A Study of Tiragolumab, an Anti-TIGIT Antibody, in Combination with Atezolizumab Compared with Placebo in Combination with Atezolizumab (an Anti-PD-L1 Antibody) in Patients with Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer.
- Conditions
- on-small cell lung cancer (NSCLC)MedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-002925-31-AT
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 560
- Age >= 18 years
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Histologically or cytologically documented locally advanced or recurrent NSCLC not eligible for curative surgery and/or definitive radiotherapy with or without chemotherapy, or metastatic Stage IV NSCLC
- No prior systemic treatment for metastatic NSCLC
- Tumor PD-L1 expression as determined by PD-L1 IHC assay TPS >= 50% as determined by 22C3 pharmaDx assay TC3 or IC3 as determined by the VENTANA PD-L1 Assay (SP142), or TC >= 50% as determined by the investigational VENTANA PD-L1 CDx Assay (SP263) of tumor tissue
- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
- Adequate hematologic and end-organ function
- For patients enrolled in the extended China enrollment phase: current resident of mainland China or Taiwan and of Chinese ancestry.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 284
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 276
- Known to have a mutation in the EGFR gene or an ALK fusion oncogene
- Symptomatic, untreated, or actively progressing central nervous system 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
- Significant cardiovascular disease
- History of malignancy other than NSCLC within 5 years, with the exception of malignancies with a negligible risk of metastasis or death treated with curative intent
- Severe infection within 4 weeks prior to initiation of study treatment
- Positive test result for human immunodeficiency virus (HIV)
- Active hepatitis B or hepatitis C infection- Treatment with investigational therapy within 28 days 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 prior to initiation of study treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method