2025-524843-11-00招募中2 期
A Master Protocol of an Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumour Activity of Novel Combinations in Participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (LIBRA)
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
- 70
- 试验地点
- 26
研究概览
简要总结
To assess the safety and tolerability and determine the recommended dose of the combination of novel anti-cancer agents To assess the efficacy of novel agents in combination with other anti-cancer agents by evaluation of ORR
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
- 否
入选标准
- •Participant must be ≥ 18 years of age at the time of signing the ICF
- •WHO/ECOG performance status of 0 or 1
- •At least 1 lesion that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline.
- •Adequate bone marrow and organ function
- •Life expectancy ≥ 12 weeks
- •Provision of acceptable tumour tissue
- •Specific for Sub-Study 1 and Sub-Study 2: Histologically or cytologically documented advanced or metastatic NSCLC
- •Specific for Sub-Study 1 and Sub-Study 2: PD-L1 TC ≥ 1% (TC≥ 50% for sub-study 1, 1-49% for sub-study 2)
- •Specific for Sub-Study 1 and Sub-Study 2: Absence of sensitizing EGFR mutations or ALK rearrangements. No known other Actionable Genomic Alterations(AGAs)
排除标准
- •As judged by the investigator, any severe or uncontrolled systemic diseases, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol
- •Prior exposure to immune-mediated therapy
- •History of uncontrolled hypertension, and active bleeding diseases, and high risks of bleeding and disorders of coagulation
- •Any concurrent anti-cancer treatment.
- •Receipt of live, attenuated vaccine within 30 days prior to the first dose of study intervention.
- •Active or prior documented autoimmune or inflammatory disorders
- •Persistent toxicities (CTCAE Grade ≥ 2) (NCI CTCAE v5.0) caused by previous anti cancer therapy, excluding alopecia.
- •Spinal cord compression or leptomeningeal carcinomatosis for sub-study 1 and sub-study
- •Unstable brain metastases
- •History of another primary malignancy.
- •Active infection, including TB and infections with HIV, HBV (verified by known positive HBsAg result), HCV.
- •Uncontrolled or significant cardiac disease
- •Receipt of prior systemic chemotherapy/chemoradiation/immunotherapy for advanced NSCLC for sub-study 1 and sub-study 2.
研究组 & 干预措施
Datopotamab deruxtecan
Test
干预措施: Datopotamab deruxtecan (Drug)
Rilvegostomig
Test
干预措施: Rilvegostomig (Drug)
RAMUCIRUMAB
Test
干预措施: RAMUCIRUMAB (Drug)
INFLIXIMAB
Auxiliary
干预措施: INFLIXIMAB (Drug)
MYCOPHENOLATE MOFETIL
Auxiliary
干预措施: MYCOPHENOLATE MOFETIL (Drug)
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (26)
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