2024-520101-39-00尚未招募3 期
A Phase III, Randomised, Open-Label, Multicentre Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung17)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 13
- 试验地点
- 9
- 主要终点
- To assess the superiority of Dato-DXd vs docetaxel by assessment of PFS by BICR according to RECIST v1.1 in participants with TROP2 QCS-NMR positive non-squamous NSCLC without AGA.
研究概览
简要总结
To assess the superiority of Dato-DXd relative to docetaxel by assessment of progression-free survival (PFS) by Blinded Independent Central Review (BICR) and overall survival (OS).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Pathologically documented Stage IIIB, IIIC, or Stage IV non-squamous NSCLC without AGA at the time of randomisation and meets the criteria for NSCLC: * Participants must have documented negative test results for EGFR, ALK, and ROS1 genomic alterations. * Has no known tumour genomic alterations in NTRK, BRAF, RET, MET exon 14 skipping, KRAS G12C, HER2 or any other actionable driver oncogenes for which there are locally approved and available targeted first-line therapies. * Prospectively assessed TROP2 QCS-NMR positive based on results from an appropriately validated investigational TROP2 RxDx device.
- •Documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.
- •Participants must have received platinum-based chemotherapy (PBC) in combination with anti-PD-1/anti-PD-L1 mAb as the only prior line of therapy or received PBC and anti-PD-1/anti-PD-L1 monoclonal antibody (in either order) sequentially as the only 2 prior lines of therapy.
- •Provision of acceptable FFPE tumour sample for assessment of TROP
- •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 ≥ 15mm) with CT or MRI and is suitable for accurate repeated measurements.
- •ECOG PS of 0 or
- •Adequate bone marrow reserve and organ function within 7 days before randomisation.
排除标准
- •Squamous, mixed NSCLC, or SCLC histology.
- •Has severe pulmonary function compromise per Investigator discretion.
- •NSCLC disease that is eligible for definitive local therapy alone.
- •History of another primary malignancy other than NSCLC, except for malignancy treated with curative intent with no known active disease within 3 years before randomisation and of low potential risk for recurrence.
- •Spinal cord compression or brain metastases, unless asymptomatic, stable, and not requiring treatment with corticosteroids or anticonvulsants for at least 7 days prior to randomisation.
- •Clinically significant corneal disease.
- •Has active or uncontrolled hepatitis B or C virus infection.
- •Known HIV infection that is not well controlled.
- •Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
- •History of non-infectious ILD/pneumonitis including radiation pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
结局指标
主要结局
To assess the superiority of Dato-DXd vs docetaxel by assessment of PFS by BICR according to RECIST v1.1 in participants with TROP2 QCS-NMR positive non-squamous NSCLC without AGA.
To assess the superiority of Dato-DXd vs docetaxel by assessment of PFS by BICR according to RECIST v1.1 in participants with TROP2 QCS-NMR positive non-squamous NSCLC without AGA.
To assess the superiority of Dato-DXd vs docetaxel by assessment of OS in participants with TROP2 QCS-NMR positive non-squamous NSCLC without AGA.
To assess the superiority of Dato-DXd vs docetaxel by assessment of OS in participants with TROP2 QCS-NMR positive non-squamous NSCLC without AGA.
次要结局
- Objective response rate (ORR)
- Duration of response (DoR)
- Time to second progression or death (PFS2)
- Characterise population PK and its relationship with efficacy and safety endpoints, and evaluate the effects of covariates on PK, efficacy, and safety
- Presence of antidrug antibody (ADAs) for Dato-DXd
- Time to deterioration (TTD) in pulmonary symptoms, physical functioning, and in GHS/QoL
- To assess TROP2 diagnostic test performance and relationship with other tumour-derived biomarkers or diagnostics tests, and support test development
- To assess the safety and tolerability of Dato-DXd vs docetaxel in participants with TROP2 QCS-NMR positive non-squamous NSCLC without AGA
研究者
Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (9)
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