Non-squamous non-small cell lung cancer Cancer
Conditions
Interventions
Participants will receive a single dose of tiragolumab, 600 mg, as an intravenous (IV) infusion, once every three weeks (Q3W) on Day 1 of each 21-day cycle. Participants will also receive a single-dos
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =18 years at time of signing Informed Consent Form 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 3. Histologically or cytologically documented locally advanced unresectable non-small cell lung cancer (NSCLC) (i.e., Stage IIIB not eligible for definitive chemoradiotherapy), recurrent, or metastatic NSCLC (i.e., Stage IV) (per the Union Internationale Contre le Cancer/American Joint Committee on Cancer [UICC/AJCC] staging system, 8th edition) of non-squamous histology 4. No prior systemic treatment for locally advanced unresectable or metastatic NSCLC 5. Tumour PD-L1 expression with a tumour cell (TC) =1%, as determined by the PD-L1 Immunohistochemistry (IHC) SP263 pharmDx assay performed by a central laboratory on previously obtained archival tumour tissue or tissue obtained from a biopsy at screening. 6. Confirmed availability of representative tumour specimens in formalin-fixed, paraffin embedded (FFPE) blocks (preferred) or at least 9 unstained serial slides, along with an associated pathology report. Measurable disease, as defined by RECIST v1.1 7. Life expectancy =12 weeks 8. Negative human immunodeficiency virus (HIV) test at screening 9. Negative hepatitis B surface antigen (HBsAg) test at screening 10. Negative hepatitis C virus (HCV) antibody test at screening
Exclusion criteria
Exclusion criteria: 1. Participants with non-squamous NSCLC known to have a sensitising mutation in the EGFR gene or an ALK fusion oncogene or ROS1 fusion oncogene 2. Participants with squamous NSCLC 3. Participants with the pulmonary lymphoepithelioma-like carcinoma subtype of NSCLC 4. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated protein (CTLA)-4, anti-PD-1, anti-PD-L1 and anti-T cell immunoreceptor with immunoglobulin and ITIM domain (TIGIT) therapeutic antibodies 5. Current treatment with anti-viral therapy for HBV or HCV 6. Treatment with investigational therapy within 28 days prior to initiation of study treatment 7. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases 8. Uncontrolled tumour-related pain 9. History of malignancy other than NSCLC within 5 years prior to initiation of study treatment, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate >90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localised prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer 10. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participants at high risk from treatment complications 11. Known allergy or hypersensitivity to any component of the study drugs or formulation 12. Prior allogeneic stem cell or solid organ transplantation 13. History of idiopathic pulmonary fibrosis, organising pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan 14. History of intra-abdominal inflammatory process within 6 months prior to initiation of study treatment, including but not limited to active peptic ulcer disease, diverticulitis, or colitis 15. Evidence of abdominal free air not explained by paracentesis or recent surgical procedure 16. Clear tumour infiltration into the thoracic great vessels is seen on imaging 17. Clear cavitation of pulmonary lesions is seen on imaging 18. Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation that such a live attenuated vaccine will be required during the study 19. Pregnant, lactating, or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR), as determined by the investigator according to Response Evaluation Criteria in Solid Tumours, version 1.1 (RECIST v1.1) from baseline up to confirmed disease progression, loss of clinical benefit, death, or loss of follow-up (up to approximately 4.5 years) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression-free survival (PFS), determined by the investigator using RECIST version 1.1 from initiation of study treatment up to confirmed disease progression, loss of clinical benefit, death, or loss of follow-up (up to approximately 4.5 years) 2. Overall survival (OS) measured from initiation of study treatment up to confirmed disease progression, loss of clinical benefit, death, or loss of follow-up (up to approximately 4.5 years) 3. Duration of response (DOR), determined by the investigator using RECIST version 1.1 from initiation of study treatment up to first occurrence of a documented objective response to confirmed disease progression, loss of clinical benefit, death, or loss of follow-up (up to approximately 4.5 years) 4. Number of participants with adverse events and serious adverse events, with severity determined per National Cancer Institute Common Terminology Criteria For Adverse Events, version 5.0 (NCI CTCAE v4.0) toxicity grade, from baseline up to follow-up visits (up to approximately 4.5 years) 5. Number of participants with cytokine release syndrome (CRS) and severity of CRS determined according to the American Society For Transplantation And Cellular Therapy (ASTCT) CRS consensus grading scale from day 1 up to follow-up visits (up to approximately 4.5 years) | — |
Countries
China
Contacts
Public ContactClinical Trials
Outcome results
None listed