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NCT04988295 · STUDY IN CONTEXT

A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (E

Draft scope assessment: unclear. Attached because the study's own record names EGFR and names EGFR and describes metastatic disease. The study record does not state Exon 19 Deletion, so it may describe a different alteration of the same gene. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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).

Full analysis set (FAS) as defined in the protocol included all randomized participants, classified according to their assigned treatment arm regardless of the actual treatment received. The outcomes reported here are for main study participants. For Arm A participants, data were planned to be analyzed as a single arm collectively for the LACP and ACP-L dosing regimens.

→

primary · NOT_POSTED

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.

Source null

→

secondary · NOT_POSTED

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

Source null

→

secondary · NOT_POSTED

Main Study+ Extension Cohort: Overall Survival

Source null

→

secondary · NOT_POSTED

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

Source null

→

secondary · NOT_POSTED

Main Study+ Extension Cohort: Time to Subsequent Therapy

Source null

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

EORTC QLQ · 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)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-b2022b2b
nct id
NCT04988295
qol key
qol-0016
source section id
NCT04988295-om-0016
source outcome index
16
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
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)
measure definition
Source null
time frame
Up to 4 years 10 months
analysis role
secondary
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
PROMIS · Main Study+ Extension Cohort: Change From Baseline With Patient-Reported Outcomes Measurement Information System -Physical Function (PROMIS-PF)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-b2022b2b
nct id
NCT04988295
qol key
qol-0017
source section id
NCT04988295-om-0017
source outcome index
17
instrument
PROMIS
instrument basis
matched 'promis' in the study's own wording
scale title
Main Study+ Extension Cohort: Change From Baseline With Patient-Reported Outcomes Measurement Information System -Physical Function (PROMIS-PF)
measure definition
Source null
time frame
Up to 4 years 10 months
analysis role
secondary
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-b2022b2b
nct id
NCT04988295
trial label
A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (E
applicability
unclear
applicability note
Attached because the study's own record names EGFR and names EGFR and describes metastatic disease. The study record does not state Exon 19 Deletion, so it may describe a different alteration of the same gene. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
3
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-rybrevant-b2022b2b
    nct id
    NCT04988295
    outcome key
    om-0000
    source section id
    NCT04988295-om-0000
    source outcome index
    0
    endpoint
    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)
    endpoint definition
    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).
    time origin
    From randomization to either disease progression or death, whichever occurred first (up to 1 year 7 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full analysis set (FAS) as defined in the protocol included all randomized participants, classified according to their assigned treatment arm regardless of the actual treatment received. The outcomes reported here are for main study participants. For Arm A participants, data were planned to be analyzed as a single arm collectively for the LACP and ACP-L dosing regimens.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-rybrevant-b2022b2b
    nct id
    NCT04988295
    outcome key
    om-0001
    source section id
    NCT04988295-om-0001
    source outcome index
    1
    endpoint
    Main Study + Extension Cohort: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
    endpoint definition
    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.
    time origin
    up to 4 years 10 months
    analysis role
    primary
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-rybrevant-b2022b2b
    nct id
    NCT04988295
    outcome key
    om-0002
    source section id
    NCT04988295-om-0002
    source outcome index
    2
    endpoint
    Main Study+ Extension Cohort: Objective Response Rate as Assessed by Blinded Independent Central Review
    endpoint definition
    Main Study+ Extension Cohort: Objective Response Rate as Assessed by Blinded Independent Central Review
    time origin
    Up to 4 years 10 months
    analysis role
    secondary
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-rybrevant-b2022b2b
    nct id
    NCT04988295
    outcome key
    om-0003
    source section id
    NCT04988295-om-0003
    source outcome index
    3
    endpoint
    Main Study+ Extension Cohort: Overall Survival
    endpoint definition
    Main Study+ Extension Cohort: Overall Survival
    time origin
    Up to 4 years 10 months
    analysis role
    secondary
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-rybrevant-b2022b2b
    nct id
    NCT04988295
    outcome key
    om-0004
    source section id
    NCT04988295-om-0004
    source outcome index
    4
    endpoint
    Main Study+ Extension Cohort: Duration of Response as Assessed by Blinded Independent Central Review
    endpoint definition
    Main Study+ Extension Cohort: Duration of Response as Assessed by Blinded Independent Central Review
    time origin
    Up to 4 years 10 months
    analysis role
    secondary
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-rybrevant-b2022b2b
    nct id
    NCT04988295
    outcome key
    om-0005
    source section id
    NCT04988295-om-0005
    source outcome index
    5
    endpoint
    Main Study+ Extension Cohort: Time to Subsequent Therapy
    endpoint definition
    Main Study+ Extension Cohort: Time to Subsequent Therapy
    time origin
    Up to 4 years 10 months
    analysis role
    secondary
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-rybrevant-b2022b2b
    nct id
    NCT04988295
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Main Study: Arm A: Lazertinib + Amivantamab + Carboplatin + Pemetrexed (LACP/ACP-L)
    regimen
    LACP dosing (study start until 6 November 2022): Participants received Lazertinib 240 milligrams (mg) orally on Day 1 of each subsequent cycle, starting with Cycle 3, along with Amivantamab 1400 mg (1750 mg if body weight greater than or equal to \[\>=80\] kilograms \[kg\]) on Cycle 1 Days 1, 2, 8, and 15, and Cycle 2 Day 1 and 1750 mg (2100 mg if body weight \>=80 kg). Participant also received Pemetrexed 500 mg per square meter (mg/m\^2) on Day 1 21-day cycle, in combination with carboplatin 750 mg as IV infusion starting on Cycle 1 Day 1 for 4 cycles. From cycle 5 onwards, participants received Amivantamab, Pemetrexed and Lazertinib IV infusions at same dose, as maintenance until disease progression. ACP-L dosing (from 7 November 2022 until study completion): Participants received Amivantamab 1400 mg (1750 mg if body weight \>=80\] kg) on Cycle 1 Days 1,2, 8, and 15, and Cycle 2 Day 1 and 1750 mg (2100 mg if body weight \>=80 kg). Participant also received Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle, in combination with carboplatin 750 mg as IV infusion starting on Cycle 1 Day 1 for 4 cycles. Lazertinib 240 mg in ACP-L started on Cycle 5 Day 1 or sooner if carboplatin is discontinued before cycle 4. From cycle 5 onwards, participants received Amivantamab, Pemetrexed and Lazertinib IV infusions at same dose, as maintenance until disease progression. Each cycle consists of 21 days.
    analyzed count
    263
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04988295-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-rybrevant-b2022b2b
    nct id
    NCT04988295
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Main Study: Arm B: Carboplatin + Pemetrexed (CP)
    regimen
    Participants received Pemetrexed 500 mg/m\^2 IV infusion and carboplatin 750 mg IV infusion from Day 1 of Cycle 1 to 4. From cycle 5 onwards, participants received Pemetrexed 500 mg/m\^2 IV infusion, as maintenance until disease progression. Each cycle consists of 21 days.
    analyzed count
    263
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04988295-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-rybrevant-b2022b2b
    nct id
    NCT04988295
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Main Study: Arm C: Amivantamab + Carboplatin + Pemetrexed (ACP)
    regimen
    Participants received Amivantamab 1400 mg (1750 mg if body weight \>=80 kg) on Cycle 1 Days 1,2, 8, and 15, and Cycle 2 Day 1 and 1750 mg (2100 mg if body weight \>=80 kg) on Day 1 of each cycle, starting with Cycle 3. Participants also received Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle, in combination with carboplatin 750 mg as IV infusion starting on Cycle 1 Day 1 for 4 cycles. From cycle 5 onwards, participants received Amivantamab and Pemetrexed IV infusions at same dose, as maintenance until disease progression. Each cycle consists of 21 days.
    analyzed count
    131
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04988295-om-0000#groups/OG002
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-rybrevant-b2022b2b
    nct id
    NCT04988295
    harm key
    EG000
    source section id
    NCT04988295-ae
    event group key
    EG000
    event group label
    Main Study: Arm A: Lazertinib + Amivantamab + Carboplatin + Pemetrexed (LACP/ACP-L)
    serious affected
    137
    serious at risk
    263
    other affected
    261
    other at risk
    263
    frequency threshold
    5
    collection period
    From Cycle 1 Day 1 up to 1 year 7 months
    event definition
    SAEs \& Other AEs:safety set-randomized participants who had at least 1 dose of study drug. All-cause mortality:FAS-all randomized participants, classified per assigned drug regardless of actual drug received. As per statistical analysis, Arm A AE planned to be collected and analyzed as single arm regardless of regimen LACP/ACP-L received. Since extension cohort is ongoing and its data collection and analysis was not planned for primary analysis, AE data will be reported after study completion.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-rybrevant-b2022b2b
    nct id
    NCT04988295
    harm key
    EG001
    source section id
    NCT04988295-ae
    event group key
    EG001
    event group label
    Main Study: Arm B: Carboplatin + Pemetrexed (CP)
    serious affected
    49
    serious at risk
    243
    other affected
    222
    other at risk
    243
    frequency threshold
    5
    collection period
    From Cycle 1 Day 1 up to 1 year 7 months
    event definition
    SAEs \& Other AEs:safety set-randomized participants who had at least 1 dose of study drug. All-cause mortality:FAS-all randomized participants, classified per assigned drug regardless of actual drug received. As per statistical analysis, Arm A AE planned to be collected and analyzed as single arm regardless of regimen LACP/ACP-L received. Since extension cohort is ongoing and its data collection and analysis was not planned for primary analysis, AE data will be reported after study completion.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-rybrevant-b2022b2b
    nct id
    NCT04988295
    harm key
    EG002
    source section id
    NCT04988295-ae
    event group key
    EG002
    event group label
    Main Study: Arm C: Amivantamab + Carboplatin + Pemetrexed (ACP)
    serious affected
    42
    serious at risk
    130
    other affected
    129
    other at risk
    130
    frequency threshold
    5
    collection period
    From Cycle 1 Day 1 up to 1 year 7 months
    event definition
    SAEs \& Other AEs:safety set-randomized participants who had at least 1 dose of study drug. All-cause mortality:FAS-all randomized participants, classified per assigned drug regardless of actual drug received. As per statistical analysis, Arm A AE planned to be collected and analyzed as single arm regardless of regimen LACP/ACP-L received. Since extension cohort is ongoing and its data collection and analysis was not planned for primary analysis, AE data will be reported after study completion.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-rybrevant-b2022b2b
    nct id
    NCT04988295
    qol key
    qol-0016
    source section id
    NCT04988295-om-0016
    source outcome index
    16
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    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)
    measure definition
    Source null
    time frame
    Up to 4 years 10 months
    analysis role
    secondary
    reporting status
    NOT_POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-rybrevant-b2022b2b
    nct id
    NCT04988295
    qol key
    qol-0017
    source section id
    NCT04988295-om-0017
    source outcome index
    17
    instrument
    PROMIS
    instrument basis
    matched 'promis' in the study's own wording
    scale title
    Main Study+ Extension Cohort: Change From Baseline With Patient-Reported Outcomes Measurement Information System -Physical Function (PROMIS-PF)
    measure definition
    Source null
    time frame
    Up to 4 years 10 months
    analysis role
    secondary
    reporting status
    NOT_POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice