癌研連線CancerLink
招募中 NCT06452277

進一步了解Sevabertinib在患有人表皮生長因子受體2 （ HER2 ）突變的晚期非小細胞肺癌（ NSCLC ）參與者中的作用以及與標準治療相比的安全性

非小細胞肺癌前列腺癌膀胱癌／泌尿道上皮癌Phase IIIIII 期IV 期EGFRHER2

研究人員正在尋找一種更好的方法來治療具有稱為人表皮生長因子受體2 （ HER2 ）突變的特定基因變化的晚期非小細胞肺癌（ NSCLC ）患者。晚期NSCLC是指已經擴散到附近或身體其他部位，或目前的治療方法不太可能控制的肺癌。HER2是一種幫助細胞生長和分裂的蛋白質。有時，癌細胞具有受損的HER2基因。

適應症：Advanced Non-small Cell Lung Cancer, HER2 Mutation

收案條件

納入條件

  • Participant must be ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signing the informed consent.
  • Documented histologically or cytologically confirmed locally advanced non-squamous NSCLC, not suitable for definitive therapy or metastatic non-squamous NSCLC at screening (small cell or mixed histologies are excluded) (Stage III-IV NSCLC).
  • Documented activating HER2 mutation in the tyrosine kinase domain (TKD) assessed by tissue molecular test in a CLIA-certified (US sites) or an equally accredited (outside of the US) local laboratory. However, participants may be included at the discretion of the investigator if the laboratory performing the assay is not CLIA or similar certified but the laboratory is locally accredited.
  • No prior systemic therapy for locally advanced or metastatic disease. No prior treatment with a HER2 ex20ins-targeted therapy (e.g. poziotinib, trastuzumab deruxtecan). Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the start of screening.
  • Eligible to receive treatment with the selected platinum-based doublet-chemotherapy (i.e. cisplatin/pemetrexed or carboplatin/pemetrexed) and pembrolizumab in accordance with the SmPC/Product Information.

排除條件

  • Known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for five years since initiation of that therapy. Exception: the following cancer types are acceptable within five years if curatively treated or under surveillance:
  • a. in situ cancers of cervix, breast, or skin,
  • b. superficial bladder cancer (Ta, Tis and T1),
  • c. limited-stage prostate cancer,
  • d. basal or squamous cancers of the skin.
  • Tumors with targetable alterations with approved available therapy, with the exception of HER2 mutation in the TKD.
  • Inability to discontinue treatment with chronic systemic corticosteroids. Participants who require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study. Replacement therapy (e.g., physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is acceptable, provided that the dose is stable for \>4 weeks prior to planned start of study intervention.
  • Pre-existing peripheral neuropathy that is Grade ≥2 by CTCAE (v5.0).
  • History of severe hypersensitivity reaction to treatment with a monoclonal antibody.
  • Prior radiotherapy outside of the brain within 21 days before of planned start of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.

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。