lung cancer Small cell lung cancer
Conditions
Interventions
In the experimental arm, patients will receive atezolizumab at a fixed dose of
1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle, followed
by tiragolumab at a fixed dose of 600 m
Sponsors
Roche
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age > 18 years - Eastern Cooperative Oncology Group Performance Status of 0 or 1 - Histologically or cytologically documented locally advanced or recurrent 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.
Exclusion criteria
Exclusion criteria: - 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 prior to screening, with the exception of malignancies with a negligible risk of metastasis or death - Severe infection within 4 weeks prior to initiation of study treatment - Current treatment with anti-viral therapy for HBV or HCV - 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 or anticipation of need for systemic immunosuppressive medication during study treatment prior to initiation of study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -PFS after randomization, defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1, in the primary analysis set -OS after randomization, defined as the time from randomization to death from any cause, in the primary analysis set | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Investigator assessed PFS according to RECIST v1.1 in the secondary analysis set 2. Investigator assessed OS according to RECIST v1.1 in the secondary analysis set 3.Confirmed ORR, defined as the proportion of patients with a complete response (CR) or partial response (PR) on two consecutive occasions > 4 weeks apart, as determined by the investigator according to RECIST v1.1 4.DOR for patients with confirmed ORR, defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1 5.PFS rate at 6 months and 12 months, defined as the proportion of patients who have not experienced disease progression or death from any cause at 6 months and 12 months respectively, as determined by the investigator according to RECIST v1.1 6.OS rate at 12 months and 24 months, defined as the proportion of patients who have not experienced death from any cause at 12 and 24 months, respectively 7.Time to sustained deterioration (TTSD) in patient-reported physical functioning and global health status, as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Cancer (QLQ-C30) 8. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 9. Minimum serum concentration (Cmin) and Maximum serum concentrate (Cmax) of tiragolumab 10. Cmin and Cmax of atezolizumab 11. Prevalence of ADAs to tiragolumab and atezolizumab at baseline and during the study. | — |
Countries
Netherlands
Outcome results
None listed