2025-523599-21-00招募中2 期
A Master Protocol of a Phase II, Open-label, Multicenter, Global Platform Study to Evaluate the Safety and Efficacy of Immunotherapy With or Without Other Anticancer Drugs in Participants with Unresectable Stage III Non-small Cell Lung Cancer Planning to Undergo Concurrent Chemoradiotherapy (AQUARIUS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 11
- 试验地点
- 7
- 主要终点
- The safety and tolerability of immunotherapy with or without other anticancer drugs in participants with unresectable Stage III NSCLC will be assessed.
研究概览
简要总结
To assess the safety and tolerability of immunotherapy with or without other anticancer drugs in participants with unresectable Stage III NSCLC
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
- 否
入选标准
- •Histologically or cytologically documented squamous or non-squamous NSCLC.
- •Unresectable stage III NSCLC eligible for concurrent chemoradiation. (Stage should be determined based on IASLC v9.0 Staging Guidelines; resectability should be determined by a multidisciplinary evaluation.)
- •Documented absence of sensitizing EGFR (epidermal growth factor) mutations and ALK (anaplastic lymphoma kinase) rearrangements.
- •No known ROS1 or RET rearrangements detected as per local standard practice.
- •Eligible for definitive, platinum-based cCRT to a total radiation dose of 60 Gy in 30 fractions using photons.
- •ECOG performance status of 0 or
- •Known tumor PD-L1 "XXX" expression using documented local results with confirmed availablity of tumor tissue sample to confirm PD-L1 expression results.
- •At least one lesion that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline that 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 (preferred) or MRI, and is suitable for accurate repeated measurements.
- •Adequate organ and bone marrow function.
排除标准
- •Presence of small cell and/or neuroendocrine histology components; sarcomatoid variant; and/or other rare subtypes.
- •Tumor invasion of the great vessels (aorta, superior/inferior vena cava, and/or intrapericardial vessels).
- •Malignant pleural or pericardial effusion. Effusions must be assessed via thoracentesis or pericardiocentesis.
- •History of idiopathic pulmonary fibrosis, ILD, non-infectious/radiation ILD/pneumonitis that required steroids or any active signs of these conditions that cannot be ruled out by imaging at screening. Additional exclusions include organizing pneumonia or drug-induced pneumonitis/ILD.
- •History of organ transplant or allogeneic stem cell transplant.
- •History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years prior to treatment assigment and of low potential risk for recurrence. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease.
- •Active or prior documented autoimmune or inflammatory disorders requiring chronic systemic treatment.
- •Any prior or current systemic or radiation therapy received for NSCLC, or prior radiation therapy for any malignancy that included any lung tissue in the prior radiation fields.
- •Prior exposure to an anti-PD-1, anti-PD-L1, or anti-TIGIT therapy, or any other anticancer therapy targeting immune regulatory receptors or mechanisms.
研究组 & 干预措施
Rilvegostomig
Test
干预措施: Rilvegostomig (Drug)
CARBOPLATIN
Auxiliary
干预措施: CARBOPLATIN (Drug)
PEMETREXED
Auxiliary
干预措施: PEMETREXED (Drug)
PACLITAXEL
Auxiliary
干预措施: PACLITAXEL (Drug)
INFLIXIMAB
Auxiliary
干预措施: INFLIXIMAB (Drug)
MYCOPHENOLATE MOFETIL
Auxiliary
干预措施: MYCOPHENOLATE MOFETIL (Drug)
CISPLATIN
Auxiliary
干预措施: CISPLATIN (Drug)
结局指标
主要结局
The safety and tolerability of immunotherapy with or without other anticancer drugs in participants with unresectable Stage III NSCLC will be assessed.
The safety and tolerability of immunotherapy with or without other anticancer drugs in participants with unresectable Stage III NSCLC will be assessed.
次要结局
- PFS is defined as time from the date of treatment assignment/randomization or Cycle 1 Day 1 (as applicable, depending on the design of the relevant substudy) until radiological progression per RECIST 1.1 or death due to any cause (in the absence of progression).
- ORR is defined as the proportion of participants who have a CR or PR, "XXX" per RECIST 1.1 for induction therapy or overall.
- Concentration of immunotherapy in serum.
- Presence of anti-drug antibodies (ADAs), positive or negative and titers
研究者
Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (7)
Loading locations...
相似试验
招募中
1 期
Combination Immunotherapy for the Treatment of Chemotherapy-refractory Metastatic MSS CRCNCT07281716Dan Feng24
招募中
2 期
A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients with Advanced Liver Cancers (Morpheus-Liver)2023-506611-17-00F. Hoffmann-La Roche AG29
招募中
2 期
A Seamless Phase II/III, Observer-blind, to Evaluate Immunogenicity and Safety of Chikungunya Virus Vaccine in Healthy Subjects 12-65Years of Age.Active Immunisation for Chikungunya Virus InfectionNCT07555392Bharat Biotech International Limited1,000
招募中
1 期
An Open-label, Multicenter Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetic/Pharmacodynamic (PK/PD) Characteristics of SR604 Injection in Patients With Hemophilia A/B and Congenital Factor VII DeficiencyHemophilia AFactor VII DeficiencyHemophilia BNCT07644832Shanghai RAAS Blood Products Co., Ltd.76
招募中
1 期
A Clinical Study of Cizutamig in Thyroid Eye DiseaseThyroid Eye Disease, TEDNCT07597200Candid Therapeutics38