NCT04685135 · OUTCOME
Plasma Concentration of Adagrasib
Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation · Source last updated 2026-08-11
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- nanogram per milliliter (ng/mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Day 1 of Cycle 1 (Pre-Dose and Peak), Cycle 2 (Pre-Dose and Peak), Cycle 3 (Pre-Dose), Cycle 5 (Pre-Dose), Cycle 7 (Pre-Dose) (Each cycle is of 21 days)
What was measured
Blood samples were collected for assessment of plasma concentration of Adagrasib. Data for participants for which the dose was reduced after receiving starting dose of 600 mg BID, based on physician decision is presented in separate arms.
Analysis population: The PK evaluable population is defined as patients who received at least one dose of active study drug and had at least one blood sample collected to assess PK concentrations
Groups in this outcome
Adagrasib 200 mg BID
Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered with study treatment in 3-week cycle and were administered 200 mg BID Adagrasib orally.
Adagrasib 400 mg QD
Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered with study treatment in 3-week cycle and were administered 400 mg QD Adagrasib orally.
Adagrasib 400 mg BID
Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered with study treatment in 3-week cycle and were administered 400 mg BID Adagrasib orally.
Adagrasib 600 mg QD
Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered with study treatment in 3-week cycle and were administered 600 mg QD Adagrasib orally.
Adagrasib 600 mg BID
Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered with study treatment in 3-week cycle and were administered 600 mg BID Adagrasib orally.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Adagrasib 200 mg BID | 1 |
|---|
| Adagrasib 400 mg QD | 2 |
|---|
| Adagrasib 400 mg BID | 48 |
|---|
| Adagrasib 600 mg QD | 15 |
|---|
| Adagrasib 600 mg BID | 295 |
|---|
Reported measurements
Cycle 1 Day 1 Pre-Dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Adagrasib 200 mg BID | 1 |
|---|
| Adagrasib 400 mg QD | 0 |
|---|
| Adagrasib 400 mg BID | 2 |
|---|
| Adagrasib 600 mg QD | 15 |
|---|
| Adagrasib 600 mg BID | 295 |
|---|
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Adagrasib 200 mg BID | NA | NA | Not reported | Not reported | Concentrations that are below the limit of quantification (BLQ) are treated as NA |
|---|
| Adagrasib 400 mg BID | NA | NA | Not reported | Not reported | Concentrations that are below the limit of quantification (BLQ) are treated as NA |
|---|
| Adagrasib 600 mg QD | NA | NA | Not reported | Not reported | Concentrations that are below the limit of quantification (BLQ) are treated as NA |
|---|
| Adagrasib 600 mg BID | NA | NA | Not reported | Not reported | Concentrations that are below the limit of quantification (BLQ) are treated as NA |
|---|
Cycle 1 Day 1 Peak
Analysis denominator · Participants
| Group | Source count |
|---|
| Adagrasib 200 mg BID | 1 |
|---|
| Adagrasib 400 mg QD | 0 |
|---|
| Adagrasib 400 mg BID | 2 |
|---|
| Adagrasib 600 mg QD | 15 |
|---|
| Adagrasib 600 mg BID | 280 |
|---|
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Adagrasib 200 mg BID | NA | NA | Not reported | Not reported | Concentrations that are below the limit of quantification (BLQ) are treated as NA |
|---|
| Adagrasib 400 mg BID | NA | NA | Not reported | Not reported | Concentrations that are below the limit of quantification (BLQ) are treated as NA |
|---|
| Adagrasib 600 mg QD | 556.963 | 63.550 | Not reported | Not reported | Not reported |
|---|
| Adagrasib 600 mg BID | 518.944 | 86.625 | Not reported | Not reported | Not reported |
|---|
Cycle 2 Day 1 Pre-Dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Adagrasib 200 mg BID | 1 |
|---|
| Adagrasib 400 mg QD | 0 |
|---|
| Adagrasib 400 mg BID | 12 |
|---|
| Adagrasib 600 mg QD | 2 |
|---|
| Adagrasib 600 mg BID | 194 |
|---|
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Adagrasib 200 mg BID | NA | NA | Not reported | Not reported | Concentrations that are below the limit of quantification (BLQ) are treated as NA |
|---|
| Adagrasib 400 mg BID | 1579.040 | 54.432 | Not reported | Not reported | Not reported |
|---|
| Adagrasib 600 mg QD | NA | NA | Not reported | Not reported | Concentrations that are below the limit of quantification (BLQ) are treated as NA |
|---|
| Adagrasib 600 mg BID | 2097.813 | 67.912 | Not reported | Not reported | Not reported |
|---|
Cycle 2 Day 1 Peak
Analysis denominator · Participants
| Group | Source count |
|---|
| Adagrasib 200 mg BID | 0 |
|---|
| Adagrasib 400 mg QD | 2 |
|---|
| Adagrasib 400 mg BID | 15 |
|---|
| Adagrasib 600 mg QD | 13 |
|---|
| Adagrasib 600 mg BID | 175 |
|---|
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Adagrasib 400 mg QD | NA | NA | Not reported | Not reported | Concentrations that are below the limit of quantification (BLQ) are treated as NA |
|---|
| Adagrasib 400 mg BID | 2011.347 | 39.333 | Not reported | Not reported | Not reported |
|---|
| Adagrasib 600 mg QD | 2331.298 | 59.515 | Not reported | Not reported | Not reported |
|---|
| Adagrasib 600 mg BID | 2117.333 | 62.744 | Not reported | Not reported | Not reported |
|---|
Cycle 3 Day 1 Pre-Dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Adagrasib 200 mg BID | 0 |
|---|
| Adagrasib 400 mg QD | 0 |
|---|
| Adagrasib 400 mg BID | 45 |
|---|
| Adagrasib 600 mg QD | 1 |
|---|
| Adagrasib 600 mg BID | 130 |
|---|
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Adagrasib 400 mg BID | NA | NA | Not reported | Not reported | Concentrations that are below the limit of quantification (BLQ) are treated as NA |
|---|
| Adagrasib 600 mg QD | NA | NA | Not reported | Not reported | Concentrations that are below the limit of quantification (BLQ) are treated as NA |
|---|
| Adagrasib 600 mg BID | 1865.408 | 42.930 | Not reported | Not reported | Not reported |
|---|
Cycle 5 Day 1 Pre-Dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Adagrasib 200 mg BID | 0 |
|---|
| Adagrasib 400 mg QD | 0 |
|---|
| Adagrasib 400 mg BID | 48 |
|---|
| Adagrasib 600 mg QD | 11 |
|---|
| Adagrasib 600 mg BID | 82 |
|---|
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Adagrasib 400 mg BID | 1114.046 | 39.300 | Not reported | Not reported | Not reported |
|---|
| Adagrasib 600 mg QD | 917.541 | 73.596 | Not reported | Not reported | Not reported |
|---|
| Adagrasib 600 mg BID | 1459.470 | 39.094 | Not reported | Not reported | Not reported |
|---|
Cycle 7 Day 1 Pre-Dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Adagrasib 200 mg BID | 0 |
|---|
| Adagrasib 400 mg QD | 2 |
|---|
| Adagrasib 400 mg BID | 35 |
|---|
| Adagrasib 600 mg QD | 7 |
|---|
| Adagrasib 600 mg BID | 54 |
|---|
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Adagrasib 400 mg QD | NA | NA | Not reported | Not reported | Concentrations that are below the limit of quantification (BLQ) are treated as NA |
|---|
| Adagrasib 400 mg BID | 1062.114 | 33.842 | Not reported | Not reported | Not reported |
|---|
| Adagrasib 600 mg QD | 863.539 | 42.917 | Not reported | Not reported | Not reported |
|---|
| Adagrasib 600 mg BID | 1548.018 | 41.166 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- comment
- Concentrations that are below the limit of quantification (BLQ) are treated as NA
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Concentrations that are below the limit of quantification (BLQ) are treated as NA
- group Id
- OG002
- spread
- NA
- value
- NA
- comment
- Concentrations that are below the limit of quantification (BLQ) are treated as NA
- group Id
- OG003
- spread
- NA
- value
- NA
- comment
- Concentrations that are below the limit of quantification (BLQ) are treated as NA
- group Id
- OG004
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 15
- group Id
- OG004
- value
- 295
- units
- Participants
- title
- Cycle 1 Day 1 Pre-Dose
- categories
- measurements
- comment
- Concentrations that are below the limit of quantification (BLQ) are treated as NA
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Concentrations that are below the limit of quantification (BLQ) are treated as NA
- group Id
- OG002
- spread
- NA
- value
- NA
- group Id
- OG003
- spread
- 63.550
- value
- 556.963
- group Id
- OG004
- spread
- 86.625
- value
- 518.944
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 15
- group Id
- OG004
- value
- 280
- units
- Participants
- title
- Cycle 1 Day 1 Peak
- categories
- measurements
- comment
- Concentrations that are below the limit of quantification (BLQ) are treated as NA
- group Id
- OG000
- spread
- NA
- value
- NA
- group Id
- OG002
- spread
- 54.432
- value
- 1579.040
- comment
- Concentrations that are below the limit of quantification (BLQ) are treated as NA
- group Id
- OG003
- spread
- NA
- value
- NA
- group Id
- OG004
- spread
- 67.912
- value
- 2097.813
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 194
- units
- Participants
- title
- Cycle 2 Day 1 Pre-Dose
- categories
- measurements
- comment
- Concentrations that are below the limit of quantification (BLQ) are treated as NA
- group Id
- OG001
- spread
- NA
- value
- NA
- group Id
- OG002
- spread
- 39.333
- value
- 2011.347
- group Id
- OG003
- spread
- 59.515
- value
- 2331.298
- group Id
- OG004
- spread
- 62.744
- value
- 2117.333
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 175
- units
- Participants
- title
- Cycle 2 Day 1 Peak
- categories
- measurements
- comment
- Concentrations that are below the limit of quantification (BLQ) are treated as NA
- group Id
- OG002
- spread
- NA
- value
- NA
- comment
- Concentrations that are below the limit of quantification (BLQ) are treated as NA
- group Id
- OG003
- spread
- NA
- value
- NA
- group Id
- OG004
- spread
- 42.930
- value
- 1865.408
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 45
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 130
- units
- Participants
- title
- Cycle 3 Day 1 Pre-Dose
- categories
- measurements
- group Id
- OG002
- spread
- 39.300
- value
- 1114.046
- group Id
- OG003
- spread
- 73.596
- value
- 917.541
- group Id
- OG004
- spread
- 39.094
- value
- 1459.470
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 48
- group Id
- OG003
- value
- 11
- group Id
- OG004
- value
- 82
- units
- Participants
- title
- Cycle 5 Day 1 Pre-Dose
- categories
- measurements
- comment
- Concentrations that are below the limit of quantification (BLQ) are treated as NA
- group Id
- OG001
- spread
- NA
- value
- NA
- group Id
- OG002
- spread
- 33.842
- value
- 1062.114
- group Id
- OG003
- spread
- 42.917
- value
- 863.539
- group Id
- OG004
- spread
- 41.166
- value
- 1548.018
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 35
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 54
- units
- Participants
- title
- Cycle 7 Day 1 Pre-Dose
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 48
- group Id
- OG003
- value
- 15
- group Id
- OG004
- value
- 295
- units
- Participants
- description
- Blood samples were collected for assessment of plasma concentration of Adagrasib. Data for participants for which the dose was reduced after receiving starting dose of 600 mg BID, based on physician decision is presented in separate arms.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered with study treatment in 3-week cycle and were administered 200 mg BID Adagrasib orally.
- id
- OG000
- title
- Adagrasib 200 mg BID
- description
- Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered with study treatment in 3-week cycle and were administered 400 mg QD Adagrasib orally.
- id
- OG001
- title
- Adagrasib 400 mg QD
- description
- Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered with study treatment in 3-week cycle and were administered 400 mg BID Adagrasib orally.
- id
- OG002
- title
- Adagrasib 400 mg BID
- description
- Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered with study treatment in 3-week cycle and were administered 600 mg QD Adagrasib orally.
- id
- OG003
- title
- Adagrasib 600 mg QD
- description
- Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered with study treatment in 3-week cycle and were administered 600 mg BID Adagrasib orally.
- id
- OG004
- title
- Adagrasib 600 mg BID
- param Type
- GEOMETRIC_MEAN
- population Description
- The PK evaluable population is defined as patients who received at least one dose of active study drug and had at least one blood sample collected to assess PK concentrations
- reporting Status
- POSTED
- time Frame
- Day 1 of Cycle 1 (Pre-Dose and Peak), Cycle 2 (Pre-Dose and Peak), Cycle 3 (Pre-Dose), Cycle 5 (Pre-Dose), Cycle 7 (Pre-Dose) (Each cycle is of 21 days)
- title
- Plasma Concentration of Adagrasib
- type
- SECONDARY
- unit Of Measure
- nanogram per milliliter (ng/mL)
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