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Premedication to Reduce Amivantamab Associated Infusion Related Reactions

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Dexamethasone
Montelukast
Methotrexate
Amivantamab
Lazertinib
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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]) Exclusion Criteria: 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

Sites / Locations

  • Compassionate Cancer CareRecruiting
  • Virginia Cancer SpecialistsRecruiting
  • CHU BrestRecruiting
  • Hopital Europeen Georges-PompidouRecruiting
  • CHU Rouen - Hopital Charles NicolleRecruiting
  • Nouvel Hopital Civil - CHU StrasbourgRecruiting
  • Chungbuk National University HospitalRecruiting
  • National Cancer CenterRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Gachon University Gil Medical CenterRecruiting
  • Chonnam National University Hwasun HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Hosp. de La Santa Creu I Sant PauRecruiting
  • Hosp. San Pedro de AlcantaraRecruiting
  • Hosp. de Jerez de La FronteraRecruiting
  • Inst. Cat. Doncologia-H Duran I ReynalsRecruiting
  • Hosp. Univ. 12 de OctubreRecruiting
  • Hosp. Virgen de La VictoriaRecruiting
  • Hosp. Clinico Univ. de SantiagoRecruiting
  • Hosp. Gral. Univ. ValenciaRecruiting
  • Hosp. Clinico Univ. Lozano BlesaRecruiting
  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
  • Taichung Veterans General HospitalRecruiting
  • Chi-Mei Medical Center, LiouyingRecruiting
  • Taipei Medical UniversityRecruiting
  • National Taiwan University HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Background Anti-cancer Therapy with Amivantamab Plus Lazertinib

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage of Participants with Infusion-related Reactions (IRRs)
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

Percentage of Participants with Adverse Events (AEs) of Infusion-related Reactions (IRRs) at 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
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
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
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
Percentage of participants with IRRs will be reported.
Percentage of Participants with IRR by Severity
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 Other Adverse Events (AEs)
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
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
Percentage of participants completing amivantamab infusion within 4 hours on Cycle 1 Day 1 will be reported.
Overall Response Rate (ORR)
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)
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.

Full Information

First Posted
December 16, 2022
Last Updated
October 9, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05663866
Brief Title
Premedication to Reduce Amivantamab Associated Infusion Related Reactions
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2023 (Actual)
Primary Completion Date
December 15, 2024 (Anticipated)
Study Completion Date
December 16, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Background Anti-cancer Therapy with Amivantamab Plus Lazertinib
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Montelukast
Intervention Description
Montelukast will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Methotrexate will be administered subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Amivantamab
Other Intervention Name(s)
JNJ-61186372
Intervention Description
Amivantamab will be administered intravenously.
Intervention Type
Drug
Intervention Name(s)
Lazertinib
Other Intervention Name(s)
JNJ-73841937
Intervention Description
Lazertinib tablets will be administered orally.
Primary Outcome Measure Information:
Title
Percentage of Participants with Infusion-related Reactions (IRRs)
Description
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.
Time Frame
Cycle 1 Day 1
Secondary Outcome Measure Information:
Title
Percentage of Participants with Adverse Events (AEs) of Infusion-related Reactions (IRRs) at Cycle 1 Day 1
Description
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.
Time Frame
Cycle 1 Day 1
Title
Percentage of Participants with Adverse Events (AEs) of IRR by Severity at Cycle 1 Day 1
Description
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.
Time Frame
Cycle 1 Day 1
Title
Percentage of Participants with Adverse Events (AEs) of IRRs up to End of the Cycle 3
Description
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.
Time Frame
Up to end of the Cycle 3 (Each Cycle 28 days)
Title
Percentage of Participants with Adverse Events (AEs) of IRRs by Severity up to End of the Cycle 3
Description
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.
Time Frame
Up to end of the Cycle 3 (Each Cycle 28 days)
Title
Percentage of Participants with IRRs
Description
Percentage of participants with IRRs will be reported.
Time Frame
Up to 30 days after end of treatment (14 months)
Title
Percentage of Participants with IRR by Severity
Description
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.
Time Frame
Up to 30 days after end of treatment (14 months)
Title
Percentage of Participants with Other Adverse Events (AEs)
Description
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.
Time Frame
Up to 30 days after end of treatment (14 months)
Title
Duration of Infusion Time for Pre-amivantamab Infusion Medications, IV Amivantamab Infusion, and Post-amivantamab Infusion Medications on Cycle 1 Day 1
Description
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.
Time Frame
Cycle 1 Day 1
Title
Percentage of Participants Completing Amivantamab Infusion Within 4 Hours on Cycle 1 Day 1
Description
Percentage of participants completing amivantamab infusion within 4 hours on Cycle 1 Day 1 will be reported.
Time Frame
Within 4 hours on Cycle 1 Day 1
Title
Overall Response Rate (ORR)
Description
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.
Time Frame
Up to 14 months
Title
Duration of Response (DOR)
Description
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.
Time Frame
Up to 14 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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]) Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Compassionate Cancer Care
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Cancer Specialists
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Name
CHU Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Europeen Georges-Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Rouen - Hopital Charles Nicolle
City
Rouen
ZIP/Postal Code
76000
Country
France
Individual Site Status
Recruiting
Facility Name
Nouvel Hopital Civil - CHU Strasbourg
City
Strasbourg CEDEX
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
ZIP/Postal Code
28644
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
National Cancer Center
City
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Bundang Hospital
City
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chonnam National University Hwasun Hospital
City
Jeollanam-do
ZIP/Postal Code
58128
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hosp. de La Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. San Pedro de Alcantara
City
Cáceres
ZIP/Postal Code
10003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. de Jerez de La Frontera
City
Jerez de la Frontera
ZIP/Postal Code
11407
Country
Spain
Individual Site Status
Recruiting
Facility Name
Inst. Cat. Doncologia-H Duran I Reynals
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Virgen de La Victoria
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinico Univ. de Santiago
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Gral. Univ. Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinico Univ. Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chi-Mei Medical Center, Liouying
City
Tainan City
ZIP/Postal Code
73657
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Medical University
City
Taipei City
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10043
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

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