NL-OMON53747招募中不适用
A PHASE Ib/II, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE SAFETY, ACTIVITY, AND PHARMACOKINETICS OF GDC-6036 IN COMBINATION WITH OTHER ANTI-CANCER THERAPIES IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WITH A KRAS G12C MUTATION - BO44426 - GDC-6036- NSCLC KRAS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Histologically or cytologically documented locally advanced unresectable or
- •metastatic NSCLC that is not eligible for curative surgery and/or definitive
- •chemoradiotherapy
- •- No prior systemic treatment for advanced unresectable or metastatic NSCLC
- •- Confirmation of Biomarker eligibility:
- •.. Documented history of the KRAS G12C mutation
- •.. Documented history of PD-L1 tumor cell expression >=1%
- •- Pre-treatment tumor tissue along with an associated pathology report is
- •required for all participants enrolled on study. Representative tumor
- •specimens must be in formalin*fixed, paraffin embedded (FFPE) blocks
- •(preferred) or 15 unstained, freshly cut, serial slides. Although 15 slides
- •are required, if only 10 slides are available, the participant may be eligible
- •for the study following consultation with the Sponsor
- •- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- •- Measurable disease, as defined by Response Evaluation Criteria in Solid
- •Tumors (RECIST) v1.1
排除标准
- •- Known concomitant second oncogenic driver with available targeted treatment
- •- Symptomatic, untreated, or actively progressing central nervous system (CNS)
- •- Prior treatment with a KRAS G12C inhibitor
- •- Known hypersensitivity to any of the components of GDC-6036 or pembrolizumab
- •- History of malignancy other than NSCLC within 5 years prior to initiation of
- •study treatment, with the exception of malignancies with a negligible risk of
- •metastasis or death (e.g., 5-year OS rate more >90%), such as adequately
- •treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized
- •prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer
- •- Uncontrolled tumor related pain, pleural effusion, pericardial effusion, or
- •ascites requiring recurrent drainage procedures, uncontrolled or symptomatic
- •hypercalcemia
- •- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g.,
- •bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis,
- •or evidence of active pneumonitis, active tuberculosis, significant
- •cardiovascular disease within 3 months prior to initiation of study treatment
研究者
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