Premedication to Reduce Amivantamab Associated Infusion Related Reactions
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Registration Number
- NCT05663866
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 73
- 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])
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Background Anti-cancer Therapy with Amivantamab Plus Lazertinib Montelukast 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. Background Anti-cancer Therapy with Amivantamab Plus Lazertinib Dexamethasone 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. Background Anti-cancer Therapy with Amivantamab Plus Lazertinib Methotrexate 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. Background Anti-cancer Therapy with Amivantamab Plus Lazertinib Amivantamab 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. Background Anti-cancer Therapy with Amivantamab Plus Lazertinib 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants with Infusion-related Reactions (IRRs) Cycle 1 Day 1 Percentage of participants with IRRs 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 will be reported.
- Secondary Outcome Measures
Name Time Method Percentage of Participants with IRR by Severity Up to 30 days after end of treatment (14 months) Percentage of participants with IRR by severity will be reported. Severity will be graded according to the NCI-CTCAE version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Percentage of Participants with Adverse Events (AEs) of Infusion-related Reactions (IRRs) at Cycle 1 Day 1 Cycle 1 Day 1 Percentage of participants with AEs of chills, dyspnea, flushing, nausea, chest discomfort, vomiting, tachycardia, hypotension, and fever will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical or biological agent under study.
Percentage of Participants with Adverse Events (AEs) of IRR by Severity at Cycle 1 Day 1 Cycle 1 Day 1 Percentage of participants with AEs of chills, dyspnea, flushing, nausea, chest discomfort, vomiting, tachycardia, hypotension, and fever by severity at Cycle 1 Day 1 will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical or biological agent under study. Severity will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Percentage of Participants with Adverse Events (AEs) of IRRs up to End of the Cycle 3 Up to end of the Cycle 3 (Each Cycle 28 days) Percentage of participants with AEs of chills, dyspnea, flushing, nausea, chest discomfort, vomiting, tachycardia, hypotension, and fever will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Percentage of Participants with Adverse Events (AEs) of IRRs by Severity up to End of the Cycle 3 Up to end of the Cycle 3 (Each Cycle 28 days) Percentage of participants with AEs of chills, dyspnea, flushing, nausea, chest discomfort, vomiting, tachycardia, hypotension, and fever by severity will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the NCI-CTCAE version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Percentage of Participants with IRRs Up to 30 days after end of treatment (14 months) Percentage of participants with IRRs will be reported.
Percentage of Participants with Other Adverse Events (AEs) Up to 30 days after end of treatment (14 months) Other AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study and which is not a serious adverse event.
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 Duration of infusion time for pre-amivantamab infusion medications, intravenous (IV) amivantamab infusion, and post-amivantamab infusion medications on Cycle 1 Day 1 will be reported.
Percentage of Participants Completing Amivantamab Infusion Within 4 Hours on Cycle 1 Day 1 Within 4 hours on Cycle 1 Day 1 Percentage of participants completing amivantamab infusion within 4 hours on Cycle 1 Day 1 will be reported.
Overall Response Rate (ORR) Up to 14 months ORR is defined as the percentage of participants who achieve either a complete (CR) or partial response (PR) as defined by investigator assessment using response criteria in solid tumors (RECIST) Version 1.1.
Duration of Response (DOR) Up to 14 months DOR is defined as time from initial response of CR or PR to progressive disease (PD) or death due to underlying disease, whichever comes first, only for participants who achieve CR or PR as defined by investigator assessment using response criteria in solid tumors (RECIST) Version 1.1.
Trial Locations
- Locations (36)
Hopital Europeen Georges-Pompidou
🇫🇷Paris, France
CHU Rouen Hopital Charles Nicolle
🇫🇷Rouen, France
Seoul National University Bundang Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Hosp. San Pedro de Alcantara
🇪🇸Cáceres, Spain
Hosp. de Jerez de La Frontera
🇪🇸Jerez de la Frontera, Spain
Centre Leon Berard
🇫🇷Lyon Cedex 8, France
UW Medicine Valley Medical Center
🇺🇸Renton, Washington, United States
Chungbuk National University Hospital
🇰🇷Cheongju-si, Korea, Republic of
Hosp. Clinico Univ. de Santiago
🇪🇸Santiago de Compostela, Spain
Hosp Virgen de La Victoria
🇪🇸Malaga, Spain
Inst. Cat. Doncologia-H Duran I Reynals
🇪🇸L Hospitalet De Llobregat, Spain
Hosp. Univ. 12 de Octubre
🇪🇸Madrid, Spain
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
National Cancer Center
🇰🇷Gyeonggi-do, Korea, Republic of
CHU Brest
🇫🇷Brest, France
Hopital Cochin
🇫🇷Paris, France
Nouvel Hopital Civil - CHU Strasbourg
🇫🇷Strasbourg CEDEX, France
Hosp. de La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Chonnam National University Hwasun Hospital
🇰🇷Jeollanam-do, Korea, Republic of
Hosp Univ Vall D Hebron
🇪🇸Barcelona, Spain
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Hosp. Univ. Quiron Dexeus
🇪🇸Barcelona, Spain
Hosp. Gral. Univ. Gregorio Maranon
🇪🇸Madrid, Spain
Hosp. Univ. Son Espases
🇪🇸Palma de Mallorca, Spain
Inst. Valenciano de Oncologia
🇪🇸Valencia, Spain
Changhua Christian Hospital
🇨🇳ChangHua, Taiwan
Hosp. Gral. Univ. Valencia
🇪🇸Valencia, Spain
Hosp. Clinico Univ. Lozano Blesa
🇪🇸Zaragoza, Spain
Chi-Mei Medical Center, Liouying
🇨🇳Tainan City, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Compassionate Cancer Care
🇺🇸Fountain Valley, California, United States
Virginia Cancer Specialists
🇺🇸Fairfax, Virginia, United States
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Kaohsiung Medical University Chung Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Taipei Medical University
🇨🇳Taipei City, Taiwan