Clinical trial NCT05663866: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-12-23
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants with Infusion-related Reactions (IRRs)
timeFrame: Cycle 1 Day 1
Secondary outcomes:
measure: Percentage of Participants with Adverse Events (AEs) of Infusion-related Reactions (IRRs) at Cycle 1 Day 1
timeFrame: Cycle 1 Day 1
measure: Percentage of Participants with Adverse Events (AEs) of IRR by Severity at Cycle 1 Day 1
timeFrame: Cycle 1 Day 1
measure: Percentage of Participants with Adverse Events (AEs) of IRRs up to End of the Cycle 3
timeFrame: Up to end of the Cycle 3 (Each Cycle 28 days)
measure: Percentage of Participants with Adverse Events (AEs) of IRRs by Severity up to End of the Cycle 3
timeFrame: Up to end of the Cycle 3 (Each Cycle 28 days)
measure: Percentage of Participants with IRRs
timeFrame: Up to 30 days after end of treatment (14 months)
measure: Percentage of Participants with IRR by Severity
timeFrame: Up to 30 days after end of treatment (14 months)
measure: Percentage of Participants with Other Adverse Events (AEs)
timeFrame: Up to 30 days after end of treatment (14 months)
measure: Duration of Infusion Time for Pre-amivantamab Infusion Medications, IV Amivantamab Infusion, and Post-amivantamab Infusion Medications on Cycle 1 Day 1
timeFrame: Cycle 1 Day 1
measure: Percentage of Participants Completing Amivantamab Infusion Within 4 Hours on Cycle 1 Day 1
timeFrame: Within 4 hours on Cycle 1 Day 1
measure: Overall Response Rate (ORR)
timeFrame: Up to 14 months
measure: Duration of Response (DOR)
timeFrame: Up to 14 months
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Compassionate Cancer Care
state: California
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Renton
country: United States
facility: UW Medicine Valley Medical Center
state: Washington
city: Brest
country: France
facility: CHU Brest
city: Lyon Cedex 8
country: France
facility: Centre Leon Berard
city: Paris
country: France
facility: Hopital Cochin
city: Paris
country: France
facility: Hopital Europeen Georges-Pompidou
city: Rouen
country: France
facility: CHU Rouen Hopital Charles Nicolle
city: Strasbourg CEDEX
country: France
facility: Nouvel Hopital Civil - CHU Strasbourg
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Jeollanam-do
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seongnam si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Barcelona
country: Spain
facility: Hosp. de La Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Barcelona
country: Spain
facility: Hosp. Univ. Quiron Dexeus
city: Cáceres
country: Spain
facility: Hosp. San Pedro de Alcantara
city: Jerez de la Frontera
country: Spain
facility: Hosp. de Jerez de La Frontera
city: L Hospitalet De Llobregat
country: Spain
facility: Inst. Cat. Doncologia-H Duran I Reynals
city: Madrid
country: Spain
facility: Hosp. Gral. Univ. Gregorio Maranon
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Malaga
country: Spain
facility: Hosp Virgen de La Victoria
city: Palma de Mallorca
country: Spain
facility: Hosp. Univ. Son Espases
city: Santiago de Compostela
country: Spain
facility: Hosp. Clinico Univ. de Santiago
city: Valencia
country: Spain
facility: Inst. Valenciano de Oncologia
city: Valencia
country: Spain
facility: Hosp. Gral. Univ. Valencia
city: Zaragoza
country: Spain
facility: Hosp. Clinico Univ. Lozano Blesa
city: ChangHua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan City
country: Taiwan
facility: Chi-Mei Medical Center, Liouying
city: Taipei City
country: Taiwan
facility: Taipei Medical University
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: