NCT01970865 · OUTCOME
Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations · Source last updated 2024-08-12
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
- From start of study treatment to first documentation of PD or to death due to any cause, whichever occurred first (maximum of 8 years approximately)
What was measured
Duration of response(DOR): time from first documentation of objective tumor response (CR/PR) to first documentation of disease progression (PD) or to death due to any cause, whichever occurred first. DOR: calculated for subgroup of participants with confirmed objective tumor response. Intracranial DOR: calculated for participants with confirmed intracranial objective response. CR:disappearance of all non-lymph node target lesions (where all target lesions are recorded with length of 0mm on Target Lesion eCRF). Any pathological lymph node (recorded as target lesion) must have reduction in short axis to \<10mm. PR:30% or more decrease in SLD of target lesion, taking as reference baseline SLD. PD:20% or more increase in the SLD of target lesions relative to baseline or smallest SLD (nadir) recorded since first dose. In addition, also demonstrate absolute increase of at least 5mm (\>=5mm) relative to baseline or smallest SLD (nadir) recorded since first dose.
Analysis population: DOR analysis set included all ITT participants who had confirmed objective response; intracranial DOR analysis set included all ITT participants who had CNS metastases and achieved confirmed intracranial objective response. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data foe every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Groups in this outcome
ALK Positive Population (Phase 1)
This reporting arm includes all Phase 1 participants who had documented ALK rearrangement.
ROS1 Positive Population (Phase 1)
This reporting arm includes all Phase 1 participants who had documented ROS1 rearrangement.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| ALK Positive Population (Phase 1) | 16 |
|---|
| ROS1 Positive Population (Phase 1) | 6 |
|---|
Reported measurements
Participants with DOR
Analysis denominator · Participants
| Group | Source count |
|---|
| ALK Positive Population (Phase 1) | 10 |
|---|
| ROS1 Positive Population (Phase 1) | 4 |
|---|
<3 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
3 Months to <6 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
6 Months to <9 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
9 Months to <12 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
12 Months to <15 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
15 Months to <18 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
18 Months to <21 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
21 Months to <24 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
>=24 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Participants censored-DOR
Analysis denominator · Participants
| Group | Source count |
|---|
| ALK Positive Population (Phase 1) | 6 |
|---|
| ROS1 Positive Population (Phase 1) | 2 |
|---|
<3 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
3 Months to <6 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
6 Months to <9 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
9 Months to <12 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
12 Months to <15 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
15 Months to <18 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
18 Months to <21 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
21 Months to <24 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
>=24 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Participants with intracranial DOR
Analysis denominator · Participants
| Group | Source count |
|---|
| ALK Positive Population (Phase 1) | 3 |
|---|
| ROS1 Positive Population (Phase 1) | 0 |
|---|
<3 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
3 Months to <6 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
6 Months to <9 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
9 Months to <12 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
12 Months to <15 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
15 Months to <18 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
18 Months to <21 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
21 Months to <24 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
>=24 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Participants censored- intracranial DOR
Analysis denominator · Participants
| Group | Source count |
|---|
| ALK Positive Population (Phase 1) | 11 |
|---|
| ROS1 Positive Population (Phase 1) | 4 |
|---|
<3 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
3 Months to <6 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
6 Months to <9 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
9 Months to <12 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
12 Months to <15 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
15 Months to <18 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
18 Months to <21 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
21 Months to <24 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
>=24 Months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- <3 Months
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 0
- title
- 3 Months to <6 Months
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- 6 Months to <9 Months
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- 9 Months to <12 Months
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- 12 Months to <15 Months
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- 15 Months to <18 Months
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- 18 Months to <21 Months
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- 21 Months to <24 Months
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- title
- >=24 Months
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 4
- units
- Participants
- title
- Participants with DOR
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- <3 Months
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- 3 Months to <6 Months
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- 6 Months to <9 Months
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- 9 Months to <12 Months
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- 12 Months to <15 Months
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- 15 Months to <18 Months
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- 18 Months to <21 Months
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- 21 Months to <24 Months
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 1
- title
- >=24 Months
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 2
- units
- Participants
- title
- Participants censored-DOR
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- <3 Months
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- 3 Months to <6 Months
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- 6 Months to <9 Months
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- 9 Months to <12 Months
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- 12 Months to <15 Months
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- 15 Months to <18 Months
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- 18 Months to <21 Months
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- 21 Months to <24 Months
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- >=24 Months
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- Participants with intracranial DOR
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- title
- <3 Months
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- title
- 3 Months to <6 Months
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- 6 Months to <9 Months
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- 9 Months to <12 Months
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- 12 Months to <15 Months
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- 15 Months to <18 Months
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- title
- 18 Months to <21 Months
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- 21 Months to <24 Months
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 1
- title
- >=24 Months
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 4
- units
- Participants
- title
- Participants censored- intracranial DOR
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- Duration of response(DOR): time from first documentation of objective tumor response (CR/PR) to first documentation of disease progression (PD) or to death due to any cause, whichever occurred first. DOR: calculated for subgroup of participants with confirmed objective tumor response. Intracranial DOR: calculated for participants with confirmed intracranial objective response. CR:disappearance of all non-lymph node target lesions (where all target lesions are recorded with length of 0mm on Target Lesion eCRF). Any pathological lymph node (recorded as target lesion) must have reduction in short axis to \<10mm. PR:30% or more decrease in SLD of target lesion, taking as reference baseline SLD. PD:20% or more increase in the SLD of target lesions relative to baseline or smallest SLD (nadir) recorded since first dose. In addition, also demonstrate absolute increase of at least 5mm (\>=5mm) relative to baseline or smallest SLD (nadir) recorded since first dose.
- groups
- description
- This reporting arm includes all Phase 1 participants who had documented ALK rearrangement.
- id
- OG000
- title
- ALK Positive Population (Phase 1)
- description
- This reporting arm includes all Phase 1 participants who had documented ROS1 rearrangement.
- id
- OG001
- title
- ROS1 Positive Population (Phase 1)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- DOR analysis set included all ITT participants who had confirmed objective response; intracranial DOR analysis set included all ITT participants who had CNS metastases and achieved confirmed intracranial objective response. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data foe every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
- reporting Status
- POSTED
- time Frame
- From start of study treatment to first documentation of PD or to death due to any cause, whichever occurred first (maximum of 8 years approximately)
- title
- Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1)
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice
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