TriangleNCT02888743 · OUTCOME
Progression-free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- From date of randomization until objective disease progression or death, whichever occurs first [up to 2 years]
What was measured
Distributions are summarized using the Kaplan-Meier method. Median times for each therapy arm are accompanied by 90% confidence intervals based on log(-log(endpoint)) methodology. NSCLC: The pairwise comparisons between the durvalumab/tremelimumab alone and durvalumab/tremelimumab with RT arms will be conducted using Cox regression. CRC: No statistical comparisons conducted between Arms A and B.
Analysis population: Patients receiving at least one regimen of protocol therapy.
Groups in this outcome
NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT)
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive high-dose radiation therapy QD over 10 days for up to 3 fractions. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT)
Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive low-dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
NSCLC Arm C (Tremelimumab, Durvalumab)
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Durvalumab: Given IV Tremelimumab: Given IV
CRC Arm A (Tremelimumab, Durvalumab, HD-RT)
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive high-dose radiation therapy QD over 10 days for up to 3 fractions. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
CRC Arm B (Tremelimumab, Durvalumab, LD-RT)
Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive low-dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
| Group | Source count |
|---|---|
| NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT) | 26 |
| NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT) | 26 |
| NSCLC Arm C (Tremelimumab, Durvalumab) | 26 |
| CRC Arm A (Tremelimumab, Durvalumab, HD-RT) | 10 |
| CRC Arm B (Tremelimumab, Durvalumab, LD-RT) | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT) | 4.0 | Not reported | 2.1 | 7.0 | Not reported |
| NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT) | 4.6 | Not reported | 2.1 | 7.2 | Not reported |
| NSCLC Arm C (Tremelimumab, Durvalumab) | 3.3 | Not reported | 1.8 | 5.5 | Not reported |
| CRC Arm A (Tremelimumab, Durvalumab, HD-RT) | 1.8 | Not reported | 1.5 | 2.0 | Not reported |
| CRC Arm B (Tremelimumab, Durvalumab, LD-RT) | 1.6 | Not reported | 1.3 | 1.9 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.60
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 1.58
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.92
- param Type
- Hazard Ratio (HR)
- param Value
- 0.81
- statistical Method
- Regression, Cox
- ci Lower Limit
- 0.50
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 1.38
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.55
- param Type
- Hazard Ratio (HR)
- param Value
- 0.83
- statistical Method
- Regression, Cox
Complete source fields
- analyses
- ci Lower Limit
- 0.60
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 1.58
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.92
- param Type
- Hazard Ratio (HR)
- param Value
- 0.81
- statistical Method
- Regression, Cox
- ci Lower Limit
- 0.50
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 1.38
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.55
- param Type
- Hazard Ratio (HR)
- param Value
- 0.83
- statistical Method
- Regression, Cox
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.1
- upper Limit
- 7.0
- value
- 4.0
- group Id
- OG001
- lower Limit
- 2.1
- upper Limit
- 7.2
- value
- 4.6
- group Id
- OG002
- lower Limit
- 1.8
- upper Limit
- 5.5
- value
- 3.3
- group Id
- OG003
- lower Limit
- 1.5
- upper Limit
- 2.0
- value
- 1.8
- group Id
- OG004
- lower Limit
- 1.3
- upper Limit
- 1.9
- value
- 1.6
- denoms
- counts
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 26
- group Id
- OG002
- value
- 26
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 9
- units
- Participants
- description
- Distributions are summarized using the Kaplan-Meier method. Median times for each therapy arm are accompanied by 90% confidence intervals based on log(-log(endpoint)) methodology. NSCLC: The pairwise comparisons between the durvalumab/tremelimumab alone and durvalumab/tremelimumab with RT arms will be conducted using Cox regression. CRC: No statistical comparisons conducted between Arms A and B.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive high-dose radiation therapy QD over 10 days for up to 3 fractions. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
- id
- OG000
- title
- NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT)
- description
- Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive low-dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
- id
- OG001
- title
- NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT)
- description
- Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Durvalumab: Given IV Tremelimumab: Given IV
- id
- OG002
- title
- NSCLC Arm C (Tremelimumab, Durvalumab)
- description
- Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive high-dose radiation therapy QD over 10 days for up to 3 fractions. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
- id
- OG003
- title
- CRC Arm A (Tremelimumab, Durvalumab, HD-RT)
- description
- Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive low-dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
- id
- OG004
- title
- CRC Arm B (Tremelimumab, Durvalumab, LD-RT)
- param Type
- MEDIAN
- population Description
- Patients receiving at least one regimen of protocol therapy.
- reporting Status
- POSTED
- time Frame
- From date of randomization until objective disease progression or death, whichever occurs first [up to 2 years]
- title
- Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice