NCT03735121 · OUTCOME
Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration
A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer · Source last updated 2025-12-05
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- μg/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cohort 1: Predose: D1 & postdose: D1, 3, 8 of C1; Cohort 2: Pre & postdose: D1 of C1, 3 & postdose: D3, 8 of C1, Predose: D1 of C2; Cohort 3: Pre & postdose: D1 of C1, 2 & postdose: D3, 8 of C1, D2, 4 & 9 of C2 & pre dose: D1 of C3
What was measured
Cycle length =21 days for cohorts 1 and 3 and 14 days for cohort 2. Day=D; Cycle=C.
Analysis population: PK-evaluable population included all participants who received at least one dose of atezolizumab and had at least 1 evaluable post dose PK sample that could affect PK results. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at a given timepoint.
Groups in this outcome
Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg
Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection on Cycle 1 Day 1 (1 cycle=21 days), followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 of subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg
Participants received atezolizumab, 1200 mg, co-mixed with rHuPH20, as SC injection, Q2W, on Day 1 of the first 3 cycles (Cycle 1-3=14 days), followed by atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg
Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection, Q3W, on Day 1 of first 3 cycles, followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 for subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
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 |
|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | 13 |
|---|
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | 15 |
|---|
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | 39 |
|---|
Reported measurements
Cycle 1, Day 1: Pre-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | 13 |
|---|
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | 15 |
|---|
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | 39 |
|---|
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | NA | NA | Not reported | Not reported | The data was not evaluable as all the samples were below lower limit of quantification (BLLQ). |
|---|
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | NA | NA | Not reported | Not reported | The data was not evaluable as all the samples were BLLQ. |
|---|
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | NA | NA | Not reported | Not reported | The data was not evaluable as all the samples were BLLQ. |
|---|
Cycle 1, Day 1: Post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | 13 |
|---|
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | 15 |
|---|
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | 39 |
|---|
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | 116 | 57.8 | Not reported | Not reported | Not reported |
|---|
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | 61.7 | 70.9 | Not reported | Not reported | Not reported |
|---|
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | 108 | 57.6 | Not reported | Not reported | Not reported |
|---|
Cycle 1, Day 3: Post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | 13 |
|---|
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | 15 |
|---|
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | 38 |
|---|
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | 247 | 40.5 | Not reported | Not reported | Not reported |
|---|
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | 123 | 44.3 | Not reported | Not reported | Not reported |
|---|
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | 166 | 45.7 | Not reported | Not reported | Not reported |
|---|
Cycle 1, Day 8: Post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | 13 |
|---|
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | 15 |
|---|
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | 37 |
|---|
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | 230 | 36.6 | Not reported | Not reported | Not reported |
|---|
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | 110 | 45.0 | Not reported | Not reported | Not reported |
|---|
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | 162 | 43.5 | Not reported | Not reported | Not reported |
|---|
Cycle 2, Day 1: Pre-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | 0 |
|---|
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | 15 |
|---|
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | 35 |
|---|
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | 77.5 | 51.4 | Not reported | Not reported | Not reported |
|---|
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | 78.3 | 88.6 | Not reported | Not reported | Not reported |
|---|
Cycle 2, Day 1: Post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | 0 |
|---|
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | 0 |
|---|
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | 36 |
|---|
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | 87.7 | 64.7 | Not reported | Not reported | Not reported |
|---|
Cycle 2, Day 2: Post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | 0 |
|---|
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | 0 |
|---|
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | 36 |
|---|
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | 183 | 46.1 | Not reported | Not reported | Not reported |
|---|
Cycle 2, Day 4: Post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | 0 |
|---|
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | 0 |
|---|
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | 34 |
|---|
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | 245 | 42.0 | Not reported | Not reported | Not reported |
|---|
Cycle 2, Day 9: Post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | 0 |
|---|
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | 0 |
|---|
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | 35 |
|---|
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | 225 | 37.2 | Not reported | Not reported | Not reported |
|---|
Cycle 3, Day 1: Pre-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | 0 |
|---|
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | 14 |
|---|
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | 33 |
|---|
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | 104 | 47.8 | Not reported | Not reported | Not reported |
|---|
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | 123 | 57.2 | Not reported | Not reported | Not reported |
|---|
Cycle 3, Day 1: Post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | 0 |
|---|
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | 1 |
|---|
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | 0 |
|---|
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | 189 | NA | Not reported | Not reported | Since only 1 participant was analysed the geometric coefficient of variation could not be calculated. |
|---|
Complete source fields
- classes
- categories
- measurements
- comment
- The data was not evaluable as all the samples were below lower limit of quantification (BLLQ).
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- The data was not evaluable as all the samples were BLLQ.
- group Id
- OG001
- spread
- NA
- value
- NA
- comment
- The data was not evaluable as all the samples were BLLQ.
- group Id
- OG002
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 39
- units
- Participants
- title
- Cycle 1, Day 1: Pre-dose
- categories
- measurements
- group Id
- OG000
- spread
- 57.8
- value
- 116
- group Id
- OG001
- spread
- 70.9
- value
- 61.7
- group Id
- OG002
- spread
- 57.6
- value
- 108
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 39
- units
- Participants
- title
- Cycle 1, Day 1: Post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 40.5
- value
- 247
- group Id
- OG001
- spread
- 44.3
- value
- 123
- group Id
- OG002
- spread
- 45.7
- value
- 166
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 38
- units
- Participants
- title
- Cycle 1, Day 3: Post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 36.6
- value
- 230
- group Id
- OG001
- spread
- 45.0
- value
- 110
- group Id
- OG002
- spread
- 43.5
- value
- 162
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 37
- units
- Participants
- title
- Cycle 1, Day 8: Post-dose
- categories
- measurements
- group Id
- OG001
- spread
- 51.4
- value
- 77.5
- group Id
- OG002
- spread
- 88.6
- value
- 78.3
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 35
- units
- Participants
- title
- Cycle 2, Day 1: Pre-dose
- categories
- measurements
- group Id
- OG002
- spread
- 64.7
- value
- 87.7
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 36
- units
- Participants
- title
- Cycle 2, Day 1: Post-dose
- categories
- measurements
- group Id
- OG002
- spread
- 46.1
- value
- 183
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 36
- units
- Participants
- title
- Cycle 2, Day 2: Post-dose
- categories
- measurements
- group Id
- OG002
- spread
- 42.0
- value
- 245
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 34
- units
- Participants
- title
- Cycle 2, Day 4: Post-dose
- categories
- measurements
- group Id
- OG002
- spread
- 37.2
- value
- 225
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 35
- units
- Participants
- title
- Cycle 2, Day 9: Post-dose
- categories
- measurements
- group Id
- OG001
- spread
- 47.8
- value
- 104
- group Id
- OG002
- spread
- 57.2
- value
- 123
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 33
- units
- Participants
- title
- Cycle 3, Day 1: Pre-dose
- categories
- measurements
- comment
- Since only 1 participant was analysed the geometric coefficient of variation could not be calculated.
- group Id
- OG001
- spread
- NA
- value
- 189
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- Cycle 3, Day 1: Post-dose
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 39
- units
- Participants
- description
- Cycle length =21 days for cohorts 1 and 3 and 14 days for cohort 2. Day=D; Cycle=C.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection on Cycle 1 Day 1 (1 cycle=21 days), followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 of subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
- id
- OG000
- title
- Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg
- description
- Participants received atezolizumab, 1200 mg, co-mixed with rHuPH20, as SC injection, Q2W, on Day 1 of the first 3 cycles (Cycle 1-3=14 days), followed by atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
- id
- OG001
- title
- Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg
- description
- Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection, Q3W, on Day 1 of first 3 cycles, followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 for subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
- id
- OG002
- title
- Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg
- param Type
- GEOMETRIC_MEAN
- population Description
- PK-evaluable population included all participants who received at least one dose of atezolizumab and had at least 1 evaluable post dose PK sample that could affect PK results. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at a given timepoint.
- reporting Status
- POSTED
- time Frame
- Cohort 1: Predose: D1 & postdose: D1, 3, 8 of C1; Cohort 2: Pre & postdose: D1 of C1, 3 & postdose: D3, 8 of C1, Predose: D1 of C2; Cohort 3: Pre & postdose: D1 of C1, 2 & postdose: D3, 8 of C1, D2, 4 & 9 of C2 & pre dose: D1 of C3
- title
- Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration
- type
- SECONDARY
- unit Of Measure
- μg/mL
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