NCT03064854终止1 期
Phase Ib, Multicenter, Open Label Study of PDR001 in Combination With Platinum Doublet Chemotherapy and Other Immunooncology Agents in PD-L1 Unselected, Metastatic NSCLS Patients (ElevatION:NSCLC-101 Trial)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 111
- 试验地点
- 6
- 主要终点
- Dose Limiting Toxicities (DLTs) during the first 6 weeks of therapy
研究概览
简要总结
The primary purpose of this study is to establish the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of PDR001 when administered in combination with platinum-doublet chemotherapy and other immunooncology agent(s) in treatment naive patients with PD-L1 unselected, advanced NSCLC, and to estimate the preliminary anti-tumor activity in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has stage IIIB (and is not a candidate for definitive multimodality therapy) or has stage IV NSCLC or relapsed locally advanced or metastatic NSCLC as follows:
- •Group A, group B and group C only: Patients not previously treated with any systemic anti-cancer therapy (e.g. cytotoxic drugs, targeted therapy, monoclonal antibody therapy including immunotherapy (e.g. PD-1/PD-L1 inhibitors) or targeted therapies, either experimental or not), with exception of neo-adjuvant or adjuvant therapy as depicted in inclusion criterion
- •Group D only: Patients who have received only one prior systemic therapy treatment consisting of a PD-1 and/or PD-L1 inhibitor with or without a CTLA4 inhibitor for NSCLC, with exception of neo-adjuvant or adjuvant therapy as depicted in inclusion criterion
- •The last dose of prior immunotherapy must have been administered at least 6 weeks prior to the start of study treatment (cycle 1 day 1).
- •Histologically or cytologically confirmed diagnosis of NSCLC that is EGFR Wild-type, ALK-negative rearrangement and ROS1-negative rearrangement
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Patients with at least 1 measurable tumor lesion as assessed by Computed Tomography (CT) Scan or Magnetic Resonance Imaging (MRI) according to RECIST 1.
排除标准
- •Patient with a history of severe hypersensitivity reaction to the planned study treatment including gemcitabine, paclitaxel, cisplatin, carboplatin, pemetrexed or any known excipients of these drugs
- •History of severe hypersensitivity reactions to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction.
- •Patient has history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention).
- •History of leptomeningeal metastases
- •Active, known or suspected autoimmune disease or a documented history of autoimmune disease, including ulcerative colitis and Crohn's disease (Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll).
- •Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment
研究组 & 干预措施
Group E: non-squamous, pem/cis (or carbo)+PDR001+canakinumab
Experimental
干预措施: Cisplatin (Drug)
Group A: squamous, gem/cis+PDR001
Experimental
干预措施: PDR001 (Drug)
Group A: squamous, gem/cis+PDR001
Experimental
干预措施: Cisplatin (Drug)
Group A: squamous, gem/cis+PDR001
Experimental
干预措施: Gemcitabine (Drug)
Group B: non-squamous, pem/cis+PDR001
Experimental
干预措施: PDR001 (Drug)
Group B: non-squamous, pem/cis+PDR001
Experimental
干预措施: Cisplatin (Drug)
Group B: non-squamous, pem/cis+PDR001
Experimental
干预措施: Pemetrexed (Drug)
Group C: paclitaxel/carbo+PDR001
Experimental
干预措施: PDR001 (Drug)
Group C: paclitaxel/carbo+PDR001
Experimental
干预措施: Carboplatin (Drug)
Group C: paclitaxel/carbo+PDR001
Experimental
干预措施: Paclitaxel (Drug)
Group E: non-squamous, pem/cis (or carbo)+PDR001+canakinumab
Experimental
干预措施: PDR001 (Drug)
Group E: non-squamous, pem/cis (or carbo)+PDR001+canakinumab
Experimental
干预措施: Pemetrexed (Drug)
Group E: non-squamous, pem/cis (or carbo)+PDR001+canakinumab
Experimental
干预措施: Carboplatin (Drug)
Group E: non-squamous, pem/cis (or carbo)+PDR001+canakinumab
Experimental
干预措施: Canakinumab (Drug)
结局指标
主要结局
Dose Limiting Toxicities (DLTs) during the first 6 weeks of therapy
时间窗: 42 days
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 42 days
Overall response rate (ORR) per local investigator assessment for groups A, B and C
时间窗: From baseline up to approximately 28 months
ORR is defined as the proportion of patients with best overall response (BOR) of complete response (CR) or partial response (PR), as per RECIST 1.1 and local investigator assessment for groups A, B and C
次要结局
- Canakinumab ADA incidence during treatment(Pre-infusion on Day 1 of Cycle 1 and 4 of induction phase, pre-infusion on Day 1 of Cycle 6, 14 and 20 of maintenance phase, end of treatment and 30 and 150-day post-treatment)
- Disease Control Rate (DCR) per Investigator(Up to approximately 28 months)
- Duration of Response (DOR) per Investigator(From date of first documented response to the first documented progression or death due to any cause, whichever comes first, assessed up to approximately 28 months)
- Overall Response Rate (ORR) per local investigator assessment for group E(Up to approximately 28 months)
- Overall survival (OS)(from date of start of treatment to date of death due to any cause (assessed up to approximately 3.5 years))
- Progression Free Survival (PFS) per Investigator(From start of treatment to the date of the first documented progression or death due to any cause, whichever comes first, assessed up to approximately 28 months)
- Time to Response (TTR) per Investigator(From start of treatment to the date of the first documented reponse (CR or PR), assessed up to approximately 28 months)
- PDR001 Antidrug antibodies (ADA) prevalence at baseline(Baseline)
- Trough plasma Concentration (Ctrough) of chemotherapy(Pre-infusion on Day 1 of Cycle 1, 3 and 4 of induction phase; Cycle = 21 Days)
- Trough plasma Concentration (Ctrough) of canakinumab(Pre-infusion on Day 1 of Cycle 1, 3 and 4 of induction phase; Cycle = 21 Days)
- Canakinumab ADA prevalence at baseline(Baseline)
- Incidence of Adverse Events (AEs)(through study completion, up to approximately 3.5 years)
- Trough plasma Concentration (Ctrough) of PDR001(Pre-infusion on Day 1 of Cycle 1 to 4 of induction phase; pre-infusion on Day 1 of Cycle 1 to 4, 6, 8 and every 6 cycle afterwards of maintenance phase; Cycle = 21 Days)
- PDR001 ADA incidence during treatment(Pre-infusion on Day 1 of Cycle 1 to 4 of induction phase, pre-infusion on Day 1 of Cycle 1, 2, 3, 4, 6, 8 and every 6 cycle afterwards of maintenance phase, end of treatment and 30 and 150-day post-treatment)
研究者
研究点 (6)
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