18 and older, any sex, with Cachexia or Non-Small-Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)Primary· From Day 1 up to Week 24
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. An AE was considered an TEAE if the event started during the effective duration
AEs
Group
Value
95% CI
PF-06946860 Q3W
10
SAEs
Group
Value
95% CI
PF-06946860 Q3W
4
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)Primary· From Day 1 up to Week 24
Participants with laboratory test abnormalities (without regard to baseline abnormality) that met pre-specified criteria included Hemoglobin\< 0.8x lower limit of normal (LLN); Hematocrit\< 0.8x LLN; Erythrocytes (Ery.)\< 0.8x LLN; Ery. Mean Corpuscular Volume\< 0.9x LLN; Leukocytes\< 0.6x LLN; Lymphocytes\< 0.8x LLN; Bilirubin\> 1.5x upper limit of normal (ULN); Aspartate Aminotransferase\> 3.0x ULN; Alkaline Phosphatase\> 3.0x ULN; Protein\< 0.8x LLN; Sodium\< 0.95x LLN; Chloride\< 0.9x LLN; Calcium\< 0.9x LLN; Bicarbonate\< 0.9x LLN; Glucose\> 1.5x ULN; C Reactive Protein\> 1.1x ULN; for ur
Hemoglobin (g/dL)< 0.8x LLN
Group
Value
95% CI
PF-06946860 Q3W
2
Hematocrit (%)< 0.8x LLN
Group
Value
95% CI
PF-06946860 Q3W
2
Erythrocytes (10^6/mm^3)< 0.8x LLN
Group
Value
95% CI
PF-06946860 Q3W
2
Ery. Mean Corpuscular Volume (um^3)< 0.9x LLN
Group
Value
95% CI
PF-06946860 Q3W
1
Leukocytes (10^3/mm^3)< 0.6x LLN
Group
Value
95% CI
PF-06946860 Q3W
2
Lymphocytes (10^3/mm^3)< 0.8x LLN
Group
Value
95% CI
PF-06946860 Q3W
3
Bilirubin (mg/dL)> 1.5x ULN
Group
Value
95% CI
PF-06946860 Q3W
1
Aspartate Aminotransferase (U/L)> 3.0x ULN
Group
Value
95% CI
PF-06946860 Q3W
1
Number of Participants With Post-Baseline Vital Signs AbnormalitiesPrimary· From Day 1 up to Week 24
Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the supine position. The pre-specified categorical analysis criteria in vital signs, were supine systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg), supine SBP increase/decrease from baseline ≥30 mmHg; supine diastolic blood pressure (DBP) \<50 mmHg, supine DBP increase/decrease from baseline ≥20 mmHg; supine pulse rate \<40 beats per minute (bpm) or \>120 bpm.
Supine SBP - Value <90 mmHg
Group
Value
95% CI
PF-06946860 Q3W
0
Supine SBP - Change ≥ 30 mmHg Increase
Group
Value
95% CI
PF-06946860 Q3W
2
Supine SBP - Change ≥ 30 mmHg Decrease
Group
Value
95% CI
PF-06946860 Q3W
0
Supine DBP - Value <50 mmHg
Group
Value
95% CI
PF-06946860 Q3W
0
Supine DBP - Change ≥ 20 mmHg Increase
Group
Value
95% CI
PF-06946860 Q3W
1
Supine DBP - Change ≥ 20 mmHg Decrease
Group
Value
95% CI
PF-06946860 Q3W
0
Supine Pulse Rate - Value <40 bpm
Group
Value
95% CI
PF-06946860 Q3W
0
Supine Pulse Rate - Value >120 bpm
Group
Value
95% CI
PF-06946860 Q3W
0
Number of Participants With Post-Baseline Electrocardiogram (ECG) AbnormalitiesPrimary· From Day 1 up to Week 24
ECG data (PR interval, QRS interval, QT interval, and QTcF) were obtained with participant in the supine position. The pre-specified categorical analysis criteria in ECG, were PR interval: value ≥300 milliseconds (msec), percentage change ≥25/50%; QRS interval: value ≥140 msec, percentage change ≥50%; QT interval: value ≥500 msec; QTcF interval: 470\< value ≤480 msec, 480\< value ≤500 msec, value \>500 msec, and 30\< change ≤60 msec, change \>60 msec.
Supine PR Interval - Value ≥300 msec
Group
Value
95% CI
PF-06946860 Q3W
0
Supine PR Interval - %Chg ≥25/50%
Group
Value
95% CI
PF-06946860 Q3W
0
Supine QRS Interval - Value ≥140 msec
Group
Value
95% CI
PF-06946860 Q3W
0
Supine QRS Interval - %Chg ≥50%
Group
Value
95% CI
PF-06946860 Q3W
0
Supine QT Interval - Value ≥500 msec
Group
Value
95% CI
PF-06946860 Q3W
0
Supine QTcF - 470<Value≤480 msec
Group
Value
95% CI
PF-06946860 Q3W
0
Supine QTcF - 480<Value≤500 msec
Group
Value
95% CI
PF-06946860 Q3W
0
Supine QTcF - Value>500 msec
Group
Value
95% CI
PF-06946860 Q3W
0
Serum Unbound Trough Concentrations (Ctrough) of PF-06946860Secondary· Pre-dose at Weeks 3, 6, 9 and 12, and at Week 15
Ctrough was defined as the samples measured pre-dose at Weeks 3, 6, 9 and 12, and at Week 15. Serum unbound Ctrough was summarized by time and treatment group.
Week 3
Group
Value
95% CI
PF-06946860 Q3W
4.041
± 1.28*10^19
Week 6
Group
Value
95% CI
PF-06946860 Q3W
1690
± 593
Week 9
Group
Value
95% CI
PF-06946860 Q3W
610.9
± 7.79*10^10
Week 12
Group
Value
95% CI
PF-06946860 Q3W
4383
± 142
Week 15
Group
Value
95% CI
PF-06946860 Q3W
560.5
± 2.15*10^12
Serum Total Ctrough of PF-06946860Secondary· Pre-dose at Weeks 3, 6, 9 and 12, and at Week 15
Ctrough was defined as the samples measured pre-dose at Weeks 3, 6, 9 and 12, and at Week 15. Serum total Ctrough was summarized by time and treatment group.
Week 3
Group
Value
95% CI
PF-06946860 Q3W
10050
± 19
Week 6
Group
Value
95% CI
PF-06946860 Q3W
17010
± 16
Week 9
Group
Value
95% CI
PF-06946860 Q3W
20740
± 24
Week 12
Group
Value
95% CI
PF-06946860 Q3W
21310
± 32
Week 15
Group
Value
95% CI
PF-06946860 Q3W
25450
± 31
Adverse events — posted to ClinicalTrials.gov
Time frame: From Day 1 up to Week 24.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
PF-06946860 Q3W
Serious: 4/10 (40%)
Deaths: 1/10
Serious adverse events (5 terms)
Reaction
System
PF-06946860 Q3W
Anaemia
Blood and lymphatic system disorders
—
Cholecystitis acute
Hepatobiliary disorders
—
Sepsis
Infections and infestations
—
Transaminases increased
Investigations
—
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 14 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04299048.