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NCT04988295 · CITED IN SOURCE DOCUMENTS

A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure

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
2026-08-20

The purpose of this study is to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP) in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure. The purpose of the extension cohort is to further describe the safety and efficacy for the ACP-L dosing schedule versus ACP with additional data. After completion of the primary analysis, the study may eventually transition to an open-label extension (OLE) or long-term extension (LTE) phase during which participants will have the option to continue their assigned treatment.

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

Main Study: Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)

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outcome · NOT POSTED

Main Study + Extension Cohort: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

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outcome · NOT POSTED

Main Study+ Extension Cohort: Objective Response Rate as Assessed by Blinded Independent Central Review

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outcome · NOT POSTED

Main Study+ Extension Cohort: Overall Survival

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outcome · NOT POSTED

Main Study+ Extension Cohort: Duration of Response as Assessed by Blinded Independent Central Review

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outcome · NOT POSTED

Main Study+ Extension Cohort: Time to Subsequent Therapy

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outcome · NOT POSTED

Main Study+ Extension Cohort: Progression-free Survival (PFS) After First Subsequent Therapy (PFS2)

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outcome · NOT POSTED

Main Study+ Extension Cohort: Time to Symptomatic Progression

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outcome · NOT POSTED

Main Study+ Extension Cohort: Intracranial Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review

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outcome · NOT POSTED

Main Study: Number of Participants With Adverse Events (AEs)

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outcome · NOT POSTED

Main Study+ Extension Cohort: Number of Participants With Adverse Events (AEs) by Severity

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outcome · NOT POSTED

Main Study+ Extension Cohort: Number of Participants With Clinical Laboratory Abnormalities

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outcome · NOT POSTED

Main Study+ Extension Cohort: Serum Concentration of Amivantamab

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outcome · NOT POSTED

Main Study+ Extension Cohort: Plasma Concentration of Lazertinib

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outcome · NOT POSTED

Main Study + Extension Cohort: Number of Participants With Serum Anti-amivantamab Antibodies

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outcome · NOT POSTED

Main Study+ Extension Cohort: Change From Baseline With Non-Small Cell Lung Cancer - Symptom Assessment Questionnaire (NSCLC-SAQ)

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outcome · NOT POSTED

Main Study+ Extension Cohort: Change From Baseline With European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)

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outcome · NOT POSTED

Main Study+ Extension Cohort: Change From Baseline With Patient-Reported Outcomes Measurement Information System -Physical Function (PROMIS-PF)

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outcome · NOT POSTED

Main Study + Extension Cohort: Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review

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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: * Participant must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated * Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC), characterized at or after the time of locally advanced or metastatic disease diagnosis by either epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R mutation * A participant with a history of brain metastases must have had all lesions treated as clinically indicated (that is, no current indication for further definitive local therapy). Any definitive local therapy to brain metastases must have been completed at least 14 days prior to randomization and the participant can be receiving no greater than10 milligrams (mg) prednisone or equivalent daily for the treatment of intracranial disease * Participant must have Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 * Any toxicities from prior systemic anticancer therapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 Grade 1 or baseline level (except for alopecia \[any grade\], Grade \<= 2 peripheral neuropathy, or Grade \<= 2 hypothyroidism stable on hormone replacement) * A participant of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study * Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment. Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second- line setting after prior treatment with first- or second-generation EGFR tyrosine kinase inhibitor (TKI) as a monotherapy. Participants who received either neoadjuvant and/or adjuvant treatment of any type are eligible if progression to locally advanced or metastatic disease occurred at least 12 months after the last dose of such therapy and then the participant progressed on or after osimertinib in the locally advanced or metastatic setting. Treatment with osimertinib must be discontinued at least 8 days (4 half-lives) prior to randomization (that is last dose no later than Day -8) Exclusion Criteria: * Participant received radiotherapy for palliative treatment of NSCLC less than 14 days prior to randomization * Participant with symptomatic or progressive brain metastases * Participant has history of or current evidence of leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation * Participant has known small cell transformation * Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis * Participant has a history of clinically significant cardiovascular disease including, but not limited to diagnosis of deep vein thrombosis or pulmonary embolism within 4 weeks prior to randomization; myocardial infarction; unstable angina; stroke; transient ischemic attack; coronary/peripheral artery bypass graft; or acute coronary syndrome. Participant has a significant genetic predisposition to venous thromboembolic events. Participant has a prior history of venous thromboembolic events and is not on appropriate therapeutic anticoagulation as per National Comprehensive Cancer Network or local guidelines
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    LACP dosing (study start until 6 November 2022): Participants will receive Lazertinib orally along with Amivantamab, Pemetrexed, and Carboplatin as IV infusion starting on Cycle 1 Day 1 for 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Amivantamab, Pemetrexed and Lazertinib as maintenance until disease progression. ACP-L dosing (from 7 November 2022 until study completion): Participants will receive Amivantamab, Pemetrexed, and Carboplatin starting on Cycle 1 Day 1 for 4 cycles. Lazertinib in ACP-L will start on Cycle 5 Day 1 or sooner if carboplatin is discontinued before cycle 4 (each cycle consists of 21 days). Beginning with Cycle 5 Day 1, participants will receive Amivantamab, Pemetrexed and Lazertinib as maintenance until disease progression.
    intervention Names
    1. Drug: Lazertinib
    2. Drug: Amivantamab
    3. Drug: Pemetrexed
    4. Drug: Carboplatin
    label
    Arm A: LACP/ACP-L
    type
    EXPERIMENTAL
  2. description
    Participants will receive Pemetrexed in combination with Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Pemetrexed as maintenance until disease progression.
    intervention Names
    1. Drug: Pemetrexed
    2. Drug: Carboplatin
    label
    Arm B: CP (Carboplatin and Pemetrexed)
    type
    ACTIVE_COMPARATOR
  3. description
    Participants will receive Amivantamab, Pemetrexed, and Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Amivantamab and Pemetrexed as maintenance until disease progression.
    intervention Names
    1. Drug: Amivantamab
    2. Drug: Pemetrexed
    3. Drug: Carboplatin
    label
    Arm C: ACP (Amivantamab, Carboplatin and Pemetrexed)
    type
    EXPERIMENTAL
  4. description
    Participants will receive Amivantamab, Pemetrexed and Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days), Lazertinib will start on C5D1 or sooner if carboplatin is discontinued earlier). After 4 cycles, participants will receive Pemetrexed, Amivantamab, Lazertinib as maintenance until disease progression.
    intervention Names
    1. Drug: Lazertinib
    2. Drug: Amivantamab
    3. Drug: Pemetrexed
    4. Drug: Carboplatin
    label
    Arm A2 (Extension Cohort): ACP-L
    type
    EXPERIMENTAL
  5. description
    Participants will receive Amivantamab, Pemetrexed, and Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Amivantamab and Pemetrexed as maintenance until disease progression.
    intervention Names
    1. Drug: Amivantamab
    2. Drug: Pemetrexed
    3. Drug: Carboplatin
    label
    Arm C2 (Extension Cohort): ACP
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm A2 (Extension Cohort): ACP-L
    2. Arm A: LACP/ACP-L
    description
    Lazertinib will be administered orally.
    name
    Lazertinib
    other Names
    1. JNJ-73841937
    2. YH-25448
    type
    DRUG
  2. arm Group Labels
    1. Arm A2 (Extension Cohort): ACP-L
    2. Arm A: LACP/ACP-L
    3. Arm C2 (Extension Cohort): ACP
    4. Arm C: ACP (Amivantamab, Carboplatin and Pemetrexed)
    description
    Amivantamab will be administered as an IV infusion.
    name
    Amivantamab
    other Names
    1. JNJ-61186372
    type
    DRUG
  3. arm Group Labels
    1. Arm A2 (Extension Cohort): ACP-L
    2. Arm A: LACP/ACP-L
    3. Arm B: CP (Carboplatin and Pemetrexed)
    4. Arm C2 (Extension Cohort): ACP
    5. Arm C: ACP (Amivantamab, Carboplatin and Pemetrexed)
    description
    Pemetrexed will be administered as an IV infusion.
    name
    Pemetrexed
    type
    DRUG
  4. arm Group Labels
    1. Arm A2 (Extension Cohort): ACP-L
    2. Arm A: LACP/ACP-L
    3. Arm B: CP (Carboplatin and Pemetrexed)
    4. Arm C2 (Extension Cohort): ACP
    5. Arm C: ACP (Amivantamab, Carboplatin and Pemetrexed)
    description
    Carboplatin will be administered as an IV infusion.
    name
    Carboplatin
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
776
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    PFS is defined as the time from randomization until the date of objective disease progression or death, whichever came first, as assessed by BICR according to RECIST version 1.1. Progressed disease: Sum of diameters increased by greater than or equal to (\>=)20 percent (%) and \>=5 millimeter (mm) from nadir (including baseline if it was smallest sum).
    measure
    Main Study: Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)
    time Frame
    From randomization to either disease progression or death, whichever occurred first (up to 1 year 7 months)
  2. description
    Follow-up for the extension cohort is still ongoing and thus results from the analysis that includes the extension cohort will be reported up on study completion.
    measure
    Main Study + Extension Cohort: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
    time Frame
    up to 4 years 10 months
  3. measure
    Main Study + Extension Cohort: Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review
    time Frame
    Up to 4 years 10 months
secondary Outcomes
  1. measure
    Main Study+ Extension Cohort: Objective Response Rate as Assessed by Blinded Independent Central Review
    time Frame
    Up to 4 years 10 months
  2. measure
    Main Study+ Extension Cohort: Overall Survival
    time Frame
    Up to 4 years 10 months
  3. measure
    Main Study+ Extension Cohort: Duration of Response as Assessed by Blinded Independent Central Review
    time Frame
    Up to 4 years 10 months
  4. measure
    Main Study+ Extension Cohort: Time to Subsequent Therapy
    time Frame
    Up to 4 years 10 months
  5. measure
    Main Study+ Extension Cohort: Progression-free Survival (PFS) After First Subsequent Therapy (PFS2)
    time Frame
    Up to 4 years 10 months
  6. measure
    Main Study+ Extension Cohort: Time to Symptomatic Progression
    time Frame
    Up to 4 years 10 months
  7. measure
    Main Study+ Extension Cohort: Intracranial Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review
    time Frame
    Up to 4 years 10 months
  8. measure
    Main Study: Number of Participants With Adverse Events (AEs)
    time Frame
    Up to 4 years 10 months
  9. measure
    Main Study+ Extension Cohort: Number of Participants With Adverse Events (AEs) by Severity
    time Frame
    Up to 4 years 10 months
  10. measure
    Main Study+ Extension Cohort: Number of Participants With Clinical Laboratory Abnormalities
    time Frame
    Up to 4 years 10 months
  11. measure
    Main Study+ Extension Cohort: Serum Concentration of Amivantamab
    time Frame
    Up to 4 years 10 months
  12. measure
    Main Study+ Extension Cohort: Plasma Concentration of Lazertinib
    time Frame
    Up to 4 years 10 months
Full study description
brief Summary
The purpose of this study is to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP) in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure. The purpose of the extension cohort is to further describe the safety and efficacy for the ACP-L dosing schedule versus ACP with additional data. After completion of the primary analysis, the study may eventually transition to an open-label extension (OLE) or long-term extension (LTE) phase during which participants will have the option to continue their assigned treatment.
Source references
Source notices and limitations
    Discovery and provenance
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        -1">Evidence (amivantamab plus chemotherapy):</p> <div class="pdq-content-list"><ol id="_486276"><li>The global phase III <a href="/clinicaltrials/NCT04988295">MARIPOSA-2</a> trial (NCT04988295) included 657 patients with locally advanced or metastatic NSCLC and <em class="gene-name">EGFR</em> variants (<em class="g
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        otherapy):</p> <div class="pdq-content-list"><ol id="_486276"><li>The global phase III <a href="/clinicaltrials/NCT04988295">MARIPOSA-2</a> trial (NCT04988295) included 657 patients with locally advanced or metastatic NSCLC and <em class="gene-name">EGFR</em> variants (<em class="gene-name">EGFR</em> exon 19 deletio
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        with Carboplatin and Pemetrexed MARIPOSA-2 The efficacy of intravenous amivantamab in combination with carboplatin and pemetrexed was evaluated in MARIPOSA-2 (NCT04988295), a randomized, open-label, multicenter trial. Eligible patients were required to have locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon
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      occurrences
      1. context exact
        ions or Exon 21 L858R Substitution Mutations - MARIPOSA-2 The efficacy of RYBREVANT in combination with carboplatin and pemetrexed was evaluated in MARIPOSA-2 (NCT04988295), a randomized, open-label, multicenter trial. Eligible patients were required to have locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon
        end
        5957
        exact text
        NCT04988295
        start
        5946
      offset unit
      unicode_code_points
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      source file sha256
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      source json pointer
      /results/80/clinical_studies/0
      source kind
      fda_spl_label
      source record id
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      source string basis
      parsed_JSON_string_unmodified
      source string sha256
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      source url
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      spl effective time
      20251111
      spl set id
      1466c070-9f97-4fa4-a955-6a6b59981fb8

    Preserved source evidence · Not medical advice