Serology test negative for active hepatitis B virus or active hepatitis C virus at screening.

Exclusion Criteria

  • Mutations in epidermal growth factor receptor (EGFR) gene or anaplastic lymphoma kinase (ALK) fusion oncogene - Pulmonary lymphoepithelioma-like carcinoma subtype of NSCLC - Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases - Active or history of autoimmune disease or immune deficiency - History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis - History of malignancy other than NSCLC within 5 years prior to randomization, with the exception of malignancies with a negligible risk of metastasis or death - Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety - Treatment with investigational therapy within 28 days prior to initiation of study treatment - Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated protein 4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies - Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment - Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment - Known allergy or hypersensitivity or other contraindication to any component of the chemotherapy regimen the participant may receive during the study - Women who are pregnant, or breastfeeding - Known targetable c-ROS oncogene 1 (ROS1) or BRAFV600E genomic aberration.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Tiragolumab
    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.
    Other names:
    • MTIG7192A
  • Drug: Atezolizumab
    Atezolizumab at a fixed dose of 1200 mg, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
    Other names:
    • Tecentriq
  • Drug: Pemetrexed
    Pemetrexed 500 milligrams per square meter (mg/m^2), administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
  • Drug: Carboplatin
    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.
  • Drug: Cisplatin
    Cisplatin 75 mg/m^2, administered by IV infusion, Q3W on Day 1 of each 21-day cycle for 4 cycles.
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.
  • Drug: Pemetrexed
    Pemetrexed 500 milligrams per square meter (mg/m^2), administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
  • Drug: Carboplatin
    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.
  • Drug: Cisplatin
    Cisplatin 75 mg/m^2, administered by IV infusion, Q3W on Day 1 of each 21-day cycle for 4 cycles.
  • Drug: Tiragolumab Matching Placebo
    Matching placebo, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
  • Drug: Pembrolizumab
    Pembrolizumab at a fixed dose of 200 mg, administered by IV infusion, Q3W, on Day 1 of each 21-day cycle.

Recruiting Locations

St. Bernard's Hospital, Inc. d/b/a St. Bernards Medical Center
Jonesboro, Arkansas 72401

University Of Arkansas
Little Rock, Arkansas 72205

Kaiser Permanente - Vallejo
Vallejo, California 94589

PIH Health Whittier Hospital; NC
Whittier, California 90602

Orlando Health Inc.
Orlando, Florida 32806

SCRI Florida Cancer Specialists North; Research Office North Region.
Saint Petersburg, Florida 33705

Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia 30060

Baptist Health Lexington
Lexington, Kentucky 40503

Boston Medical Center
Boston, Massachusetts 02118

Cancer Care Specialists; Division of Clinical Research
Reno, Nevada 89511

Ballad Health
Kingsport, Tennessee 37660

Thompson Cancer Survival Center
Knoxville, Tennessee 37916-2305

Inova Schar Cancer Institute; Inova Schar Cancer Institute Infusion Pharmacy
Fairfax, Virginia 22031

Bon Secours Mercy Health
Midlothian, Virginia 23114

More Details

NCT ID
NCT04619797
Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: BO42592 https://forpatients.roche.com/
888-662-6728 (U.S. Only)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.