TriangleNCT05388669 · STUDY IN CONTEXT
A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastati
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
Ctrough was the observed serum concentration of Amivantamab at steady state immediately prior to the next drug administration.
Ctrough was the observed serum concentration of Amivantamab immediately prior to the next drug administration.
AUC (Day 1-15) defined as area under the concentration time curve from Cycle 2 Day 1 to Day 15 were reported.
Objective Response Rate (ORR)
Progression-Free Survival (PFS)
Duration of Response (DOR)
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
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
- NCT05388669
- trial label
- A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastati
- 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
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-rybrevant-b2022b2b
- nct id
- NCT05388669
- outcome key
- om-0000
- source section id
- NCT05388669-om-0000
- source outcome index
- 0
- endpoint
- 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
- endpoint definition
- Ctrough was the observed serum concentration of Amivantamab at steady state immediately prior to the next drug administration.
- time origin
- Pre-dose on Cycle 4 Day 1 (each cycle of 28 days)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The pharmacokinetic (PK) primary endpoint evaluable set included all randomized participants who had received all doses in Cycle 1-3, without dose modifications and provided Cycle 4 Day 1 Ctrough. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
- 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-b2022b2b
- nct id
- NCT05388669
- outcome key
- om-0001
- source section id
- NCT05388669-om-0001
- source outcome index
- 1
- endpoint
- For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab
- endpoint definition
- Ctrough was the observed serum concentration of Amivantamab immediately prior to the next drug administration.
- time origin
- Pre-dose on Cycle 2 Day 1 (each cycle of 28 days)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The PK primary endpoint evaluable set included all randomized participants who had received all doses in Cycle 1, without dose modifications and provided Cycle 2 Day 1 Ctrough. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
- 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-b2022b2b
- nct id
- NCT05388669
- outcome key
- om-0002
- source section id
- NCT05388669-om-0002
- source outcome index
- 2
- endpoint
- Area Under the Concentration (AUC) Time Curve of Amivantamab From Day 1 to Day 15 (AUC [Day 1-15]) of Cycle 2
- endpoint definition
- AUC (Day 1-15) defined as area under the concentration time curve from Cycle 2 Day 1 to Day 15 were reported.
- time origin
- 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
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The PK primary endpoint evaluable set included all randomized participants who had received all doses up to Cycle 2 Day 1, without dose modifications and provided all necessary PK samples to derive primary PK endpoint Cycle 2 AUC(D1-D15). Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
- 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-b2022b2b
- nct id
- NCT05388669
- outcome key
- om-0003
- source section id
- NCT05388669-om-0003
- source outcome index
- 3
- endpoint
- Objective Response Rate (ORR)
- endpoint definition
- Objective Response Rate (ORR)
- time origin
- Up to 3 years 4 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-b2022b2b
- nct id
- NCT05388669
- outcome key
- om-0004
- source section id
- NCT05388669-om-0004
- source outcome index
- 4
- endpoint
- Progression-Free Survival (PFS)
- endpoint definition
- Progression-Free Survival (PFS)
- time origin
- Up to 3 years 4 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-b2022b2b
- nct id
- NCT05388669
- outcome key
- om-0005
- source section id
- NCT05388669-om-0005
- source outcome index
- 5
- endpoint
- Duration of Response (DOR)
- endpoint definition
- Duration of Response (DOR)
- time origin
- Up to 3 years 4 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-b2022b2b
- nct id
- NCT05388669
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm A: Lazertinib With Amivantamab SC-CF
- regimen
- Participants were administered lazertinib 240 milligrams (mg) tablet orally once daily from Cycle 1 Day 1 until Cycle 15, with each cycle consisting of 28 days. Participants then received amivantamab subcutaneous injection with at dose 1600 mg (if body weight \[BW\] is less than \[\<\] 80 kilograms \[kg\]) or 2240 mg (if BW is greater than or equal to \[\>=\] 80 kg) co-formulated (SC-CF) with recombinant human hyaluronidase PH20 (rHuPH20) 160 milligrams per milliliter (mg/mL) through manual injection on Cycle 1 Days 1, 8, 15, and 22, and on Days 1 and 15 of each subsequent cycle, starting from Cycle 2. After the completion of primary analysis, participants who benefited from the study treatment continued their treatment within the study upon transitioning into the LTE phase.
- analyzed count
- 98
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05388669-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-rybrevant-b2022b2b
- nct id
- NCT05388669
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion
- regimen
- Participants were administered lazertinib 240 mg orally once daily from Cycle 1 Day 1 until Cycle 15, with each cycle consisting of 28 days. Participants then received amivantamab intravenous infusion at dose 1050 mg (if BW\< 80 kg) or 1400 mg (if BW \>=80 kg) on Cycle 1 Days 1-2 (split dose), 8, 15, 22, and on Days 1 and 15 of each subsequent cycle, starting from Cycle 2. After the completion of primary analysis, participants who benefited from the study treatment continued their treatment within the study upon transitioning into the LTE phase.
- analyzed count
- 98
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05388669-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-rybrevant-b2022b2b
- nct id
- NCT05388669
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm A: Lazertinib With Amivantamab SC-CF
- regimen
- Participants were administered lazertinib 240 milligrams (mg) tablet orally once daily from Cycle 1 Day 1 until Cycle 15, with each cycle consisting of 28 days. Participants then received amivantamab subcutaneous injection with at dose 1600 mg (if body weight \[BW\] is less than \[\<\] 80 kilograms \[kg\]) or 2240 mg (if BW is greater than or equal to \[\>=\] 80 kg) co-formulated (SC-CF) with recombinant human hyaluronidase PH20 (rHuPH20) 160 milligrams per milliliter (mg/mL) through manual injection on Cycle 1 Days 1, 8, 15, and 22, and on Days 1 and 15 of each subsequent cycle, starting from Cycle 2. After the completion of primary analysis, participants who benefited from the study treatment continued their treatment within the study upon transitioning into the LTE phase.
- analyzed count
- 160
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05388669-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-rybrevant-b2022b2b
- nct id
- NCT05388669
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion
- regimen
- Participants were administered lazertinib 240 mg orally once daily from Cycle 1 Day 1 until Cycle 15, with each cycle consisting of 28 days. Participants then received amivantamab intravenous infusion at dose 1050 mg (if BW\< 80 kg) or 1400 mg (if BW \>=80 kg) on Cycle 1 Days 1-2 (split dose), 8, 15, 22, and on Days 1 and 15 of each subsequent cycle, starting from Cycle 2. After the completion of primary analysis, participants who benefited from the study treatment continued their treatment within the study upon transitioning into the LTE phase.
- analyzed count
- 142
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05388669-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-rybrevant-b2022b2b
- nct id
- NCT05388669
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm A: Lazertinib With Amivantamab SC-CF
- regimen
- Participants were administered lazertinib 240 milligrams (mg) tablet orally once daily from Cycle 1 Day 1 until Cycle 15, with each cycle consisting of 28 days. Participants then received amivantamab subcutaneous injection with at dose 1600 mg (if body weight \[BW\] is less than \[\<\] 80 kilograms \[kg\]) or 2240 mg (if BW is greater than or equal to \[\>=\] 80 kg) co-formulated (SC-CF) with recombinant human hyaluronidase PH20 (rHuPH20) 160 milligrams per milliliter (mg/mL) through manual injection on Cycle 1 Days 1, 8, 15, and 22, and on Days 1 and 15 of each subsequent cycle, starting from Cycle 2. After the completion of primary analysis, participants who benefited from the study treatment continued their treatment within the study upon transitioning into the LTE phase.
- analyzed count
- 140
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05388669-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-rybrevant-b2022b2b
- nct id
- NCT05388669
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion
- regimen
- Participants were administered lazertinib 240 mg orally once daily from Cycle 1 Day 1 until Cycle 15, with each cycle consisting of 28 days. Participants then received amivantamab intravenous infusion at dose 1050 mg (if BW\< 80 kg) or 1400 mg (if BW \>=80 kg) on Cycle 1 Days 1-2 (split dose), 8, 15, 22, and on Days 1 and 15 of each subsequent cycle, starting from Cycle 2. After the completion of primary analysis, participants who benefited from the study treatment continued their treatment within the study upon transitioning into the LTE phase.
- analyzed count
- 132
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05388669-om-0002#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-rybrevant-b2022b2b
- nct id
- NCT05388669
- harm key
- EG000
- source section id
- NCT05388669-ae
- event group key
- EG000
- event group label
- Arm A: Lazertinib With Amivantamab SC-CF
- serious affected
- 59
- serious at risk
- 206
- other affected
- 201
- other at risk
- 206
- frequency threshold
- 5
- collection period
- All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
- event definition
- Safety analysis set included all randomized participants who received at least 1 dose of study drug.
- 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-b2022b2b
- nct id
- NCT05388669
- harm key
- EG001
- source section id
- NCT05388669-ae
- event group key
- EG001
- event group label
- Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion
- serious affected
- 64
- serious at risk
- 210
- other affected
- 207
- other at risk
- 210
- frequency threshold
- 5
- collection period
- All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
- event definition
- Safety analysis set included all randomized participants who received at least 1 dose of study drug.
- 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
- setting source links
Preserved source evidence · Not medical advice