Subcutaneous Methotrexate, Oral Dexamethasone or Oral Montelukast for the Prevention of Infusion Related Reaction Associated With Amivantamab, an EGFR-MET Bispecific Antibody, Among Post-osimertinib Treated EGFRm NSCLC; SKIPPirr, a Phase 2 Study
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 68
- 试验地点
- 68
- 主要终点
- Percentage of Participants With Infusion-related Reactions (IRRs) at Cycle 1 Day 1
研究概览
简要总结
The purpose of the study is to separately assess the potential of dexamethasone, montelukast and methotrexate administration, prior to amivantamab infusion given through a needle in the vein, to decrease the incidence and/or severity of first-dose infusion related reactions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Participant must have advanced or metastatic non-small cell lung cancer (NSCLC)
- •Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
- •A female participant using oral contraceptives must use an additional barrier contraceptive method
- •A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for 3 months after receiving the last dose of study treatment, oral lazertinib and intravenous (IV) Amivantamab
- •Each participant, or legally authorized representative, where allowed, must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
- •Progressed on or after prior treatment with osimertinib and platinum-based chemotherapy. Prior use of first-or-second generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) is allowed if administered prior to osimertinib
- •Previously identified EGFR-mutated non-small cell lung cancer (NSCLC) (EGFR Exon19 deletion or L858R) (identified locally in a Clinical Laboratory Improvement Amendments [CLIA]-certified laboratory [or equivalent])
排除标准
- •Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
- •Prior treatment with anti PD-1 or anti PD-L1 antibody within 6 weeks of planned first dose of study treatment or immune-mediated rash from checkpoint inhibitors that has not resolved prior to enrollment
- •Participant has symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study. Participants who have completed definitive therapy, are not on steroids, and have a stable clinical status for at least 2 weeks prior to study treatment are allowed. If brain metastases are diagnosed on Screening imaging, the participant may be enrolled, or rescreened for eligibility, after definitive treatment if above criteria are met
- •Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade 1 or baseline level (except for alopecia [any grade], Grade less than or equal to [<=] 2 peripheral neuropathy, and Grade <=2 hypothyroidism stable on hormone replacement therapy)
- •Prior treatment with amivantamab or lazertinib
研究组 & 干预措施
Background Anti-cancer Therapy with Amivantamab Plus Lazertinib
Participant will receive following treatments in 4 different cohorts prior to administration of combination therapy of IV Amivantamab and oral Lazertinib (anti-cancer regimen): dexamethasone dose-1 in Cohort A; dexamethasone dose-2 in Cohort A2; montelukast in Cohort B; and methotrexate in Cohort C.
干预措施: Montelukast (Drug)
Background Anti-cancer Therapy with Amivantamab Plus Lazertinib
Participant will receive following treatments in 4 different cohorts prior to administration of combination therapy of IV Amivantamab and oral Lazertinib (anti-cancer regimen): dexamethasone dose-1 in Cohort A; dexamethasone dose-2 in Cohort A2; montelukast in Cohort B; and methotrexate in Cohort C.
干预措施: Dexamethasone (Drug)
Background Anti-cancer Therapy with Amivantamab Plus Lazertinib
Participant will receive following treatments in 4 different cohorts prior to administration of combination therapy of IV Amivantamab and oral Lazertinib (anti-cancer regimen): dexamethasone dose-1 in Cohort A; dexamethasone dose-2 in Cohort A2; montelukast in Cohort B; and methotrexate in Cohort C.
干预措施: Amivantamab (Drug)
Background Anti-cancer Therapy with Amivantamab Plus Lazertinib
Participant will receive following treatments in 4 different cohorts prior to administration of combination therapy of IV Amivantamab and oral Lazertinib (anti-cancer regimen): dexamethasone dose-1 in Cohort A; dexamethasone dose-2 in Cohort A2; montelukast in Cohort B; and methotrexate in Cohort C.
干预措施: Methotrexate (Drug)
Background Anti-cancer Therapy with Amivantamab Plus Lazertinib
Participant will receive following treatments in 4 different cohorts prior to administration of combination therapy of IV Amivantamab and oral Lazertinib (anti-cancer regimen): dexamethasone dose-1 in Cohort A; dexamethasone dose-2 in Cohort A2; montelukast in Cohort B; and methotrexate in Cohort C.
干预措施: Lazertinib (Drug)
结局指标
主要结局
Percentage of Participants With Infusion-related Reactions (IRRs) at Cycle 1 Day 1
时间窗: Cycle 1 Day 1 (each cycle of 28 days)
Percentage of participants with IRRs at Cycle 1 Day 1 was reported. IRRs were defined as IRR events with onset time within 24 hours of the start of the first amivantamab infusion and prior to the start of amivantamab infusion on Cycle 1 Day 2. IRR included chills, dyspnea, flushing, nausea, chest discomfort, vomiting, tachycardia, hypotension, and fever. IRRs that occurred on Cycle 1 Day 2 pre-infusion were considered under Cycle 1 Day 1.
次要结局
- Percentage of Participants Completing Amivantamab Infusion Within 4 Hours on Cycle 1 Day 1(Up to 4 hours on Cycle 1 Day 1 (each cycle of 28 days))
- Overall Response Rate (ORR)(From Cycle 1 Day 1 (each cycle of 28 days) up to 28.3 months)
- Percentage of Participants With Adverse Events of Infusion-related Reactions (IRRs) During Cycle 1 Day 1(Cycle 1 Day 1 (each cycle of 28 days))
- Percentage of Participants With Adverse Events (AEs) of Infusion-related Reactions (IRRs) as Per Severity up to End of Cycle 3 (Cycle 3 Day 28)(From Cycle 1 Day 1 up to Cycle 3 Day 28 (each cycle of 28 days))
- Percentage of Participants With IRRs up to End of Treatment (EOT)(From Cycle 1 Day 1 (each cycle of 28 days) up to 27.3 months)
- Duration of Response (DOR)(From Cycle 1 Day 1 (each cycle of 28 days) up to 28.3 months)
- Percentage of Participants With Other Adverse Events (AEs): Non-IRRs(From Cycle 1 Day 1 (each cycle of 28 days) up to 28.3 months)
- Duration of Infusion Time for Pre-amivantamab Infusion Medications, IV Amivantamab Infusion, and Post-amivantamab Infusion Medications on Cycle 1 Day 1(Cycle 1 Day 1 (each cycle of 28 days))