A study to assess the effect of tiragolumab in presence of atezolizumab and bevacizumab in participants detected with lung cancer
- Conditions
- on-squamous non-small cell lung cancerCancer
- Registration Number
- ISRCTN10010669
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 43
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method