C349 Bronchus or lung, unspecified Bronchus or lung, unspecified
Conditions
Interventions
None listed
Sponsors
F. HOFFMANN-LA ROCHE LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •?Signed Informed Consent Form •?Age ??18 years at time of signing Informed Consent Form •?Ability to comply with the study protocol, in the investigator´s judgment •?ECOG Performance Status of 0 or 1 •?Histologically or cytologically documented locally advanced or recurrent NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy, or metastatic Stage IV NSCLC •?No prior systemic treatment for metastatic NSCLC Patients who received prior neo-adjuvant, adjuvant chemotherapy, and/or chemoradiotherapy with curative intent for non-metastatic disease are eligible for the study if the therapy was completed at least 6 months prior to initiation of study treatment. •?Tumor PD-L1 expression with a TPS ??50%, as determined by the PD-L1 IHC 22C3 pharmDx assay and documented through central testing of a representative tumor tissue, in either a previously obtained archival tumor tissue or tissue obtained from a biopsy at screening Confirmed •?Measurable disease per RECIST v1.1 •?Life expectancy ??12 weeks •?Adequate hematologic and end-organ function, defined by the following laboratory test Results. •?For patients receiving therapeutic anticoagulation: stable anticoagulant regimen •?Negative HIV test at screening •?Negative hepatitis B surface antigen (HBsAg) test at screening See protocol for more detail.
Exclusion criteria
Exclusion criteria: •?NSCLC known to have a mutation in the EGFR gene or an ALK fusion oncogene are excluded from the study. •?Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases Spinal cord compression not definitively treated with surgery and/or radiation, and/or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ? 2 weeks prior to screening • History of leptomeningeal disease • Uncontrolled tumor-related pain • Patients requiring pain medication must be on a stable regimen at study entry. • Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Patients should be recovered from the effects of radiation. There is no required minimum recovery period. • Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrollment. • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once a month or more frequently). • Patients with indwelling catheters (e.g., PleurX®) are allowed regardless of drainage frequency. • Uncontrolled or symptomatic hypercalcemia (ionized calcium ? 1.5 mmol/L, calcium ? 12 mg/dL, or corrected calcium greater than ULN) • Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barre syndrome, or multiple sclerosis. • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. • History of radiation pneumonitis in the radiation field (fibrosis) is permitted. • Active tuberculosis • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease, or current alcohol abuse. • Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina. See protocol for more detail.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •?OS (overall survival) after randomization, defined as the time from randomization to death from any cause. NAME OF THE RESULT: •?OS (overall survival) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Throughout study.;•?PFS (progression-free survival) 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 NAME OF THE RESULT: •?PFS (progression-free survival) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Throughout study. | — |
Secondary
| Measure | Time frame |
|---|---|
| •?OS (overall survival) after randomization, defined as the time from randomization to death from any cause. NAME OF THE RESULT: •?OS (overall survival) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Throughout study.;•?PFS (progression-free survival) 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 NAME OF THE RESULT: •?PFS (progression-free survival) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Throughout study.;•?OS (overall survival) 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 NAME OF THE RESULT: •?OS (overall survival) rate PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Throughout study.;•?Confirmed ORR (objective response rate), 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 NAME OF THE RESULT: • ORR (objective response rate) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Throughout study.;•?DOR (duration of response) 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 NAME OF THE RESULT: • DOR (duration of response) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Throughout study.;•?PFS (progression-free survival) rate at 6 months and 12 months, defined as the propor | — |
Countries
Argentina, Australia, Austria, Brazil, Denmark, France, Germany, Greece, Hungary, Italy, Japan, Mexico, Peru, Spain, Switzerland, Taiwan, Turkey, United States
Outcome results
None listed