招募中 NCT06667908

JNJ-90301900與放化療聯合治療非小細胞肺癌(NSCLC)的鞏固免疫療法研究

非小細胞肺癌Phase IIIII 期IV 期

本研究的目的是確定在局部晚期和不可切除的III期非小細胞肺癌參與者中, JNJ-90301900加入同時以鉑為基礎的雙聯化療加放射治療( cCRT ) ,再加上鞏固免疫治療( cIT )是否可以提高客觀反應率( ORR ;即研究期間最佳反應為完全反應或部分反應的參與者百分比)。

適應症:Carcinoma, Non-Small-Cell Lung

收案條件

納入條件

  • Must be a candidate for standard of care (SOC) treatment of non small cell lung cancer (NSCLC) by concurrent platinum-based doublet chemotherapy with radiation therapy (cCRT) followed by consolidation durvalumab treatment as determined by the investigator and per local guidelines at screening
  • Have a medical history of pathologically (histologically or cytologically) proven diagnosis of NSCLC within 3 months prior to enrollment/randomization
  • Have locally advanced unresectable stage III NSCLC according to the eighth edition lung cancer stage classification
  • Have at least 1 target lesion (primary lung lesion or involved lymph node\[s\]) per RECIST version 1.1 that is amenable to intratumoral and/or intranodal injection and intensity modulated radiation therapy (IMRT) as determined by the investigator at screening
  • Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

排除條件

  • Medical history of: (a) Primary immunodeficiency (b) Organ transplant that requires therapeutic immunosuppression
  • Any of the following within 3 months prior to enrollment/randomization: severe or unstable angina, myocardial infarction, clinically significant ventricular arrhythmias or heart failure New York heart association functional classification class III to IV
  • Another concurrent or prior primary malignancy within the last 36 months at informed consent
  • Known allergies, hypersensitivity, or intolerance to any ingredients of JNJ-90301900 crystalline solution, platinum-based doublet chemotherapy (ChT), or durvalumab
  • History of coagulation disorders, including: (a) Active bleeding diathesis or requirement for therapeutic anticoagulation or antiplatelet that cannot be interrupted or altered for JNJ-90301900 injection procedures, (b) Major thromboembolic events (for example, pulmonary embolism, cerebrovascular accident) within 3 months of enrollment or randomization

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。