^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    amivantamab SC (Ami-LC)

    i
    Other names: Ami-LC, Ami-HC, CNTO-4424, JNJ-611, JNJ-61186372, JNJ61186372
    Associations

    News

    Trials
    Company:
    J&J
    Drug class:
    EGFR inhibitor, c-MET inhibitor
    Related drugs:
    Associations

    News

    Trials
    14d
    Subcutaneous amivantamab vs intravenous amivantamab, both in combination with lazertinib, in refractory EGFR-mutated, advanced non-small cell lung cancer (NSCLC): Primary results, including overall survival (OS), from the global, phase 3, randomized controlled PALOMA-3 trial. (ASCO 2024)
    P3 | "Clinical Trial Registration Number: NCT05388669"
    Combination therapy • Late-breaking abstract • P3 data • Clinical
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    Leclaza (lazertinib) • amivantamab SC (Ami-LC)
    1m
    PALOMA: A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (clinicaltrials.gov)
    P1, N=166, Recruiting, Janssen Research & Development, LLC | Trial primary completion date: Jan 2024 --> Oct 2024
    Trial primary completion date • Metastases
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Leclaza (lazertinib) • amivantamab SC (Ami-LC)
    3ms
    PALOMA: A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (clinicaltrials.gov)
    P1, N=166, Recruiting, Janssen Research & Development, LLC | Trial completion date: Feb 2025 --> Oct 2025
    Trial completion date • Metastases
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Leclaza (lazertinib) • amivantamab SC (Ami-LC)
    4ms
    PALOMA: A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (clinicaltrials.gov)
    P1, N=166, Recruiting, Janssen Research & Development, LLC | N=116 --> 166
    Enrollment change • Metastases
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Leclaza (lazertinib) • amivantamab SC (Ami-LC)
    4ms
    PALOMA-3: A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=418, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Oct 2024 --> Jan 2025
    Trial completion date • Metastases
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
    |
    Tagrisso (osimertinib) • Leclaza (lazertinib) • amivantamab SC (Ami-LC)
    5ms
    PALOMA: A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (clinicaltrials.gov)
    P1, N=116, Recruiting, Janssen Research & Development, LLC | Active, not recruiting --> Recruiting | Phase classification: P1b --> P1 | Trial completion date: Oct 2024 --> Feb 2025
    Enrollment open • Phase classification • Trial completion date • Metastases
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Leclaza (lazertinib) • amivantamab SC (Ami-LC)
    5ms
    PALOMA-2: A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=390, Recruiting, Janssen Research & Development, LLC | Trial completion date: Nov 2025 --> Jul 2026
    Trial completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Tagrisso (osimertinib) • carboplatin • pemetrexed • Rybrevant (amivantamab-vmjw) • Leclaza (lazertinib) • amivantamab SC (Ami-LC)
    6ms
    PALOMA-2: A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=390, Recruiting, Janssen Research & Development, LLC | Trial completion date: Jan 2025 --> Nov 2025
    Trial completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Tagrisso (osimertinib) • carboplatin • pemetrexed • Rybrevant (amivantamab-vmjw) • Leclaza (lazertinib) • amivantamab SC (Ami-LC)
    6ms
    PALOMA: A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (clinicaltrials.gov)
    P1b, N=125, Active, not recruiting, Janssen Research & Development, LLC | Recruiting --> Active, not recruiting | Trial primary completion date: Oct 2023 --> Jan 2024
    Enrollment closed • Trial primary completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Leclaza (lazertinib) • amivantamab SC (Ami-LC)
    6ms
    A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=418, Active, not recruiting, Janssen Research & Development, LLC | Recruiting --> Active, not recruiting | Trial completion date: Feb 2024 --> Oct 2024
    Enrollment closed • Trial completion date • Metastases
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
    |
    Tagrisso (osimertinib) • Leclaza (lazertinib) • amivantamab SC (Ami-LC)
    7ms
    PALOMA: A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (clinicaltrials.gov)
    P1b, N=116, Recruiting, Janssen Research & Development, LLC | N=196 --> 116
    Enrollment change • Metastases
    |
    EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Leclaza (lazertinib) • amivantamab SC (Ami-LC)
    7ms
    A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=400, Recruiting, Janssen Research & Development, LLC | Trial primary completion date: Aug 2023 --> Nov 2023
    Trial primary completion date • Metastases
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
    |
    Tagrisso (osimertinib) • Leclaza (lazertinib) • amivantamab SC (Ami-LC)
    1year
    PALOMA: A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (clinicaltrials.gov)
    P1b, N=196, Recruiting, Janssen Research & Development, LLC | Trial primary completion date: Apr 2023 --> Oct 2023
    Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Leclaza (lazertinib) • amivantamab SC (Ami-LC)
    1year
    Subcutaneous amivantamab (ami) in patients (pts) with advanced solid malignancies: The PALOMA study—Updated safety and identification of the recommended phase 2 dose. (ASCO 2023)
    Ami SC was well tolerated with meaningful reductions in administration time and TEAEs. Ami SC provided a quantitative and qualitative improvement in the symptoms of IRRs vs historical IV rates. The identified RP2D for ami SC on the Q2W schedule achieved similar exposure as the approved IV dose.
    P2 data • Clinical • Metastases
    |
    EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    amivantamab SC (Ami-LC)
    1year
    PALOMA-2: A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=390, Recruiting, Janssen Research & Development, LLC | N=260 --> 390 | Trial completion date: May 2024 --> Nov 2024
    Enrollment change • Trial completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Tagrisso (osimertinib) • carboplatin • pemetrexed • Rybrevant (amivantamab-vmjw) • Leclaza (lazertinib) • amivantamab SC (Ami-LC)
    1year
    A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=400, Recruiting, Janssen Research & Development, LLC | Trial primary completion date: Jan 2024 --> Aug 2023
    Trial primary completion date • Metastases
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
    |
    Tagrisso (osimertinib) • Leclaza (lazertinib) • amivantamab SC (Ami-LC)
    over1year
    A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=400, Recruiting, Janssen Research & Development, LLC | Trial completion date: Aug 2024 --> Feb 2024
    Trial completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
    |
    Tagrisso (osimertinib) • Leclaza (lazertinib) • amivantamab SC (Ami-LC)
    over1year
    PALOMA-2: A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=260, Recruiting, Janssen Research & Development, LLC | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Tagrisso (osimertinib) • carboplatin • pemetrexed • Rybrevant (amivantamab-vmjw) • Leclaza (lazertinib) • amivantamab SC (Ami-LC)
    over1year
    A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=400, Recruiting, Janssen Research & Development, LLC | N=640 --> 400
    Enrollment change • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
    |
    Tagrisso (osimertinib) • Leclaza (lazertinib) • amivantamab SC (Ami-LC)
    over1year
    A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=640, Recruiting, Janssen Research & Development, LLC | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
    |
    Tagrisso (osimertinib) • Leclaza (lazertinib) • amivantamab SC (Ami-LC)
    over1year
    PALOMA-2: A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=260, Not yet recruiting, Janssen Research & Development, LLC | Trial completion date: May 2026 --> May 2024
    Trial completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Tagrisso (osimertinib) • carboplatin • pemetrexed • Rybrevant (amivantamab-vmjw) • Leclaza (lazertinib) • amivantamab SC (Ami-LC)
    over1year
    PALOMA-2: A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=260, Not yet recruiting, Janssen Research & Development, LLC | Trial completion date: May 2024 --> May 2026
    Trial completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Tagrisso (osimertinib) • carboplatin • pemetrexed • Rybrevant (amivantamab-vmjw) • Leclaza (lazertinib) • amivantamab SC (Ami-LC)
    over1year
    A Clinical Study of Lazertinib with Subcutaneous Amivantamab Administered via Manual Injection Compared with Intravenous Amivantamab or Amivantamab Subcutaneous On Body Delivery System in Patients with EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy Un estudio clínico de lazertinib con amivantamab subcutáneo administrado a través de una inyección manual en comparación con amivantamab intravenoso o sistema de administración corporal subcutáneo de amivantamab en pacientes con cáncer de pulmón de células no pequeñas avanzado o metastásico con mutación de EGFR después de la progresión con osimertinib y quimioterapia (clinicaltrialsregister.eu)
    P3, N=640, Ongoing, Janssen-Cilag International NV
    New P3 trial
    |
    EGFR (Epidermal growth factor receptor) • CD4 (CD4 Molecule)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR positive
    |
    Tagrisso (osimertinib) • Rybrevant (amivantamab-vmjw) • Leclaza (lazertinib) • amivantamab SC (Ami-LC)
    over1year
    PALOMA-2: A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2 | N=260 | Not yet recruiting | Sponsor: Janssen Research & Development, LLC
    New P2 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Tagrisso (osimertinib) • carboplatin • pemetrexed • Rybrevant (amivantamab-vmjw) • Leclaza (lazertinib) • amivantamab SC (Ami-LC)
    almost2years
    A Study of Lazertinib and Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=640, Not yet recruiting, Janssen Research & Development, LLC
    New P3 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
    |
    Tagrisso (osimertinib) • Rybrevant (amivantamab-vmjw) • Leclaza (lazertinib) • amivantamab SC (Ami-LC)
    over2years
    PALOMA: A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (clinicaltrials.gov)
    P1b, N=176, Recruiting, Janssen Research & Development, LLC | N=80 --> 176
    Enrollment change
    |
    EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Leclaza (lazertinib) • amivantamab SC (Ami-LC)
    3years
    [VIRTUAL] Subcutaneous delivery of amivantamab in patients with advanced solid malignancies: PALOMA, an open-label, multicenter, dose escalation phase 1b study. (ASCO 2021)
    To mitigate infusion related reactions (IRR), medication with steroid, paracetamol, and antihistamine will be given pre-infusion and as clinically indicated post-infusion . Blood samples will be collected to assess PK, pharmacodynamics, and immunogenicity . A Study Evaluation Team composed of investigators and sponsor representatives will review safety and PK data to make decisions about dose escalation and cohort expansion throughout the conduct of the study.
    P1 data • Clinical
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR mutation • MET amplification • MET mutation
    |
    Rybrevant (amivantamab-vmjw) • amivantamab SC (Ami-LC)
    over3years
    PALOMA: A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (clinicaltrials.gov)
    P1b, N=80, Recruiting, Janssen Research & Development, LLC | Not yet recruiting --> Recruiting
    Clinical • Enrollment open
    |
    EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    amivantamab SC (Ami-LC)
    over3years
    PALOMA: A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (clinicaltrials.gov)
    P1b, N=80, Not yet recruiting, Janssen Research & Development, LLC | Trial completion date: Sep 2024 --> Dec 2024
    Clinical • Trial completion date
    |
    EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    amivantamab SC (Ami-LC)
    over3years
    PALOMA: A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (clinicaltrials.gov)
    P1b, N=80, Not yet recruiting, Janssen Research & Development, LLC
    Clinical • New P1 trial
    |
    EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    amivantamab SC (Ami-LC)