A Phase IB, Open-Label, Multi-Center Study to Determine the Efficacy and Safety of Durvalumab and/or Novel Oncology Therapies, With or Without Chemotherapy, for First-Line Stage IV Non-Small Cell Lung Cancer (NSCLC) (MAGELLAN)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 175
- 试验地点
- 41
- 主要终点
- Assessment of AEs by CTCAE v5.0
研究概览
简要总结
This study is designed to determine the efficacy and safety of durvalumab and/or novel oncology therapies, with or without chemotherapy, for first-line Stage IV Non-Small Cell Lung Cancer (NSCLC)
详细描述
This is a Phase IB, Open-Label, Multi-Center Study to Determine the Efficacy and Safety of Durvalumab and/or Novel Oncology Therapies, With or Without Chemotherapy, for First-Line Stage IV Non-Small Cell Lung Cancer (NSCLC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically documented Stage IV NSCLC not amenable to curative surgery or radiation
- •No prior chemotherapy or any other systemic therapy for metastatic NSCLC
- •Prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for advanced disease are eligible, if progression has occurred >12 months from end of last therapy
- •Known tumor PD-L1 status
- •Tumors that lack activating EGFR mutations and ALK fusions or documented local test result for any other known genomic alteration for which a targeted therapy is approved in first line per local standard of care
- •WHO/ECOG status at 0 or 1 at enrollment
- •Life expectancy of at least 12 weeks
- •Troponin I or T ≤ ULN (per institutional guidelines)
排除标准
- •Active or prior documented autoimmune or inflammatory disorders
- •History of active primary immunodeficiency
- •Any prior chemotherapy or any other systemic therapy for metastatic NSCLC
- •Untreated CNS metastases
研究组 & 干预措施
B2
Durvalumab + Investigator's choice of chemotherapy + danvatirsen
干预措施: Carboplatin (Drug)
B4
MEDI5752
干预措施: MEDI5752 (Drug)
B3
Durvalumab + investigator's choice of chemotherapy + oleclumab
干预措施: Cisplatin (Drug)
A4
MEDI5752
干预措施: MEDI5752 (Drug)
B1
Durvalumab + Investigator's choice of chemotherapy
干预措施: Nab-paclitaxel (Drug)
B2
Durvalumab + Investigator's choice of chemotherapy + danvatirsen
干预措施: Nab-paclitaxel (Drug)
B3
Durvalumab + investigator's choice of chemotherapy + oleclumab
干预措施: Nab-paclitaxel (Drug)
A5
AZD2936
干预措施: AZD2936 (Drug)
B5
AZD2936 + chemotherapy
干预措施: AZD2936 (Drug)
B2
Durvalumab + Investigator's choice of chemotherapy + danvatirsen
干预措施: Cisplatin (Drug)
A1
Durvalumab
干预措施: Durvalumab (Drug)
A2
Durvalumab + danvatirsen
干预措施: Durvalumab (Drug)
A3
Durvalumab + oleclumab
干预措施: Durvalumab (Drug)
A2
Durvalumab + danvatirsen
干预措施: Danvatirsen (Drug)
B1
Durvalumab + Investigator's choice of chemotherapy
干预措施: Carboplatin (Drug)
B1
Durvalumab + Investigator's choice of chemotherapy
干预措施: Gemcitabine (Drug)
A3
Durvalumab + oleclumab
干预措施: Oleclumab (Drug)
B1
Durvalumab + Investigator's choice of chemotherapy
干预措施: Pemetrexed (Drug)
B1
Durvalumab + Investigator's choice of chemotherapy
干预措施: Durvalumab (Drug)
B1
Durvalumab + Investigator's choice of chemotherapy
干预措施: Cisplatin (Drug)
B2
Durvalumab + Investigator's choice of chemotherapy + danvatirsen
干预措施: Durvalumab (Drug)
B2
Durvalumab + Investigator's choice of chemotherapy + danvatirsen
干预措施: Pemetrexed (Drug)
B3
Durvalumab + investigator's choice of chemotherapy + oleclumab
干预措施: Durvalumab (Drug)
B2
Durvalumab + Investigator's choice of chemotherapy + danvatirsen
干预措施: Danvatirsen (Drug)
B2
Durvalumab + Investigator's choice of chemotherapy + danvatirsen
干预措施: Gemcitabine (Drug)
B3
Durvalumab + investigator's choice of chemotherapy + oleclumab
干预措施: Oleclumab (Drug)
B3
Durvalumab + investigator's choice of chemotherapy + oleclumab
干预措施: Carboplatin (Drug)
B3
Durvalumab + investigator's choice of chemotherapy + oleclumab
干预措施: Pemetrexed (Drug)
B3
Durvalumab + investigator's choice of chemotherapy + oleclumab
干预措施: Gemcitabine (Drug)
B5
AZD2936 + chemotherapy
干预措施: Pemetrexed (Drug)
B5
AZD2936 + chemotherapy
干预措施: Carboplatin (Drug)
B5
AZD2936 + chemotherapy
干预措施: Cisplatin (Drug)
结局指标
主要结局
Assessment of AEs by CTCAE v5.0
时间窗: From informed consent until the safety follow-up visit 3 months after the last dose of study drug, or until the final data cut-off (DCO) date, whichever is earlier.
Assessment of safety and tolerability of each treatment arm
次要结局
- Objective Response Rate (ORR)(Tumor assessments every 6-9 weeks until week 48-54, then every 12 or 18 weeks, depending on treatment arm until the earliest of radiological progression, death, withdrawal of consent, or final DCO (approximately 4 months after last patient randomized).)
- Duration of Response (DoR)(Tumor assessments every 6-9 weeks until week 48-54, then every 12 or 18 weeks, depending on treatment arm until the earliest of radiological progression, death, withdrawal of consent, or final DCO (approximately 4 months after last patient randomized).)
- Blood concentration of durvalumab and novel oncology therapies(From Cycle 1 Day 1 until Cycle 6/7 Day 1 (21-28-day cycles) depending on arm, then every 3 cycles (except for Arms A5 & B5), at end of treatment (Arms A4 & B4, A5 & B5 only), and until 3 months following treatment discontinuation, or the final DCO date.)
- Progression Free Survival (PFS)(Tumor assessments every 6-9 weeks until week 48-54, then every 12/18 weeks based on arm until progression, death, withdrawal or final DCO. Further PFS data will be collected until 6 months after last patient dosed or final DCO)
- Overall Survival (OS)(OS data will be collected until death, 6 months after last patient dosed, or the final DCO date, whichever is earlier.)
- Frequency of anti-drug antibodies (ADAs) for durvalumab and applicable novel oncology therapies(From Cycle 1 Day 1 until Cycle 6/7 Day 1 (21-28-day cycles) depending on arm, then every 3 or 6 cycles (except for arms A5&B5), at end of treatment (arms A4&B4, A5&B5 only), until 3/6 months after treatment discontinuation, or the final DCO date.)