Studieoverzicht
Study name: GDC-6036 + Pembrolizumab
Histology | NSCLC | ||
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Tumor stage | Stage III - IV | ||
Host / recruiting site 1 | Antoni van Leeuwenhoek | Enrollment | Closed |
Therapy line | First line (1L) | ||
Design |
OPEN-LABEL |
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Intervention | GDC-6036 (divarasib) 200mg or 400mg + Pembrolizumab |
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Key outcome parameters | To evaluate the safety and tolerability of GDC-6036 in combination with pembrolizumab |
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Key inclusion criteria | Measurable disease, as defined by RECIST v1.1 Adequate hematologic and end-organ function |
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Key exclusion criteria | Known concomitant second oncogenic driver with available targeted treatment Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases History of leptomeningeal disease Uncontrolled tumor-related pain Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once a month or more frequently) Uncontrolled or symptomatic hypercalcemia (e.g., ionized calcium >1.5 mmol/L, calcium >12 mg/dL, or corrected calcium greater than ULN) Significant cardiovascular disease within 3 months prior to initiation of study treatment Active or history of autoimmune disease or immune deficiency History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis |
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