EUCTR2022-003048-28-PL进行中（未招募）1 期
A PHASE Ib/II, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE SAFETY, ACTIVITY, AND PHARMACOKINETICS OF DIVARASIB IN COMBINATION WITH OTHER ANTI-CANCER THERAPIES IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WITH A KRAS G12C MUTATIO
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- 性别
- All
入选标准
- •- Histologically or cytologically documented locally advanced unresectable or metastatic non-squamous 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 expression
- •- For Cohort A, PD-L1 tumor cell expression >= 1% is required to
- •be eligible
- •- For Cohort B, PD-L1 tumor cell expression is not required to be
- •- 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •- Known concomitant second oncogenic driver with available targeted treatment
- •- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- •- Prior treatment with a KRAS G12C inhibitor
- •- Known hypersensitivity to any of the components of divarasib or pembrolizumab; or known hypersensitivity to pemetrexed, carboplatin,
- •or cisplatin (Cohort B only)
- •- 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
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