癌研連線CancerLink
招募中 NCT06793215

一項評估Divarasib和Pembrolizumab與Pembrolizumab和培美曲塞以及卡鉑或順鉑在既往未治療、KRAS G12C突變、晚期或轉移性非鱗狀非細胞肺癌參與者中的有效性和安全性的研究

非小細胞肺癌乳癌子宮頸癌／婦癌前列腺癌黑色素瘤Phase IIII 期III 期IV 期KRASPD-L1

本研究的目的是評估divarasib和pembrolizumab與pembrolizumab、培美曲塞和卡鉑或順鉑相比，對KRAS G12C突變、晚期或轉移性非鱗狀非小細胞肺癌(NSCLC)成人參與者的一線治療的有效性和安全性。

適應症：Non-Small Cell Lung Cancer、KRAS G12C Lung Cancer

收案條件

納入條件

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Histologically or cytologically confirmed diagnosis of advanced or metastatic non squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy
  • Measurable disease, as defined by RECIST v1.1
  • No prior systemic treatment for advanced or metastatic NSCLC
  • Documentation of the presence of a KRAS G12C mutation
  • Documentation of known PD-L1 expression status in tumor tissue
  • Availability of a representative tumor specimen
  • Adequate end-organ function
  • Eligible to receive a platinum-based chemotherapy regimen

排除條件

  • Known concomitant second oncogenic driver with available targeted treatment
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
  • Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for \>=2 weeks prior to randomization
  • 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)
  • Any anti-cancer systemic therapy, including hormonal therapy, within 21 days prior to randomization, or is expected to require any other form of antineoplastic therapy while in the study
  • Radiation therapy including palliative RT to bone metastases within 2 weeks prior to randomization and RT to the lung \>30Gy within 6 months prior to randomization
  • Prior treatment with KRAS G12C inhibitors or pan-KRAS/RAS inhibitors
  • Treatment with systemic immunosuppressive or immunostimulatory medications, including CD137 agonists and immune checkpoint inhibitors
  • Current treatment with medications that are well known to prolong the QT interval
  • Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to randomization
  • Prior allogeneic stem cell or solid organ transplantation
  • History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival \[OS\] rate \>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
  • Individuals with chronic diarrhea, short bowel syndrome or significant upper gastrointestinal surgery including gastric resection, a history of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) or any active bowel inflammation (including diverticulitis), malabsorption syndrome, conditions that would interfere with enteral absorption
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest computed tomography scan
  • Significant cardiovascular disease within 3 months prior to screening

收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。