TriangleNCT02367781 · OUTCOME
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Perecentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Up to approximately 35 months after first subject enrolled
What was measured
Baseline prevalence and post-baseline incidence of anti-drug antibodies (ADA) to Atezolizumab in the Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) and Arm B Carboplatin+nab-paclitaxel Crossover Participants
Analysis population: The baseline ADA-evaluable population included participants who had a baseline ADA result. The post-baseline ADA-evaluable population included participants who had at least one post-baseline ADA result and who had received at least one dose of study treatment. The ADA-evaluable WT population was defined as the ADA-evaluable population excluding participants with an activating EGFR mutation or ALK translocation.
Groups in this outcome
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Arm B (Nab-Paclitaxel+Carboplatin)
Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
| Group | Source count |
|---|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 473 |
| Arm B (Nab-Paclitaxel+Carboplatin) | 96 |
Reported measurements
Baseline
| Group | Source count |
|---|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 473 |
| Arm B (Nab-Paclitaxel+Carboplatin) | 84 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 3.1 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Nab-Paclitaxel+Carboplatin) | 4.8 | Not reported | Not reported | Not reported | Not reported |
Post-baseline
| Group | Source count |
|---|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 446 |
| Arm B (Nab-Paclitaxel+Carboplatin) | 96 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 22.4 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Nab-Paclitaxel+Carboplatin) | 23.5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3.1
- group Id
- OG001
- value
- 4.8
- denoms
- counts
- group Id
- OG000
- value
- 473
- group Id
- OG001
- value
- 84
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- value
- 22.4
- group Id
- OG001
- value
- 23.5
- denoms
- counts
- group Id
- OG000
- value
- 446
- group Id
- OG001
- value
- 96
- units
- Participants
- title
- Post-baseline
- denoms
- counts
- group Id
- OG000
- value
- 473
- group Id
- OG001
- value
- 96
- units
- Participants
- description
- Baseline prevalence and post-baseline incidence of anti-drug antibodies (ADA) to Atezolizumab in the Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) and Arm B Carboplatin+nab-paclitaxel Crossover Participants
- groups
- description
- Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
- id
- OG000
- title
- Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
- description
- Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
- id
- OG001
- title
- Arm B (Nab-Paclitaxel+Carboplatin)
- param Type
- NUMBER
- population Description
- The baseline ADA-evaluable population included participants who had a baseline ADA result. The post-baseline ADA-evaluable population included participants who had at least one post-baseline ADA result and who had received at least one dose of study treatment. The ADA-evaluable WT population was defined as the ADA-evaluable population excluding participants with an activating EGFR mutation or ALK translocation.
- reporting Status
- POSTED
- time Frame
- Up to approximately 35 months after first subject enrolled
- title
- Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
- type
- SECONDARY
- unit Of Measure
- Perecentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice