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Studieoverzicht

Study name: GDC-6036 + Pembrolizumab

Histology NSCLC
Tumor stage Stage IV
Host / recruiting sites Antoni van Leeuwenhoek
Enrollment Closed
Therapy line First line (1L)
Design

OPEN-LABEL
Intervention

GDC-6036 (divarasib) 200mg or 400mg + Pembrolizumab
Key outcome parameters

To evaluate the safety and tolerability of GDC-6036 in combination with pembrolizumab
Key inclusion criteria

Measurable disease, as defined by RECIST v1.1

Adequate hematologic and end-organ function
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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