TriangleNCT02888743 · OUTCOME
Local Control Rate and Abscopal Response Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 2 years
What was measured
NSCLC: Local control - Having two or more scans with RECIST response of stable disease (SD), one response of SD followed by non-confirmed PR, or a confirmed response of PR. Abscopal response occurs when a local therapy, such as radiation therapy, not only shrinks the targeted tumor(s) but also leads to the shrinkage of untreated tumors elsewhere in the body. Abscopal response is measured using RECIST criteria (proportion of patients with complete (CR) or partial (PR) response to therapy).
Analysis population: Participants receiving at least one regimen of protocol therapy.
Groups in this outcome
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
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
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
| Group | Source count |
|---|---|
| Arm A (Tremelimumab, Durvalumab, HD-RT) | 26 |
| Arm B (Tremelimumab, Durvalumab, LD-RT) | 26 |
| Arm C (Tremelimumab, Durvalumab) | 26 |
Reported measurements
Local control
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Tremelimumab, Durvalumab, HD-RT) | 9 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Tremelimumab, Durvalumab, LD-RT) | 6 | Not reported | Not reported | Not reported | Not reported |
| Arm C (Tremelimumab, Durvalumab) | 8 | Not reported | Not reported | Not reported | Not reported |
Abscopal response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Tremelimumab, Durvalumab, HD-RT) | 3 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Tremelimumab, Durvalumab, LD-RT) | 2 | Not reported | Not reported | Not reported | Not reported |
| Arm C (Tremelimumab, Durvalumab) | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 8
- title
- Local control
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- title
- Abscopal response
- denoms
- counts
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 26
- group Id
- OG002
- value
- 26
- units
- Participants
- description
- NSCLC: Local control - Having two or more scans with RECIST response of stable disease (SD), one response of SD followed by non-confirmed PR, or a confirmed response of PR. Abscopal response occurs when a local therapy, such as radiation therapy, not only shrinks the targeted tumor(s) but also leads to the shrinkage of untreated tumors elsewhere in the body. Abscopal response is measured using RECIST criteria (proportion of patients with complete (CR) or partial (PR) response to therapy).
- 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
- 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
- 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
- Arm C (Tremelimumab, Durvalumab)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Participants receiving at least one regimen of protocol therapy.
- reporting Status
- POSTED
- time Frame
- Up to 2 years
- title
- Local Control Rate and Abscopal Response Rate
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice