TriangleNCT03043872 · OUTCOME
OS18 in the China Cohort
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- At 18 months post-randomization. Assessed at the China cohort second analysis DCO (02 November 2020).
What was measured
OS18 was defined as the percentage of patients who were alive at 18 months after randomization per the Kaplan-Meier estimate of OS at 18 months.
Analysis population: The China FAS included all randomized patients in the China cohort.
Groups in this outcome
China Cohort: D + T + EP
During Chemotherapy: Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Post-Chemotherapy: Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
China Cohort: D + EP
During Chemotherapy: Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Post-Chemotherapy: Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
China Cohort: EP
For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
| Group | Source count |
|---|---|
| China Cohort: D + T + EP | 65 |
| China Cohort: D + EP | 61 |
| China Cohort: EP | 62 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| China Cohort: D + T + EP | 40.0 | Not reported | 28.1 | 51.6 | Not reported |
| China Cohort: D + EP | 36.1 | Not reported | 24.3 | 48.0 | Not reported |
| China Cohort: EP | 23.4 | Not reported | 13.6 | 34.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 28.1
- upper Limit
- 51.6
- value
- 40.0
- group Id
- OG001
- lower Limit
- 24.3
- upper Limit
- 48.0
- value
- 36.1
- group Id
- OG002
- lower Limit
- 13.6
- upper Limit
- 34.6
- value
- 23.4
- denoms
- counts
- group Id
- OG000
- value
- 65
- group Id
- OG001
- value
- 61
- group Id
- OG002
- value
- 62
- units
- Participants
- description
- OS18 was defined as the percentage of patients who were alive at 18 months after randomization per the Kaplan-Meier estimate of OS at 18 months.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- During Chemotherapy: Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Post-Chemotherapy: Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
- id
- OG000
- title
- China Cohort: D + T + EP
- description
- During Chemotherapy: Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Post-Chemotherapy: Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
- id
- OG001
- title
- China Cohort: D + EP
- description
- For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
- id
- OG002
- title
- China Cohort: EP
- param Type
- NUMBER
- population Description
- The China FAS included all randomized patients in the China cohort.
- reporting Status
- POSTED
- time Frame
- At 18 months post-randomization. Assessed at the China cohort second analysis DCO (02 November 2020).
- title
- OS18 in the China Cohort
- type
- SECONDARY
- unit Of Measure
- percentage of patients
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice