臨床研究等提出・公開システム

P2/3 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF TIRAGOLUMAB IN COMBINATION WITH ATEZOLIZUMAB PLUS CHEMOTHERAPY VERSUS PEMBROLIZUMAB PLUS CHEMOTHERAPY IN PATIENTS WITH PREVIOUSLY UNTREAT ADVANCED NON SQUAMOUS NSCLC

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

Isabelle Rooney

F. Hoffmann-La Roche Ltd

1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku Tokyo

clinical-trials@chugai-pharm.co.jp

Clinical trials information

Chugai Pharmaceutical Co., Ltd.

1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku Tokyo

+81-120-189-706

clinical-trials@chugai-pharm.co.jp

Not Recruiting

Oct. 01, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- 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.

- 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

Both

NON SMALL CELL LUNG CANCER

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

Efficacy,
Observation, Inspection, RECIST v1.1

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

+81-48-722-1111

May. 24, 2022

Yes

Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

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