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NCT05388669 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2026-08-31

The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

For All Regions Other Than the European Union (EU) and Others Accepting Cycle 2 Day 1: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State

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outcome · POSTED

For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab

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outcome · POSTED

Area Under the Concentration (AUC) Time Curve of Amivantamab From Day 1 to Day 15 (AUC [Day 1-15]) of Cycle 2

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outcome · NOT POSTED

Objective Response Rate (ORR)

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outcome · NOT POSTED

Progression-Free Survival (PFS)

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outcome · NOT POSTED

Duration of Response (DOR)

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outcome · NOT POSTED

Time to Response (TTR)

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outcome · NOT POSTED

Number of Participants With Adverse Events (AEs)

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outcome · NOT POSTED

Number of Participants With AEs by Severity

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outcome · NOT POSTED

Number of Participants With Clinical Laboratory Abnormalities

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outcome · NOT POSTED

Number of Participants With Clinical Laboratory Abnormalities by Severity

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outcome · NOT POSTED

Number of Participants With Infusion Related Reactions (IRRs)

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outcome · NOT POSTED

Number of Participants With IRRs by Severity

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outcome · NOT POSTED

For All Regions Other Than the EU and Others Accepting Cycle 2 Day 1: Observed Serum Concentration (Ctrough) of Amivantamab at Pre-dose on Cycle 2 Day 1

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outcome · NOT POSTED

For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State on Cycle 4 Day 1

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outcome · NOT POSTED

Model-Predicted Area Under the Concentration Time Curve of Amivantamab at Steady State From Day 1 to Day 15 (AUC [Day 1-15]) of Cycle 4

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outcome · NOT POSTED

Percentage of Participants With Presence of Anti-amivantamab Antibodies and Anti-rHuPH20 Antibodies

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outcome · NOT POSTED

Percentage of Participants With Cancer Therapy Satisfaction as Assessed by Therapy Administration Satisfaction Questionnaire (TASQ)

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outcome · NOT POSTED

Change From Baseline in Therapy Administration Satisfaction Questionnaire (TASQ) as Assessed Over Time

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outcome · NOT POSTED

Participant Chair Time

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outcome · NOT POSTED

Participant Chair Time in Treatment Room

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outcome · NOT POSTED

Duration of Treatment Administration

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outcome · NOT POSTED

Active Health Care Professional (HCP) Time For Drug Preparation, Treatment Administration and Post-treatment Monitoring

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Have histologically or cytologically confirmed, advanced or metastatic non-small cell lung cancer (NSCLC), characterized by either epidermal growth factor receptor (EGFR) Exon 19 deletion (Exon 19del) or Exon 21 leucine 858 to arginine substitution (Exon 21 L858R) mutation by an Food and Drug Administration (FDA)-approved or other validated test of either circulating tumor deoxyribonucleic acid (ctDNA) or tumor tissue in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the United Started \[US\]) or an accredited local laboratory (sites outside of the US) * Have progressed on or after osimertinib (or another approved 3rd generation epidermal growth factor receptor \[EGFR\] tyrosine kinase inhibitor \[TKI\]) and platinum-based chemotherapy (irrespective of order). a) The 3rd generation EGFR TKI must have been administered as the first EGFR TKI for metastatic disease or as the second TKI after prior treatment with first- or second-generation EGFR TKI in participants with metastatic EGFR T790M mutation positive NSCLC. b) Participants who decline or are otherwise ineligible for chemotherapy may be enrolled after discussion with the medical monitor. c) Any adjuvant or neoadjuvant treatment, whether with a 3rd generation EGFR TKI or platinum based chemotherapy, would count towards the prior treatment requirement if the participant experienced disease * Have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (RECIST) version 1.1 * Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1 * 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) Exclusion Criteria: * Participant has received cytotoxic, investigational, or targeted therapies beyond one regimen of platinum-based chemotherapy and EGFR inhibitors * Participant has received radiotherapy for palliative purposes less than 7 days prior to randomization * Participant has symptomatic or progressive brain metastases * Participant has leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation * Participant has uncontrolled tumor-related pain * Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Lazertinib 240 milligrams (mg) will be administered orally once daily. Participants will receive amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), 1600 mg/ 2240 mg depending on the body weight by manual injection. Participants benefiting from study treatment after primary analysis may continue to receive access to study treatment within the study by transferring to the long-term extension (LTE) Phase.
    intervention Names
    1. Drug: Lazertinib
    2. Drug: Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)
    label
    Arm A: Lazertinib with Amivantamab SC-CF
    type
    EXPERIMENTAL
  2. description
    Lazertinib 240 mg will be administered orally once. Participants will receive amivantamab, 1050 mg or 1400 mg depending on the body weight as an IV infusion. Participants benefiting from study treatment after primary analysis may continue to receive access to study treatment within the study by transferring to the LTE Phase.
    intervention Names
    1. Drug: Lazertinib
    2. Drug: Amivantamab Intravenous
    label
    Arm B: Lazertinib with Amivantamab Intravenous (IV) Infusion
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm A: Lazertinib with Amivantamab SC-CF
    2. Arm B: Lazertinib with Amivantamab Intravenous (IV) Infusion
    description
    Lazertinib tablets will be administered orally.
    name
    Lazertinib
    other Names
    1. JNJ-73841937
    2. YH25448
    type
    DRUG
  2. arm Group Labels
    1. Arm A: Lazertinib with Amivantamab SC-CF
    description
    Amivantamab injection will be administered subcutaneously by manual injection.
    name
    Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)
    other Names
    1. JNJ-61186372
    type
    DRUG
  3. arm Group Labels
    1. Arm B: Lazertinib with Amivantamab Intravenous (IV) Infusion
    description
    Amivantamab will be administered by IV infusion.
    name
    Amivantamab Intravenous
    other Names
    1. JNJ-61186372
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
418
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Ctrough was the observed serum concentration of Amivantamab at steady state immediately prior to the next drug administration.
    measure
    For All Regions Other Than the European Union (EU) and Others Accepting Cycle 2 Day 1: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State
    time Frame
    Pre-dose on Cycle 4 Day 1 (each cycle of 28 days)
  2. description
    Ctrough was the observed serum concentration of Amivantamab immediately prior to the next drug administration.
    measure
    For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab
    time Frame
    Pre-dose on Cycle 2 Day 1 (each cycle of 28 days)
  3. description
    AUC (Day 1-15) defined as area under the concentration time curve from Cycle 2 Day 1 to Day 15 were reported.
    measure
    Area Under the Concentration (AUC) Time Curve of Amivantamab From Day 1 to Day 15 (AUC [Day 1-15]) of Cycle 2
    time Frame
    Cycle 2: Arm A: pre-dose, 24, 48, 72, 96, 168, and 360 hours (hrs) post-dose on Day 1; Arm B: pre-infusion, end of infusion (EOI)+10 minutes, EOI+2, EOI+6, EOI+24, EOI+48, EOI+72, EOI+168, and EOI+360 hrs post dose on Day 1
secondary Outcomes
  1. measure
    Objective Response Rate (ORR)
    time Frame
    Up to 3 years 4 months
  2. measure
    Progression-Free Survival (PFS)
    time Frame
    Up to 3 years 4 months
  3. measure
    Duration of Response (DOR)
    time Frame
    Up to 3 years 4 months
  4. measure
    Time to Response (TTR)
    time Frame
    Up to 3 years 4 months
  5. measure
    Number of Participants With Adverse Events (AEs)
    time Frame
    Up to 3 years 4 months
  6. measure
    Number of Participants With AEs by Severity
    time Frame
    Up to 3 years 4 months
  7. measure
    Number of Participants With Clinical Laboratory Abnormalities
    time Frame
    Up to 3 years 4 months
  8. measure
    Number of Participants With Clinical Laboratory Abnormalities by Severity
    time Frame
    Up to 3 years 4 months
  9. measure
    Number of Participants With Infusion Related Reactions (IRRs)
    time Frame
    Up to 3 years 4 months
  10. measure
    Number of Participants With IRRs by Severity
    time Frame
    Up to 3 years 4 months
  11. measure
    For All Regions Other Than the EU and Others Accepting Cycle 2 Day 1: Observed Serum Concentration (Ctrough) of Amivantamab at Pre-dose on Cycle 2 Day 1
    time Frame
    Pre-dose on Cycle 2 Day 1 (each cycle of 28 days)
  12. measure
    For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State on Cycle 4 Day 1
    time Frame
    Pre-dose on Cycle 4 Day 1 (each cycle of 28 days)
Full study description
brief Summary
The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration.
Source references
references
  1. citation
    Leighl NB, Passaro A, Akamatsu H, Spira AI, Nguyen D, Qin A, Schuchard J, Gamil M, Baig M, Alexander M. Plain language summary of subcutaneous vs IV amivantamab plus lazertinib in EGFR-altered non-small-cell lung cancer. Future Oncol. 2026 Aug 24:1-17. doi: 10.1080/14796694.2026.2709936. Online ahead of print.
    pmid
    42635093
    type
    DERIVED
  2. citation
    Leighl NB, Akamatsu H, Lim SM, Cheng Y, Minchom AR, Marmarelis ME, Sanborn RE, Chih-Hsin Yang J, Liu B, John T, Massuti B, Spira AI, Lee SH, Wang J, Li J, Liu C, Novello S, Kondo M, Tamiya M, Korbenfeld E, Moskovitz M, Han JY, Alexander M, Joshi R, Felip E, Voon PJ, Danchaivijitr P, Hsu PC, Silva Melo Cruz FJ, Wehler T, Greillier L, Teixeira E, Nguyen D, Sabari JK, Qin A, Kowalski D, Sendur MAN, Xie J, Ghosh D, Alhadab A, Haddish-Berhane N, Clemens PL, Lorenzini P, Verheijen RB, Gamil M, Bauml JM, Baig M, Passaro A; PALOMA-3 Investigators. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. J Clin Oncol. 2024 Oct 20;42(30):3593-3605. doi: 10.1200/JCO.24.01001. Epub 2024 Jun 10.
    pmid
    38857463
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      occurrences
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        "-1"> Evidence (subcutaneous amivantamab-lazertinib):</p> <div class="pdq-content-list"><ol id="_486319"><li>The phase III <a href="/clinicaltrials/NCT05388669">PALOMA-3</a> study (NCT05388669) enrolled 418 patients with <em class="gene-name">EGFR</em>-altered advanced NSCLC who progressed after receiving osimertinib
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      2. context exact
        antamab-lazertinib):</p> <div class="pdq-content-list"><ol id="_486319"><li>The phase III <a href="/clinicaltrials/NCT05388669">PALOMA-3</a> study (NCT05388669) enrolled 418 patients with <em class="gene-name">EGFR</em>-altered advanced NSCLC who progressed after receiving osimertinib and platinum-based chemotherapy.
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      source title
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      source update dates
      1. context
        Updated: May 15, 2025
        datetime
        2025-05-15T12:00:00Z
        display
        May 15, 2025

    Preserved source evidence · Not medical advice