TriangleNCT04487080 · STUDY IN CONTEXT
A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally 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
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) the absence of progression, whichever came first. Disease progression was defined using RECIST 1.1 as a 20 percent (%) increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 millimeters (mL). 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.
Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause.
ORR is defined as the percentage of participants who achieve either a complete response (CR) or partial response (PR) as defined by BICR using RECIST v1.1 criteria.
DOR is defined as the time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, only for participants who achieve CR or PR as determined by the investigator using RECIST v1.1 criteria.
The PFS2 is defined as the time from randomization until the date of second objective disease progression, after initiation of subsequent anticancer therapy, based on investigator assessment (after that used for PFS) or death, whichever comes first.
TTSP is defined as the time from randomization to documentation in the electronic case report form (eCRF) of any of the following (whichever occurs earlier): onset of new symptoms or symptom worsening that is considered by the investigator to be related to lung cancer and requires either a change in anticancer treatment and/or clinical intervention to manage symptoms.
Reported safety
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-faspro-964accb6
- nct id
- NCT04487080
- qol key
- qol-0015
- source section id
- NCT04487080-om-0015
- source outcome index
- 15
- 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
- EORTC-QLQ-C30 is a core 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies.
- time frame
- Baseline up to approximately 60 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
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
- nct id
- NCT04487080
- trial label
- A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally 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
- 3
- qol Count
- 1
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
- nct id
- NCT04487080
- outcome key
- om-0000
- source section id
- NCT04487080-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) the absence of progression, whichever came first. Disease progression was defined using RECIST 1.1 as a 20 percent (%) increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 millimeters (mL). 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.
- time origin
- From randomization to either disease progression or death whichever occurs first (up to 32.8 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full analysis set (FAS) 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
- nct id
- NCT04487080
- outcome key
- om-0001
- source section id
- NCT04487080-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival (OS)
- endpoint definition
- Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause.
- time origin
- Approximately 60 months (time from the date of randomization until the date of death due to any cause)
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
- nct id
- NCT04487080
- outcome key
- om-0002
- source section id
- NCT04487080-om-0002
- source outcome index
- 2
- endpoint
- Objective Response Rate (ORR)
- endpoint definition
- ORR is defined as the percentage of participants who achieve either a complete response (CR) or partial response (PR) as defined by BICR using RECIST v1.1 criteria.
- time origin
- Approximately 32.8 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
- nct id
- NCT04487080
- outcome key
- om-0003
- source section id
- NCT04487080-om-0003
- source outcome index
- 3
- endpoint
- Duration of Response (DOR)
- endpoint definition
- DOR is defined as the time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, only for participants who achieve CR or PR as determined by the investigator using RECIST v1.1 criteria.
- time origin
- Approximately 32.8 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
- nct id
- NCT04487080
- outcome key
- om-0004
- source section id
- NCT04487080-om-0004
- source outcome index
- 4
- endpoint
- Progression-Free Survival After First Subsequent Therapy (PFS2)
- endpoint definition
- The PFS2 is defined as the time from randomization until the date of second objective disease progression, after initiation of subsequent anticancer therapy, based on investigator assessment (after that used for PFS) or death, whichever comes first.
- time origin
- Approximately 60 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
- nct id
- NCT04487080
- outcome key
- om-0005
- source section id
- NCT04487080-om-0005
- source outcome index
- 5
- endpoint
- Time to Symptomatic Progression (TTSP)
- endpoint definition
- TTSP is defined as the time from randomization to documentation in the electronic case report form (eCRF) of any of the following (whichever occurs earlier): onset of new symptoms or symptom worsening that is considered by the investigator to be related to lung cancer and requires either a change in anticancer treatment and/or clinical intervention to manage symptoms.
- time origin
- Approximately 60 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
- nct id
- NCT04487080
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Experimental: Arm A (Open-label): Amivantamab + Lazertinib
- regimen
- Participants received combination therapy of amivantamab 1050 milligrams (mg) for body weight (BW) less than (\<) 80 kilograms (kg) or 1400 mg for BW greater than or equal to (\>=) 80 kg intravenous (IV) infusion once weekly in 28-day treatment cycles: at Cycle 1 Days 1/2 (split dose, Day 1: 350 mg regardless of BW; Day 2: 700 mg or 1050 mg \[if BW \>=80 kg\]), 8, 15, and 22 and then once every 2 weeks (at Day 1 and 15) from Cycle 2 onwards; and lazertinib 240 mg (3 tablets of 80 mg) orally once daily. Participants continued treatment until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.
- analyzed count
- 429
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04487080-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
- nct id
- NCT04487080
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Active Comparator: Arm B (Double-blind): Osimertinib+Placebo Matching Lazertinib
- regimen
- Participants received osimertinib 80 mg capsule orally once daily along with 3 tablets of matching placebo of lazertinib 240 mg tablets orally once daily from Cycle 1 Day 1 until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.
- analyzed count
- 429
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04487080-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
- nct id
- NCT04487080
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Experimental: Arm C (Double-blind): Lazertinib+Placebo Matching Osimertinib
- regimen
- Participants received lazertinib 240 mg (3 tablets of 80 mg) orally once daily along with single capsule of matching placebo of osimertinib 80 mg orally once daily from Cycle 1 Day 1 until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.
- analyzed count
- 216
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04487080-om-0000#groups/OG002
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
- nct id
- NCT04487080
- harm key
- EG000
- source section id
- NCT04487080-ae
- event group key
- EG000
- event group label
- Experimental: Arm A (Open-label): Amivantamab + Lazertinib
- serious affected
- 205
- serious at risk
- 421
- other affected
- 419
- other at risk
- 421
- frequency threshold
- 5
- collection period
- From baseline (Day 1 of Cycle 1) up to 32.8 months
- event definition
- The safety set included 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
- nct id
- NCT04487080
- harm key
- EG001
- source section id
- NCT04487080-ae
- event group key
- EG001
- event group label
- Active Comparator: Arm B (Double-blind): Osimertinib+Placebo Matching Lazertinib
- serious affected
- 143
- serious at risk
- 428
- other affected
- 409
- other at risk
- 428
- frequency threshold
- 5
- collection period
- From baseline (Day 1 of Cycle 1) up to 32.8 months
- event definition
- The safety set included 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
- nct id
- NCT04487080
- harm key
- EG002
- source section id
- NCT04487080-ae
- event group key
- EG002
- event group label
- Experimental: Arm C (Double-blind): Lazertinib+Placebo Matching Osimertinib
- serious affected
- 75
- serious at risk
- 213
- other affected
- 210
- other at risk
- 213
- frequency threshold
- 5
- collection period
- From baseline (Day 1 of Cycle 1) up to 32.8 months
- event definition
- The safety set included 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
- nct id
- NCT04487080
- qol key
- qol-0015
- source section id
- NCT04487080-om-0015
- source outcome index
- 15
- 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
- EORTC-QLQ-C30 is a core 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies.
- time frame
- Baseline up to approximately 60 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