TriangleNCT01154140 · OUTCOME
Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by IRR
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
- 95% Confidence Interval
- Time frame
- Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
What was measured
ORR was defined as percentage of participants with complete response (CR) or partial response (PR) according to RECIST v1.1 determined by IRR. CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as greater than or equal to (\>=) 30% decrease taking as reference the baseline sum of lesion dimensions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No clear progression of non-target disease. No new lesions.
Analysis population: The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.
Groups in this outcome
Crizotinib
Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
Chemotherapy
Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)\^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m\^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg\*min/mL, approximately 30 min after end of pemetrexed infusion.
| Group | Source count |
|---|---|
| Crizotinib | 172 |
| Chemotherapy | 171 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Crizotinib | 74.4 | Not reported | 67.2 | 80.8 | Not reported |
| Chemotherapy | 45.0 | Not reported | 37.4 | 52.8 | Not reported |
Source statistical analyses
- ci Lower Limit
- 19.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 39.3
- estimate Comment
- 95% CI was calculated based on normal distribution.
- group Description
- If the PFS endpoint was significant, ORR was to be considered significant if the 2-sided p-value from Pearson chi-square test was (less than or equal to)\<= 0.0494.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- p Value Comment
- P-value was obtained from a Pearson chi-square test.
- param Type
- Difference in Percentage
- param Value
- 29.4
- statistical Method
- Pearson chi-square test
Complete source fields
- analyses
- ci Lower Limit
- 19.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 39.3
- estimate Comment
- 95% CI was calculated based on normal distribution.
- group Description
- If the PFS endpoint was significant, ORR was to be considered significant if the 2-sided p-value from Pearson chi-square test was (less than or equal to)\<= 0.0494.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- p Value Comment
- P-value was obtained from a Pearson chi-square test.
- param Type
- Difference in Percentage
- param Value
- 29.4
- statistical Method
- Pearson chi-square test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 67.2
- upper Limit
- 80.8
- value
- 74.4
- group Id
- OG001
- lower Limit
- 37.4
- upper Limit
- 52.8
- value
- 45.0
- denoms
- counts
- group Id
- OG000
- value
- 172
- group Id
- OG001
- value
- 171
- units
- Participants
- description
- ORR was defined as percentage of participants with complete response (CR) or partial response (PR) according to RECIST v1.1 determined by IRR. CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as greater than or equal to (\>=) 30% decrease taking as reference the baseline sum of lesion dimensions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No clear progression of non-target disease. No new lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
- id
- OG000
- title
- Crizotinib
- description
- Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)\^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m\^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg\*min/mL, approximately 30 min after end of pemetrexed infusion.
- id
- OG001
- title
- Chemotherapy
- param Type
- NUMBER
- population Description
- The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.
- reporting Status
- POSTED
- time Frame
- Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
- title
- Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by IRR
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice