TriangleNCT04487080 · OUTCOME
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization to either disease progression or death whichever occurs first (up to 32.8 months)
What was measured
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.
Analysis population: Full analysis set (FAS) included all randomized participants, classified according to their assigned treatment arm regardless of the actual treatment received.
Groups in this outcome
Experimental: Arm A (Open-label): Amivantamab + Lazertinib
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.
Active Comparator: Arm B (Double-blind): Osimertinib+Placebo Matching Lazertinib
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.
Experimental: Arm C (Double-blind): Lazertinib+Placebo Matching Osimertinib
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.
| Group | Source count |
|---|---|
| Experimental: Arm A (Open-label): Amivantamab + Lazertinib | 429 |
| Active Comparator: Arm B (Double-blind): Osimertinib+Placebo Matching Lazertinib | 429 |
| Experimental: Arm C (Double-blind): Lazertinib+Placebo Matching Osimertinib | 216 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Experimental: Arm A (Open-label): Amivantamab + Lazertinib | 23.72 | Not reported | 19.12 | 27.66 | Not reported |
| Active Comparator: Arm B (Double-blind): Osimertinib+Placebo Matching Lazertinib | 16.59 | Not reported | 14.78 | 18.46 | Not reported |
| Experimental: Arm C (Double-blind): Lazertinib+Placebo Matching Osimertinib | 18.46 | Not reported | 14.75 | 20.11 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.58
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.85
- estimate Comment
- HR and its 95% CI was estimated based on a stratified Cox's regression model with treatment as the sole explanatory variable.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0002
- param Type
- Hazard Ratio (HR)
- param Value
- 0.70
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.58
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.85
- estimate Comment
- HR and its 95% CI was estimated based on a stratified Cox's regression model with treatment as the sole explanatory variable.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0002
- param Type
- Hazard Ratio (HR)
- param Value
- 0.70
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 19.12
- upper Limit
- 27.66
- value
- 23.72
- group Id
- OG001
- lower Limit
- 14.78
- upper Limit
- 18.46
- value
- 16.59
- group Id
- OG002
- lower Limit
- 14.75
- upper Limit
- 20.11
- value
- 18.46
- denoms
- counts
- group Id
- OG000
- value
- 429
- group Id
- OG001
- value
- 429
- group Id
- OG002
- value
- 216
- units
- Participants
- description
- 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.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 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.
- id
- OG000
- title
- Experimental: Arm A (Open-label): Amivantamab + Lazertinib
- description
- 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.
- id
- OG001
- title
- Active Comparator: Arm B (Double-blind): Osimertinib+Placebo Matching Lazertinib
- description
- 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.
- id
- OG002
- title
- Experimental: Arm C (Double-blind): Lazertinib+Placebo Matching Osimertinib
- param Type
- MEDIAN
- population Description
- Full analysis set (FAS) included all randomized participants, classified according to their assigned treatment arm regardless of the actual treatment received.
- reporting Status
- POSTED
- time Frame
- From randomization to either disease progression or death whichever occurs first (up to 32.8 months)
- title
- Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice