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

JRCT ID: jRCT2031220087

Registered date:25/05/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: NON SMALL CELL LUNG CANCER
• Date of first enrollment: 07/11/2022
• Target sample size: 540
• Countries of recruitment: United States,Japan,Canada,Japan,Mexico,Japan,Brazil,Japan,Belgium,Japan,France,Japan,Germany,Japan,Italy,Japan,Spain,Japan,United Kingdom,Japan,Poland,Japan,Denmark,Japan,Kenya,Japan,Hong Kong,Japan,New Zealand,Japan,Thailand,Japan,South Korea,Japan,Taiwan,Japan,China,Japan
• Study type: Interventional

Intervention(s)

Tiragolumab: 600 mg administered by IV infusion every 3 weeks
Atezolizumab: 1200 mg administered by IV infusion every 3 weeks
Pemetrexed: 500 mg/m^2 administered by IV infusion every 3 weeks
Carboplatin: AUC 5mg/mL/min administered by IV infusion on Day 1 of each 21-day cycle for 4 cycles
Cisplatin: 75 mg/m^2 administered by IV infusion on Day 1 of each 21-day cycle for 4 cycles
Pembrolizumab: 200 mg administered by IV infusion every 3 weeks

Outcome(s)

Primary Outcome

Efficacy,
Observation, Inspection, RECIST v1.1

Secondary Outcome

Safety, Efficacy, Phamacokinetics
Observation, Inspection, RECIST v1.1

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

- ECOG PS of grade 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 RECIST v1.1
- Adequate hematologic and end-organ function
- Negative HIV test at screening
- Serology test negative for active hepatitis B virus or active hepatitis C virus at screening.

Exclude criteria

- Mutations in EGFR gene or 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
- Treatment with investigational therapy within 28 days prior to initiation of study treatment
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies
- Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer)
- Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment
- Known allergy or hypersensitivity to any component of the chemotherapy regimen
- Women who are pregnant, or breastfeeding
- Known targetable c-ROS oncogene 1 (ROS1) or BRAFV600E genomic aberration

Related Information

• Primary Sponsor: Isabelle Rooney
• Secondary ID(s): NCT04619797