進行中(不再收案) NCT05633667

新型治療組合用於肺癌患者的研究

非小細胞肺癌淋巴瘤Phase IIII 期III 期IV 期EGFRALKPD-L1

此平台臨床試驗的目標是測試新型治療組合在肺癌參與者中的療效。子研究-01將在既往未接受治療的轉移性(已擴散的癌症)非小細胞肺癌(NSCLC)參與者中,比較不同的新型組合對比標準治療。

適應症:Lung Cancer、Advanced or Metastatic Non-Small-Cell Lung Cancer、Resectable Non-Small-Cell Lung Cancer

收案條件

納入條件

  • All Substudies:
  • Histologically or cytologically documented non-small-cell lung cancer (NSCLC).
  • No known actionable genomic alterations for which targeted therapies are available.
  • Eastern cooperative oncology group (ECOG) performance status score of 0 or 1.
  • Measurable disease per response evaluation criteria in solid tumors.
  • Adequate hematologic and end-organ function.
  • Individuals of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception.
  • Substudy 01: All Experimental arms
  • Stage IV NSCLC.
  • For individuals with nonsquamous histology: Epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) alteration negative.
  • PD-L1 status by central confirmation.
  • No prior systemic treatment for metastatic NSCLC.
  • Substudy 02: All Experimental arms
  • Stage IV NSCLC.
  • In individuals with nonsquamous histology and actionable EGFR, ALK, or other known genomic alterations must have received treatment with at least 1 targeted therapy to the appropriate genomic alteration.
  • Substudy 03: All Experimental arms
  • Previously untreated individuals with resectable (Stage II, IIIA, IIIB (T\[3-4\]N2) NSCLC (per American Joint Committee on Cancer (AJCC) Edition 8).
  • Planned surgery must comprise of lobectomy, sleeve lobectomy, or bi-lobectomy.
  • PD-L1 status by central confirmation.
  • For individuals with nonsquamous histology: Epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) alteration negative.

排除條件

  • All Substudies:
  • Mixed small-cell lung cancer and NSCLC histology.
  • Active second malignancy.
  • Active autoimmune disease.
  • History of or current non-infectious pneumonitis/interstitial lung disease.
  • Active serious infection within 4 weeks prior to study treatment.
  • Substudy 01 and 02
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Received previous anticancer therapy within 4 weeks prior to enrollment.
  • Substudy 03: All Experimental arms
  • NSCLC previously treated with systemic therapy or radiotherapy.
  • Received prior treatment with any anti-PD-(L)-1 or other immune checkpoint inhibitors (CPIs).

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。