2023-506891-28-00招募中3 期
A Phase III, Randomised, Double blind, Placebo controlled, Multicentre, International Study of Durvalumab plus Domvanalimab (AB154) in Participants with Locally Advanced (Stage III), Unresectable Non small Cell Lung Cancer Whose Disease has not Progressed Following Definitive Platinum based Concurrent Chemoradiation Therapy (PACIFIC-8)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 79
- 主要终点
- Progression Free Survival (PFS) using Blinded Independent Central Review (BICR) assessment according to RECIST 1.1 with participants with PD-L1 TC>=50%. PFS will be evaluated every 00 weeks (±00 days) from randomisation through 00 weeks, and q00w (± 00 days) thereafter until RECIST 1.1 defined radiological progression, plus 1 or more follow-up scans.
研究概览
简要总结
To demonstrate superiority of durvalumab plus domvanalimab relative to durvalumab plus placebo in participants with locally advanced, unresectable NSCLC who have not progressed on prior platinum-basedcCRT, with PD-L1 TC ≥ 50%, progression free survival (PFS) assessed by Blinded Independent Central Review (BICR).
研究设计
- 分配方式
- Randomized
- 主要目的
- Post-Treatment Follow up
- 盲法
- Double (Subject, Analyst, Carer, Monitor, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Participant must be ≥ 18 years at the time of screening.
- •Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease.
- •Provision of a tumor tissue sample obtained prior to CRT.
- •Documented tumor PD-L1 status ≥ 1% by central lab
- •Documented EGFR and ALK wild-type status (local or central).
- •Patients must not have progressed following definitive, platinum-based, concurrent chemoradiotherapy
- •Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy.
- •Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapy should be administered by intensity modulated RT (preferred) or 3D-conforming technique.
- •WHO performance status of 0 or 1 at randomization
- •Adequate organ and marrow function
排除标准
- •History of another primary malignancy, except for: -Malignancies treated with curative intent and adequate follow-up with no known active disease and have not required active treatment within the past 3 years before the first dose of study intervention and of low potential risk of recurrence. -Adequately resected non melanoma skin cancer or lentigo maligna without evidence of disease. -Adequately treated carcinoma in situ, including Ta tumors without evidence of disease.
- •Mixed small cell and non-small cell lung cancer histology.
- •Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC.
- •Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT.
- •Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy (excluding alopecia).
- •Participants with ≥ grade 2 pneumonitis from prior chemoradiation therapy.
- •History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathic pneumonitis – regardless of time of onset prior to randomisation. Evidence of active non-CRT induced pneumonitis (≥ Grade 2), active pneumonia, active ILD, active or recently treated pleural effusion, or current pulmonary fibrosis.
- •Active or prior documented autoimmune or inflammatory disorders (with exceptions)
- •Active EBV infection, or known or suspected chronic active EBV infection at screening
- •Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
结局指标
主要结局
Progression Free Survival (PFS) using Blinded Independent Central Review (BICR) assessment according to RECIST 1.1 with participants with PD-L1 TC>=50%. PFS will be evaluated every 00 weeks (±00 days) from randomisation through 00 weeks, and q00w (± 00 days) thereafter until RECIST 1.1 defined radiological progression, plus 1 or more follow-up scans.
Progression Free Survival (PFS) using Blinded Independent Central Review (BICR) assessment according to RECIST 1.1 with participants with PD-L1 TC>=50%. PFS will be evaluated every 00 weeks (±00 days) from randomisation through 00 weeks, and q00w (± 00 days) thereafter until RECIST 1.1 defined radiological progression, plus 1 or more follow-up scans.
次要结局
- PFS in PD-L1 TC ≥ 1% by BICR. Comparison of durvalumab + domvanalimab to durvalumab + placebo in TC ≥ 1% or TC ≥ 50% in: 1. Overall Survival (OS) 2. PFS by investigator 3. PFS6, PFS12, PFS18, PFS24 4. OS at 24 months 5. ORR and DoR by BICR 6. PFS2, TTDM, TFST 7. PK and immunogenicity of durvalumab and domvanalimab 8. Time to First Confirmed Deterioration (TTFCD) in pulmonary symptoms measured by the NSCLC-SAQ.
研究者
AstraZeneca Clinical Study Information Center
Scientific
Astrazeneca AB
研究点 (79)
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