NCT03456076 · OUTCOME
Plasma Concentration of Alectinib
A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer · Source last updated 2026-07-15
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Predose (2 hours) Week 3 - Week 96
Analysis population: The PK-evaluable population consisted of all participants who received at least one dose of alectinib and who had at least one post-baseline PK sample available. This population did not include participants from the platinum-based chemotherapy arm, who did not receive alectinib.
Groups in this outcome
Alectinib
Participants received 600 mg oral alectinib twice daily (BID) for 2 years
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 |
|---|
| Alectinib | 124 |
|---|
Reported measurements
Week 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Alectinib | 118 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Alectinib | 382 | 276.2 | Not reported | Not reported | Not reported |
|---|
Week 6
Analysis denominator · Participants
| Group | Source count |
|---|
| Alectinib | 116 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Alectinib | 611 | 70.6 | Not reported | Not reported | Not reported |
|---|
Week 9
Analysis denominator · Participants
| Group | Source count |
|---|
| Alectinib | 114 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Alectinib | 593 | 91.4 | Not reported | Not reported | Not reported |
|---|
Week 12
Analysis denominator · Participants
| Group | Source count |
|---|
| Alectinib | 113 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Alectinib | 581 | 94.9 | Not reported | Not reported | Not reported |
|---|
Week 24
Analysis denominator · Participants
| Group | Source count |
|---|
| Alectinib | 111 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Alectinib | 619 | 93.2 | Not reported | Not reported | Not reported |
|---|
Week 36
Analysis denominator · Participants
| Group | Source count |
|---|
| Alectinib | 107 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Alectinib | 639 | 54.1 | Not reported | Not reported | Not reported |
|---|
Week 48
Analysis denominator · Participants
| Group | Source count |
|---|
| Alectinib | 103 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Alectinib | 551 | 90.1 | Not reported | Not reported | Not reported |
|---|
Week 60
Analysis denominator · Participants
| Group | Source count |
|---|
| Alectinib | 102 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Alectinib | 588 | 58.9 | Not reported | Not reported | Not reported |
|---|
Week 72
Analysis denominator · Participants
| Group | Source count |
|---|
| Alectinib | 97 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Alectinib | 527 | 96.5 | Not reported | Not reported | Not reported |
|---|
Week 84
Analysis denominator · Participants
| Group | Source count |
|---|
| Alectinib | 81 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Alectinib | 515 | 91.1 | Not reported | Not reported | Not reported |
|---|
Week 96
Analysis denominator · Participants
| Group | Source count |
|---|
| Alectinib | 68 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Alectinib | 478 | 106.4 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 276.2
- value
- 382
- title
- Week 3
- categories
- measurements
- group Id
- OG000
- spread
- 70.6
- value
- 611
- title
- Week 6
- categories
- measurements
- group Id
- OG000
- spread
- 91.4
- value
- 593
- title
- Week 9
- categories
- measurements
- group Id
- OG000
- spread
- 94.9
- value
- 581
- title
- Week 12
- categories
- measurements
- group Id
- OG000
- spread
- 93.2
- value
- 619
- title
- Week 24
- categories
- measurements
- group Id
- OG000
- spread
- 54.1
- value
- 639
- title
- Week 36
- categories
- measurements
- group Id
- OG000
- spread
- 90.1
- value
- 551
- title
- Week 48
- categories
- measurements
- group Id
- OG000
- spread
- 58.9
- value
- 588
- title
- Week 60
- categories
- measurements
- group Id
- OG000
- spread
- 96.5
- value
- 527
- title
- Week 72
- categories
- measurements
- group Id
- OG000
- spread
- 91.1
- value
- 515
- title
- Week 84
- categories
- measurements
- group Id
- OG000
- spread
- 106.4
- value
- 478
- title
- Week 96
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received 600 mg oral alectinib twice daily (BID) for 2 years
- id
- OG000
- title
- Alectinib
- param Type
- GEOMETRIC_MEAN
- population Description
- The PK-evaluable population consisted of all participants who received at least one dose of alectinib and who had at least one post-baseline PK sample available. This population did not include participants from the platinum-based chemotherapy arm, who did not receive alectinib.
- reporting Status
- POSTED
- time Frame
- Predose (2 hours) Week 3 - Week 96
- title
- Plasma Concentration of Alectinib
- type
- SECONDARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice