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Clinical Trials List

Protocol Number61186372NSC2005
Active

2023-05-01 - 2026-06-30

Phase II

Recruiting7

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

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

  • Trial Applicant

    Johnson & Johnson

  • Sponsor

    Janssen Research & Development LLC

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 黃文聰 院長室
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator JIN-YUAN SHIH Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林聖皓 Division of Thoracic Medicine
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yuh-Min Chen Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jen-Yu Hung Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chao-Hua Chiu
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

NSCLC

Objectives

To separately assess the potential of dexamethasone, montelukast and methotrexate administration, prior to IV amivantamab infusion, to decrease the incidence and/or severity offirst dose IRRs.

Test Drug

N/A

Active Ingredient

amivantamab

Dosage Form

Dosage

N/A

Endpoints

Rate of IRRs occurring on Cycle 1
Day 1 following administration of
oral lazertinib and IV amivantamab
combination therapy, which is
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.

Inclution Criteria

Age
1. Be ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is
taking place) at the time of informed consent.
Type of Participant and Disease Characteristics

2. Participant must have advanced or metastatic NSCLC
3. Progressed on or after prior treatment with osimertinib and platinum-based chemotherapy.
Prior use of first-or-second generation EGFR TKI is allowed if administered prior to
osimertinib.
4. Previously identified EGFR-mutated NSCLC (EGFR Exon19 deletion or L858R)
(identified locally in a Clinical Laboratory Improvement Amendments [CLIA]-certified
laboratory [or equivalent])
5. ECOG performance status grade of 0 or 1 (Attachment 1).
6. Participant must have organ and bone marrow function as follows:
a) Hemoglobin ≥9g/dL
b) ANC ≥1.5 x 109/L
c) Platelets ≥75 x 109/L
d) AST and ALT ≤3 x ULN
e) Total bilirubin ≤1.5 x ULN; participants with Gilbert’s syndrome can enroll if
conjugated bilirubin is within normal limits.
f) Have an estimated glomerular filtration rate (eGFR), based on the Modified Diet
in Renal Disease (MDRD)4-variable formula (see Attachment 5), of >30 mL/min.

Exclusion Criteria

Medical Conditions
1. Participant has uncontrolled inter-current illness, including but not limited to:
 Active infection (includes infection requiring treatment with antimicrobial therapy
[participants will be required to complete antibiotics 1 week prior to study
treatment] or diagnosed or suspected viral infection)
 Human immunodeficiency virus-positive participants are eligible if they meet
all of the following:
o No detectable viral load (ie, <50 copies/mL) at screening
o CD4+ count >300 cells/mm3 at screening
o No acquired immunodeficiency syndrome (AIDS)-defining opportunistic
infection within 6 months of screening.
 Receiving highly active antiretroviral therapy (HAART). Any changes in
HAART due to resistance/progression should occur at least 3 months prior to
screening. A change in HAART due to toxicity is allowed up to 4 weeks prior
to screening.
Note: HAART that could interfere with study treatment is excluded (consult
the sponsor for a review of medications prior to enrollment).Poorly controlled
(persistent) hypertension: systolic blood pressure >180 mm Hg; diastolic
blood pressure >100 mm Hg,
o Uncontrolled diabetes
o Active bleeding diathesis
o Impaired oxygenation requiring continuous oxygen supplementation
o Refractory nausea and vomiting
o Chronic gastrointestinal diseases, inability to swallow the formulated
product, or previous significant bowel resection that would preclude
adequate absorption of study treatment
o Any ophthalmologic condition that is either clinically unstable or requires
treatment
o Psychiatric illness/social situation that would limit compliance with study
requirements.
o Any condition for which, in the opinion of the investigator, participation
would not be in the best interest of the participant (eg, compromise the
well-being) or that could prevent, limit, or confound the
protocol-specified assessments

The Estimated Number of Participants

  • Taiwan

    25 participants

  • Global

    126 participants

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