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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
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Patients With Previously Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer
 
Region Sponsors
California - Northern
Hoffmann-La Roche
 
Acronym KP IRB No.
1723781
 
Study Type Phase
Clinical Trial Phase II
 
Study Population Description
(Adult, Older Adult) Male and Female with histologically or cytologically documented Non-small Cell Lung Cancer (NSCLC)
 
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).
 
Detailed Description
 
Gender Age Limit
Male & Female 18 years & older
 
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
  • Please contact study team for additional exclusion criteria

 
Keywords and/or Specific Medical Conditions
  • Antineoplastic Agents
  • Lung Neoplasms
  • Antineoplastic Agents, Immunological
  • Molecular Mechanisms of Pharmacological Action
  • Atezolizumab
  • Neoplasms
  • BO42592
  • Neoplasms by Site
  • Bronchial Neoplasms
  • Nucleic Acid Synthesis Inhibitors
  • Carboplatin
  • Pembrolizumab
  • Carcinoma, Bronchogenic
  • Pemetrexed
  • Carcinoma, Non-Small-Cell Lung
  • Respiratory Tract Diseases
  • Enzyme Inhibitors
  • Respiratory Tract Neoplasms
  • Folic Acid Antagonists
  • Thoracic Neoplasms
  • Lung Diseases
  • Oncology (Adult)
 
KP Clinical Facility
  • Vallejo Medical Center
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Jennifer Marie Suga, MD
Contact Information:
- Oncology Clinical Trials KPNC
-Vallejo Medical Center


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