癌研連線CancerLink
招募中 NCT06350097

一線Osimertinib ± Datopotamab Deruxtecan治療EGFRm局部晚期或轉移性非小細胞肺癌的III期開放標籤研究

非小細胞肺癌肉瘤Phase IIIIII 期IV 期EGFRMET

本研究的目的是評估osimertinib （片劑）與Dato-DXd （靜脈輸注）聯合治療與osimertinib （片劑）單一治療在局部晚期或轉移性EGFRm （ Ex19del和/或L858R ） NSCLC受試者中的一線治療的有效性和安全性。 研究詳情包括： 1.研究持續時間將由事件驅動，預計持續時間約為8年。 2.

適應症：Non-small Cell Lung Cancer

收案條件

納入條件

  • Participant must be ≥ 18 years.
  • Type of Participant and Disease Characteristics
  • Histologically or cytologically documented nonsquamous NSCLC. NSCLC of mixed histology is allowed if adenocarcinoma is the predominant histology. Mixed small-cell lung cancer and NSCLC histology, and sarcomatoid variant of NSCLC is ineligible.
  • Stage IIIB or IIIC or Stage IV metastatic NSCLC or recurrent NSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative surgery or definitive chemoradiation at the time of randomisation.
  • Participants must not have received prior EGFR TKIs or other systemic therapy for Stage IIIB, IIIC or IV NSCLC.
  • The tumour harbors at least 1 of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del or L858R), either alone or in combination with other genomic alterations, which may include EGFR T790M, assessed by a CLIA-certified (US sites) or an accredited (outside of the US) local laboratory or by central prospective tissue testing.
  • For participants enrolled in randomisation period, mandatory provision of an unstained, archival tumour tissue sample in a quantity sufficient to allow for central confirmation of the EGFR mutation status.
  • WHO performance status of 0 or 1.
  • At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short axis ≥15 mm) with CT or MRI and is suitable for accurate repeated measurements.
  • Adequate bone marrow reserve and organ function before the first dose of study intervention.

排除條件

  • As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, including active bleeding diseases, history of allogenic organ transplant which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol.
  • Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of osimertinib.
  • History of another primary malignancy.
  • Spinal cord compression and/or unstable brain metastases.
  • Clinically significant corneal disease.
  • Has active or uncontrolled hepatitis B or C virus infection, as defined by Protocol.
  • Past medical history of ILD/penumonitis, including radiation pneumonitis (apart from radiation pneumonitis that did not require steroids), or drug-induced ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
  • Has clinically severe pulmonary function compromise resulting from intercurrent pulmonary illnesses.

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。