Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
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 first dose of study treatment to end of treatment (maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)
What was measured
EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms, and improvement was defined as a decrease of at least 10 points, worsening was defined as an increase of at least 10 points. All scales which had not improved nor worsened were considered stable.
Analysis population: Patient reported outcome (PRO) evaluable analysis set included all enrolled participants who received at least 1 dose of PF-06463922 and completed a baseline and at least 1 post-baseline PRO assessment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Groups in this outcome
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
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
EXP-1 (Phase 2)
30
EXP-2 (Phase 2)
26
EXP-3 (Phase 2)
55
EXP-4 (Phase 2)
60
EXP-5 (Phase 2)
43
EXP-6 (Phase 2)
41
DDI Sub-study
32
Reported measurements
Improved in dyspnea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
11
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
21
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
12
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
12
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
6
Not reported
Not reported
Not reported
Not reported
Stable in dyspnea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
16
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
18
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
36
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
25
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
21
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
23
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
18
Not reported
Not reported
Not reported
Not reported
Worsened in dyspnea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
3
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
3
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
14
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
6
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
8
Not reported
Not reported
Not reported
Not reported
Missing-dyspnea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
0
Not reported
Not reported
Not reported
Not reported
Improved in coughing
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
18
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
22
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
26
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
18
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
17
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
16
Not reported
Not reported
Not reported
Not reported
Stable in coughing
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
13
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
26
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
28
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
15
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
18
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
15
Not reported
Not reported
Not reported
Not reported
Worsened in coughing
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
3
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
4
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
7
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
6
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
6
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
1
Not reported
Not reported
Not reported
Not reported
Missing-coughing
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
0
Not reported
Not reported
Not reported
Not reported
Improved in hemoptysis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
4
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
7
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
4
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
1
Not reported
Not reported
Not reported
Not reported
Stable in hemoptysis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
24
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
25
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
47
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
52
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
34
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
36
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
31
Not reported
Not reported
Not reported
Not reported
Worsened in hemoptysis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
3
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
3
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
0
Not reported
Not reported
Not reported
Not reported
Missing-hemoptysis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
0
Not reported
Not reported
Not reported
Not reported
Improved in sore mouth
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
4
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
4
Not reported
Not reported
Not reported
Not reported
Stable in sore mouth
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
25
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
20
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
44
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
41
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
33
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
28
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
26
Not reported
Not reported
Not reported
Not reported
Worsened in sore mouth
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
4
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
7
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
7
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
8
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
2
Not reported
Not reported
Not reported
Not reported
Missing-sore mouth
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
0
Not reported
Not reported
Not reported
Not reported
Improved in dysphagia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
3
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
3
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
7
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
4
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
3
Not reported
Not reported
Not reported
Not reported
Stable in dysphagia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
23
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
24
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
46
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
48
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
33
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
30
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
27
Not reported
Not reported
Not reported
Not reported
Worsened in dysphagia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
4
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
6
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
6
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
2
Not reported
Not reported
Not reported
Not reported
Missing-dysphagia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
0
Not reported
Not reported
Not reported
Not reported
Improved in peripheral neuropathy
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
4
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
6
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
9
Not reported
Not reported
Not reported
Not reported
Stable in peripheral neuropathy
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
13
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
27
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
33
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
22
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
18
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
16
Not reported
Not reported
Not reported
Not reported
Worsened in peripheral neuropathy
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
16
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
8
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
19
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
22
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
14
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
14
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
7
Not reported
Not reported
Not reported
Not reported
Missing-peripheral neuropathy
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
0
Not reported
Not reported
Not reported
Not reported
Improved in alopecia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
4
Not reported
Not reported
Not reported
Not reported
Stable in alopecia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
18
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
22
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
41
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
40
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
24
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
27
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
21
Not reported
Not reported
Not reported
Not reported
Worsened in alopecia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
3
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
12
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
8
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
7
Not reported
Not reported
Not reported
Not reported
Missing-alopecia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
0
Not reported
Not reported
Not reported
Not reported
Improved in chest pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
11
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
7
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
13
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
18
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
14
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
14
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
13
Not reported
Not reported
Not reported
Not reported
Stable in chest pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
17
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
17
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
35
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
33
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
25
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
24
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
17
Not reported
Not reported
Not reported
Not reported
Worsened in chest pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
6
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
3
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
3
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
2
Not reported
Not reported
Not reported
Not reported
Missing-chest pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
0
Not reported
Not reported
Not reported
Not reported
Improved in arm or shoulder pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
14
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
14
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
12
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
12
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
9
Not reported
Not reported
Not reported
Not reported
Stable in arm or shoulder pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
15
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
19
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
30
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
36
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
21
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
22
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
19
Not reported
Not reported
Not reported
Not reported
Worsened in arm or shoulder pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
11
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
7
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
4
Not reported
Not reported
Not reported
Not reported
Missing- arm or shoulder pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
0
Not reported
Not reported
Not reported
Not reported
Improved in pain in other parts
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
6
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
17
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
20
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
15
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
17
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
9
Not reported
Not reported
Not reported
Not reported
Stable in pain in other parts
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
14
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
15
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
23
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
24
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
18
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
10
Not reported
Not reported
Not reported
Not reported
Worsened in pain in other parts
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
7
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
15
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
16
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
17
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
6
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
12
Not reported
Not reported
Not reported
Not reported
Missing-Pain in other parts
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
1
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
11
group Id
OG001
value
5
group Id
OG002
value
9
group Id
OG003
value
21
group Id
OG004
value
12
group Id
OG005
value
12
group Id
OG006
value
6
title
Improved in dyspnea
categories
measurements
group Id
OG000
value
16
group Id
OG001
value
18
group Id
OG002
value
36
group Id
OG003
value
25
group Id
OG004
value
21
group Id
OG005
value
23
group Id
OG006
value
18
title
Stable in dyspnea
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
10
group Id
OG003
value
14
group Id
OG004
value
9
group Id
OG005
value
6
group Id
OG006
value
8
title
Worsened in dyspnea
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
1
group Id
OG005
value
0
group Id
OG006
value
0
title
Missing-dyspnea
categories
measurements
group Id
OG000
value
18
group Id
OG001
value
9
group Id
OG002
value
22
group Id
OG003
value
26
group Id
OG004
value
18
group Id
OG005
value
17
group Id
OG006
value
16
title
Improved in coughing
categories
measurements
group Id
OG000
value
9
group Id
OG001
value
13
group Id
OG002
value
26
group Id
OG003
value
28
group Id
OG004
value
15
group Id
OG005
value
18
group Id
OG006
value
15
title
Stable in coughing
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
4
group Id
OG002
value
7
group Id
OG003
value
6
group Id
OG004
value
9
group Id
OG005
value
6
group Id
OG006
value
1
title
Worsened in coughing
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
1
group Id
OG005
value
0
group Id
OG006
value
0
title
Missing-coughing
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
0
group Id
OG002
value
7
group Id
OG003
value
5
group Id
OG004
value
5
group Id
OG005
value
4
group Id
OG006
value
1
title
Improved in hemoptysis
categories
measurements
group Id
OG000
value
24
group Id
OG001
value
25
group Id
OG002
value
47
group Id
OG003
value
52
group Id
OG004
value
34
group Id
OG005
value
36
group Id
OG006
value
31
title
Stable in hemoptysis
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
3
group Id
OG004
value
3
group Id
OG005
value
1
group Id
OG006
value
0
title
Worsened in hemoptysis
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
1
group Id
OG005
value
0
group Id
OG006
value
0
title
Missing-hemoptysis
denoms
counts
group Id
OG000
value
30
group Id
OG001
value
26
group Id
OG002
value
55
group Id
OG003
value
60
group Id
OG004
value
43
group Id
OG005
value
41
group Id
OG006
value
32
units
Participants
description
EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms, and improvement was defined as a decrease of at least 10 points, worsening was defined as an increase of at least 10 points. All scales which had not improved nor worsened were considered stable.
groups
description
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG000
title
EXP-1 (Phase 2)
description
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG001
title
EXP-2 (Phase 2)
description
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG002
title
EXP-3 (Phase 2)
description
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG003
title
EXP-4 (Phase 2)
description
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG004
title
EXP-5 (Phase 2)
description
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG005
title
EXP-6 (Phase 2)
description
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
id
OG006
title
DDI Sub-study
param Type
COUNT_OF_PARTICIPANTS
population Description
Patient reported outcome (PRO) evaluable analysis set included all enrolled participants who received at least 1 dose of PF-06463922 and completed a baseline and at least 1 post-baseline PRO assessment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
From first dose of study treatment to end of treatment (maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)
title
Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2 and DDI Sub-study)
Triangle