TriangleNCT02409342 · OUTCOME
Percentage of Participants With Objective Response (ORR) in the TC3 or IC3-WT Populations
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Every 6 weeks for 48 weeks following Day 1, thereafter every 9 weeks after completion of Week 48 tumor assessment, regardless of treatment delays, until radiographic disease progression until data cut-off on 10 Sep 2018 (up to approximately 38 months)
What was measured
Objective response (partial response plus complete response) as determined by the investigator according to RECIST v1.1.
Analysis population: Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]).
Groups in this outcome
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
Atezolizumab
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
| Group | Source count |
|---|---|
| Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine) | 98 |
| Atezolizumab | 107 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine) | 28.6 | Not reported | Not reported | Not reported | Not reported |
| Atezolizumab | 38.3 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -4.07
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 23.56
- group Description
- TC3 or IC3-WT Population
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified Analysis
- non Inferiority Type
- SUPERIORITY
- param Type
- Difference in ORR
- param Value
- 9.75
Complete source fields
- analyses
- ci Lower Limit
- -4.07
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 23.56
- group Description
- TC3 or IC3-WT Population
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified Analysis
- non Inferiority Type
- SUPERIORITY
- param Type
- Difference in ORR
- param Value
- 9.75
- classes
- categories
- measurements
- group Id
- OG000
- value
- 28.6
- group Id
- OG001
- value
- 38.3
- denoms
- counts
- group Id
- OG000
- value
- 98
- group Id
- OG001
- value
- 107
- units
- Participants
- description
- Objective response (partial response plus complete response) as determined by the investigator according to RECIST v1.1.
- groups
- description
- Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
- id
- OG000
- title
- Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
- description
- Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
- id
- OG001
- title
- Atezolizumab
- param Type
- NUMBER
- population Description
- Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]).
- reporting Status
- POSTED
- time Frame
- Every 6 weeks for 48 weeks following Day 1, thereafter every 9 weeks after completion of Week 48 tumor assessment, regardless of treatment delays, until radiographic disease progression until data cut-off on 10 Sep 2018 (up to approximately 38 months)
- title
- Percentage of Participants With Objective Response (ORR) in the TC3 or IC3-WT Populations
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice