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← Rybrevant: metastatic Non-small cell lung cancer with EGFR Exon 19 Deletion, EGFR stated without a specific alteration (first-line)

NCT04538664 · STUDY IN CONTEXT

A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer

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 was defined as the time from randomization until the date of objective disease progression based on BICR using RECIST version 1.1 or death (by any cause) in the absence of progression, whichever came first. Participants who have not progressed or have not died at the time of analysis were censored at the time of the latest date of their last evaluable RECIST version 1.1 assessment. Pharmacodynamic: 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 included all randomized participants, classified according to their assigned treatment arm regardless of the actual treatment received.

→

secondary · NOT_POSTED

Objective Response Rate (ORR)

Source null

→

secondary · NOT_POSTED

Duration of Response (DoR)

Source null

→

secondary · NOT_POSTED

Overall Survival (OS)

Source null

→

secondary · NOT_POSTED

Time to Subsequent Therapy (TST)

Source null

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secondary · NOT_POSTED

Progression-Free Survival After First Subsequent Therapy (PFS2)

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 · Change From Baseline in European Organization of 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
NCT04538664
qol key
qol-0014
source section id
NCT04538664-om-0014
source outcome index
14
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
measure definition
Source null
time frame
From baseline to 5 years 3 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 · Change From Baseline in 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
NCT04538664
qol key
qol-0015
source section id
NCT04538664-om-0015
source outcome index
15
instrument
PROMIS
instrument basis
matched 'promis' in the study's own wording
scale title
Change From Baseline in Patient Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF)
measure definition
Source null
time frame
From baseline to 5 years 3 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
NCT04538664
trial label
A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer
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
2
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-rybrevant-b2022b2b
    nct id
    NCT04538664
    outcome key
    om-0000
    source section id
    NCT04538664-om-0000
    source outcome index
    0
    endpoint
    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 was defined as the time from randomization until the date of objective disease progression based on BICR using RECIST version 1.1 or death (by any cause) in the absence of progression, whichever came first. Participants who have not progressed or have not died at the time of analysis were censored at the time of the latest date of their last evaluable RECIST version 1.1 assessment. Pharmacodynamic: 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 occurs first (up to 29 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full analysis set included all randomized participants, classified according to their assigned treatment arm regardless of the actual treatment received.
    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
    NCT04538664
    outcome key
    om-0001
    source section id
    NCT04538664-om-0001
    source outcome index
    1
    endpoint
    Objective Response Rate (ORR)
    endpoint definition
    Objective Response Rate (ORR)
    time origin
    Up to 5 years 3 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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-rybrevant-b2022b2b
    nct id
    NCT04538664
    outcome key
    om-0002
    source section id
    NCT04538664-om-0002
    source outcome index
    2
    endpoint
    Duration of Response (DoR)
    endpoint definition
    Duration of Response (DoR)
    time origin
    Up to 5 years 3 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
    NCT04538664
    outcome key
    om-0003
    source section id
    NCT04538664-om-0003
    source outcome index
    3
    endpoint
    Overall Survival (OS)
    endpoint definition
    Overall Survival (OS)
    time origin
    Up to 5 years 3 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
    NCT04538664
    outcome key
    om-0004
    source section id
    NCT04538664-om-0004
    source outcome index
    4
    endpoint
    Time to Subsequent Therapy (TST)
    endpoint definition
    Time to Subsequent Therapy (TST)
    time origin
    Up to 5 years 3 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
    NCT04538664
    outcome key
    om-0005
    source section id
    NCT04538664-om-0005
    source outcome index
    5
    endpoint
    Progression-Free Survival After First Subsequent Therapy (PFS2)
    endpoint definition
    Progression-Free Survival After First Subsequent Therapy (PFS2)
    time origin
    Up to 5 years 3 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
    NCT04538664
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm B: Chemotherapy Alone
    regimen
    Participants received chemotherapy with pemetrexed 500 milligrams per meter square (mg/m\^2) Intraveous (IV) infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin area under the concentration-time curve of 5 (AUC 5) IV infusion administered on Day 1 for up to 4 cycles, and then as maintenance monotherapy until disease progression. Following the primary analysis, the study was transitioned to an open-label extension (OLE) phase, and participants either continued to receive the chemotherapy or crossover to amivantamab in the OLE phase.
    analyzed count
    155
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04538664-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-rybrevant-b2022b2b
    nct id
    NCT04538664
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm A: Amivantamab + Chemotherapy
    regimen
    Participants received amivantamab 1400 milligrams (mg) (1750 mg if body weight is greater than or equal to (\>=) 80 kilograms \[kg\]) by IV infusion once weekly starting from Cycle 1 Day 1 up to Cycle 2 Day 1, then 1750 mg (2100 mg if body weight is \>=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3 up to Cycle 5 Day 1. Participants received chemotherapy with pemetrexed 500 mg/m\^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin area under the concentration-time curve of 5 milligrams per milliliter (mg/mL) per minute (AUC 5) was administered as an IV infusion on Day 1, for up to 4 cycles, and then as maintenance monotherapy until disease progression. Following the primary analysis, the study was transitioned to an OLE phase, and participants continued to receive amivantamab plus chemotherapy in the OLE phase.
    analyzed count
    153
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04538664-om-0000#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-rybrevant-b2022b2b
    nct id
    NCT04538664
    harm key
    EG000
    source section id
    NCT04538664-ae
    event group key
    EG000
    event group label
    Arm B: Chemotherapy Alone
    serious affected
    48
    serious at risk
    155
    other affected
    149
    other at risk
    155
    frequency threshold
    5
    collection period
    From baseline (Day 1 of Cycle 1) up to 29 months
    event definition
    The safety set included all randomized participants who received at least 1 dose of study treatment.
    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
    NCT04538664
    harm key
    EG001
    source section id
    NCT04538664-ae
    event group key
    EG001
    event group label
    Arm A: Amivantamab + Chemotherapy
    serious affected
    56
    serious at risk
    151
    other affected
    151
    other at risk
    151
    frequency threshold
    5
    collection period
    From baseline (Day 1 of Cycle 1) up to 29 months
    event definition
    The safety set included all randomized participants who received at least 1 dose of study treatment.
    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
    NCT04538664
    qol key
    qol-0014
    source section id
    NCT04538664-om-0014
    source outcome index
    14
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Change From Baseline in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
    measure definition
    Source null
    time frame
    From baseline to 5 years 3 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
    NCT04538664
    qol key
    qol-0015
    source section id
    NCT04538664-om-0015
    source outcome index
    15
    instrument
    PROMIS
    instrument basis
    matched 'promis' in the study's own wording
    scale title
    Change From Baseline in Patient Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF)
    measure definition
    Source null
    time frame
    From baseline to 5 years 3 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