本研究將評估 ceralasertib 與 durvalumab 聯合治療對比標準治療 docetaxel，用於既往接受抗 PD-(L)1 治療及鉑類化療後疾病惡化的局部晚期及轉移性 NSCLC 患者的療效及安全性。
適應症：Advanced or Metastatic Non-Small Cell Lung Cancer
收案條件
納入條件
- Histologically or cytologically documented NSCLC that is locally advanced or metastatic according to Version 8 of the IASLC Staging Manual in Thoracic Oncology.
- Documented epidermal growth receptor factor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type status as determined at a local laboratory.
- Documented radiological PD whilst on or after receiving the most recent treatment regimen.
- Eligible for second- or third-line therapy and must have received an anti-PD-(L)1 therapy and a platinum doublet containing therapy for locally advanced or metastatic NSCLC either separately or in combination.
- Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 0 or 1.
- Adequate organ function and marrow reserve
- Minimum life expectancy of 12 weeks.
- Body weight \> 30 kg and no cancer-associated cachexia.
- Negative pregnancy test (serum test) for women of childbearing potential (WOCBP).
排除條件
- Participant with mixed SCLC and NSCLC histology.
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention.
- Persistent toxicities (CTCAE Grade \> 2) caused by previous anticancer therapy.
- Active or prior documented autoimmune or inflammatory disorders.
- Participants who have received more than one line of prior anti-PD-(L)1, either alone or in any combination.
- Participants:
- Must not have experienced a toxicity that led to permanent discontinuation of the prior anti-PD(L)1 therapy.
- All AEs while receiving prior anti-PD(L)1 therapy must have completely resolved.
- Must not have experienced a Grade ≥ 3 immune-mediated adverse event (imAE) or an immune-related neurologic or ocular AE of any grade while receiving prior anti-PD(L)1 therapy.
- Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of \> 10 mg prednisone or equivalent per day.
- Participants who have received more than one prior line of platinum-based chemotherapy in metastatic setting.
- Participants who have received a prior ataxia telangiectasia and Rad3-related protein (ATR) inhibitor.
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。