TriangleNCT03066778 · OUTCOME
Time to True Deterioration (TTD) in the Composite Endpoint of Cough, Chest Pain, and Dyspnea Using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) and Lung Cancer Module 13 (QLQ-LC13)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Day 1 of Cycles 1-9, Day 1 of every other cycle for Cycles 10-17 and 30 days after last dose of study treatment (Up to approximately 27 months)
What was measured
TTD in patient-reported lung cancer symptoms of cough (QLQ-LC-13 Item 1), chest pain (QLQ-LC-13 Item 10), and dyspnea (QLQ-C30 Item 8) was a composite endpoint defined as the time to first onset of ≥10 point deterioration from baseline in an item confirmed by a second adjacent ≥10 point deterioration. The QLQ-LC13 consists of 13 measures of lung cancer symptoms and side effects from chemotherapy and radiation. It is scored on a 4-point scale (1=none, 2=a little, 3=quite a bit, 4=very much). Scores were transformed to a range of 0 to 100 using a standard algorithm. Higher scores represented increasing symptom severity. TTD was calculated using the product-limit Kaplan-Meier method for censored data and is presented for the first course of study treatment per protocol.
Analysis population: All participants who received at least 1 dose of study medication and had non-missing assessments.
Groups in this outcome
Pembrolizumab+EP
During each 21-day cycle, participants received pembrolizumab 200 mg intravenously (IV) on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an area under the plasma drug concentration-time curve \[AUC\] 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1). Participants who stopped pembrolizumab as a result of obtaining a response of stable disease (SD), partial response (PR), complete response (CR) or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for retreatment.
Placebo+EP
During each 21-day cycle, participants received placebo (normal saline solution) IV on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an AUC 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1).
| Group | Source count |
|---|---|
| Pembrolizumab+EP | 221 |
| Placebo+EP | 218 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab+EP | NA | Not reported | NA | NA | Median TTD and lower and upper limits not reached (no protocol-specified deterioration criteria reached by time of last assessment) |
| Placebo+EP | 8.7 | Not reported | 5.9 | NA | TTD upper limit not reached (no protocol-specified deterioration criteria reached by time of last assessment) |
Source statistical analyses
- ci Lower Limit
- 0.56
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.14
- estimate Comment
- Based on Cox regression model with treatment as a covariate stratified by platinum chemotherapy ECOG, and LDH. Cisplatin, ECOG 0, LDH ≤ULN and Cisplatin, ECOG 0, LDH \>ULN were combined into one stratum because of small sample size
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.208
- param Type
- Hazard Ratio (HR)
- param Value
- 0.80
- statistical Comment
- Two-sided p-value based on stratified log-rank test
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.56
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.14
- estimate Comment
- Based on Cox regression model with treatment as a covariate stratified by platinum chemotherapy ECOG, and LDH. Cisplatin, ECOG 0, LDH ≤ULN and Cisplatin, ECOG 0, LDH \>ULN were combined into one stratum because of small sample size
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.208
- param Type
- Hazard Ratio (HR)
- param Value
- 0.80
- statistical Comment
- Two-sided p-value based on stratified log-rank test
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Median TTD and lower and upper limits not reached (no protocol-specified deterioration criteria reached by time of last assessment)
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- TTD upper limit not reached (no protocol-specified deterioration criteria reached by time of last assessment)
- group Id
- OG001
- lower Limit
- 5.9
- upper Limit
- NA
- value
- 8.7
- denoms
- counts
- group Id
- OG000
- value
- 221
- group Id
- OG001
- value
- 218
- units
- Participants
- description
- TTD in patient-reported lung cancer symptoms of cough (QLQ-LC-13 Item 1), chest pain (QLQ-LC-13 Item 10), and dyspnea (QLQ-C30 Item 8) was a composite endpoint defined as the time to first onset of ≥10 point deterioration from baseline in an item confirmed by a second adjacent ≥10 point deterioration. The QLQ-LC13 consists of 13 measures of lung cancer symptoms and side effects from chemotherapy and radiation. It is scored on a 4-point scale (1=none, 2=a little, 3=quite a bit, 4=very much). Scores were transformed to a range of 0 to 100 using a standard algorithm. Higher scores represented increasing symptom severity. TTD was calculated using the product-limit Kaplan-Meier method for censored data and is presented for the first course of study treatment per protocol.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- During each 21-day cycle, participants received pembrolizumab 200 mg intravenously (IV) on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an area under the plasma drug concentration-time curve \[AUC\] 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1). Participants who stopped pembrolizumab as a result of obtaining a response of stable disease (SD), partial response (PR), complete response (CR) or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for retreatment.
- id
- OG000
- title
- Pembrolizumab+EP
- description
- During each 21-day cycle, participants received placebo (normal saline solution) IV on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an AUC 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1).
- id
- OG001
- title
- Placebo+EP
- param Type
- MEDIAN
- population Description
- All participants who received at least 1 dose of study medication and had non-missing assessments.
- reporting Status
- POSTED
- time Frame
- Day 1 of Cycles 1-9, Day 1 of every other cycle for Cycles 10-17 and 30 days after last dose of study treatment (Up to approximately 27 months)
- title
- Time to True Deterioration (TTD) in the Composite Endpoint of Cough, Chest Pain, and Dyspnea Using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) and Lung Cancer Module 13 (QLQ-LC13)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice