A Phase 2 interventional study of ponsegromab and Placebo for ponsegromab in Non-small Cell Lung Cancer, Pancreatic Cancer and Colorectal Cancer, sponsored by Pfizer. Completed at 78 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
Study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15.
A 12 week double blind study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15.
During the initial 12-week treatment period (Part A), a total of 3 doses of ponsegromab or placebo will be administered 4 weeks apart subcutaneously. Each dose contains two injections. Part B is an optional open-label treatment period consisting of ponsegromab administered every 4 weeks subcutaneously for up to one year. Part B does not include placebo.
Assessments include:
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 187 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
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Key Inclusion Criteria:
Key Exclusion Criteria:
ponsegromab low dose subcutaneous injection every 4 weeks
Drug: ponsegromab
Match placebo subcutaneous injection every 4 weeks
Drug: Placebo for ponsegromab
ponsegromab medium dose subcutaneous injection every 4 weeks
Drug: ponsegromab
ponsegromab high dose subcutaneous injection every 4 weeks
Drug: ponsegromab
Double-Blind ponsegromab Treatment followed by Open Label ponsegromab Treatment
Double-Blind placebo Treatment followed by Open Label ponsegromab Treatment
Part A: Change From Baseline in Body Weight at Week 12
Body weight was measured in kilograms using a calibrated weighing scale. Baseline was defined as the last average of the duplicate measurements prior to, or on Day 1. The average of the duplicate body weights collected at assessment time was considered. The posterior medians and 90 percent (%) credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for each randomized dose (including placebo). 4-Parameter maximal effect (E max) model: change from baseline = E 0 + (E max \* dose\^Hill) / (ED 50\^Hill + dose\^Hill), where E0 is the placebo effect, E max is the maximum effect, ED 50 is the dose producing 50% of the maximum effect, and Hill is the slope parameter. Model utilized a Bayesian methodology with a robustified, informative meta-analytic predictive prior for the placebo change from baseline at week 12.
Time frame: Baseline, Week 12
Part A: Change From Baseline in Physical Activity at Week 12
Physical activity was monitored using accelerometry (wearable digital sensors). Physical activity was categorized as: sedentary activity, non-sedentary physical activity, and moderate to vigorous physical activity. In this outcome measure time for each type of physical activity per day was considered. Baseline was defined as the mean taken over the 8 days of wear during screening. Mean taken over the 8 days of wear before Week 12 was considered. Analysis was performed using mixed models repeated measures (MMRM) model.
Time frame: Baseline, Week 12
Part A: Change From Baseline in Mean Activity Level During Maximum 6 Minutes at Week 12
Physical activity was monitored using accelerometry (wearable digital sensors). In this outcome measure mean activity level during maximum 6 minutes was considered. Baseline was defined as the mean taken over the 8 days of wear during screening. Mean taken over the 8 days of wear before Week 12 was considered. Analysis was performed using MMRM model.
Time frame: Baseline, Week 12
Part A: Change From Baseline in Total Vector Magnitude at Week 12
Total vector magnitude is a measure of overall physical activity. Baseline was defined as the mean taken over the 8 days of wear during screening. Mean taken over the 8 days of wear before Week 12 was considered. Analysis was performed using MMRM model.
Time frame: Baseline, Week 12
Part A: Change From Baseline in Gait at Week 12
Gait was monitored using accelerometry (wearable digital sensors). Analysis was performed using MMRM model. Gait included: gait speed and 95th percentile of gait speed. Baseline was defined as the mean taken over the 8 days of wear during screening. Mean taken over the 8 days of wear before Week 12 was considered. Analysis was performed using MMRM model.
Time frame: Baseline, Week 12
Part A: Change From Baseline in Functional Assessment of Anorexia-Cachexia Therapy- Anorexia and Cachexia Subscale (FAACT-ACS) at Week 12
FAACT-ACS is a 12-item symptom-specific subscale to measure participants' concerns about their anorexia (appetite) or cachexia (weight) for past 7 days. Each item was scored from 0 to 4, where 0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, and 4= very much. The total FAACT-ACS score ranged from 0 to 48. Higher scores are associated with a higher health-related quality of life. FAACT-ACS was analyzed using an MMRM model.
Time frame: Baseline (prior to dose on Day 1), Week 12
Part A: Change From Baseline in FAACT- 5-Item Anorexia Symptom Scale (5IASS) at Week 12
FAACT-5IASS is a 5-item subscale to measure participants' perceptions of anorexia (appetite) concerns for past 7 days. Each item was scored from 0 to 4, where 0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, and 4= very much. The total FAACT-5IASS score ranged from 0 to 20. Higher scores are associated with a higher health-related quality of life. FAACT-5IASS was analyzed using an MMRM model.
Time frame: Baseline (prior to dose on Day 1), Week 12
Part A: Change From Baseline in Cancer-Related Cachexia Symptom Diary (CRCSD) Scores at Week 12: Appetite, Nausea and Physical Fatigue
The CRCSD is a daily, self-reported questionnaire that measured severity of symptoms related to cancer cachexia: appetite, nausea, vomiting, and fatigue. Participants rated appetite, nausea and physical fatigue symptom every day, and weekly averages were calculated over the 7 days prior, from 0 to 10, where 0 = no symptom and 10 = worst possible symptom. Higher scores indicated more severe disease. CRCSD was analyzed using an MMRM model.
Time frame: Baseline, Week 12
Part A: Median Change From Baseline in CRCSD Scores at Week 12: Vomiting Frequency
The CRCSD is a daily, self-reported questionnaire that measured severity of symptoms related to cancer cachexia: vomiting frequency. Participants rated vomiting frequency over the past 24 hours, from 0 to 30, where 0 = no symptom and 30 = worst possible symptom. Higher scores indicated more severe disease.
Time frame: Baseline, Week 12
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. TEAE were defined as any event that was not present before exposure to study drug, or any event already present that worsened in either intensity or frequency after exposure to study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included serious AEs and all non-SAEs.
Time frame: From the first dose of study drug until first dose of open-label ponsegromab 400 mg for participants entering Part B or through Week 16 follow-up for participants not entering Part B (including 8 weeks of follow-up from last dose of study drug in part A)
Part A: Number of Participants With Incidence of Laboratory Test Abnormalities
Laboratory test abnormality parameters included: hematology- hemoglobin (gram per deciliter \[g/dL\]), hematocrit (%), erythrocytes (10\^12/Liter \[L\]) less than (\<) 0.8\*lower limit of normal (LLN); platelets (10\^9/L) \<0.5\*LLN to more than (\>) 1.75\*upper limit of normal (ULN); leukocytes (10\^9/L) \<0.6\*LLN to \>1.5\*ULN; lymphocytes, neutrophils (10\^9/L) \<0.8\*LLN to \>1.2\*ULN. Clinical chemistry- bilirubin, glucose (mg/dL) \>1.5\*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (Units/L \[U/L\]) \>3.0\*ULN; protein, albumin (gram \[g\]/dL) \<0.8\*LLN; urea (mmol/L) \>1.3xULN; creatinine (mg/dL) \>1.3\*ULN; sodium (milliequivalents \[mEq\]/L) \<0.95\*LLN; potassium (mEq/L) \<0.9\*LLN to \>1.1\*ULN.
Time frame: Day 1 up to Week 12
Part A: Number of Participants With Post-Baseline Vital Signs Meeting the Predefined Criteria
Vital signs criteria included: supine systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg), increase and decrease in change of more than or equal to (\>=) 30mmHg; supine diastolic blood pressure (DBP) \<50 mmHg, increase and decrease in change of \>= 20mmHg; pulse rate \<40 beats per minute (bpm) to \>120 bpm. Only rows which included at least 1 participant in any reporting group with abnormality were reported in this outcome measure.
Time frame: Day 1 up to Week 12
Part A: Number of Participants With Clinically Significant Echocardiogram (ECG) Abnormalities
ECG parameters included heart rate (HR), PR interval, QT interval, QTc corrected using Fridericia's formula (QTcF) and QRS complex. HR: RR (interval between 2 successive R waves on ECG) decrease \>25% and to a VR (interval between QRS wave and T wave on ECG) \>100, RR increase \>25% and to a VR \<50; PR interval: baseline less than or equal to (\<=) 200 and % change \>= 50%; QT interval: \>450, \>480, \>500, increase from baseline \>30, increase from baseline \>60; QTcF: 470 \< value \<= 480, 480 \< value \<= 500, value \> 500, 30 \< change \<= 60 and change \>60; QRS complex: value \>= 140, % change \>=50%. Clinically significant values were determined by the investigator.
Time frame: Day 1 up to Week 12
A total of 187 participants were enrolled in this study. This study had 2 parts: Part A and Part B. On completion of Part A, participants had the opportunity to enter open-label extension period Part B (optional).
| Milestone | Part A: Placebo/ Part B: Ponsegromab 400 mg | Part A: Ponsegromab 100 mg/ Part B: Ponsegromab 400 mg | Part A: Ponsegromab 200 mg/ Part B: Ponsegromab 400 mg | Part A: Ponsegromab 400 mg/ Part B: Ponsegromab 400 mg |
|---|---|---|---|---|
| Started | 45 | 46 | 46 | 50 |
| Completed | 32 | 32 | 39 | 34 |
| Not completed | 13 | 14 | 7 | 16 |
| Withdrew: Adverse event | 2 | 0 | 0 | 1 |
| Withdrew: Death | 4 | 4 | 5 | 6 |
| Withdrew: Lack of efficacy | 0 | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 1 |
| Withdrew: Physician decision | 1 | 0 | 0 | 0 |
| Withdrew: Progressive disease | 3 | 5 | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 | 1 | 2 |
| Withdrew: Global deterioration of health status | 2 | 2 | 1 | 4 |
| Withdrew: Other | 0 | 2 | 0 | 0 |
| Milestone | Part A: Placebo/ Part B: Ponsegromab 400 mg | Part A: Ponsegromab 100 mg/ Part B: Ponsegromab 400 mg | Part A: Ponsegromab 200 mg/ Part B: Ponsegromab 400 mg | Part A: Ponsegromab 400 mg/ Part B: Ponsegromab 400 mg |
|---|---|---|---|---|
| Started | 26 | 27 | 35 | 29 |
| Completed | 6 | 9 | 11 | 11 |
| Not completed | 20 | 18 | 24 | 18 |
| Withdrew: Death | 6 | 4 | 6 | 1 |
| Withdrew: Lack of efficacy | 1 | 0 | 1 | 0 |
| Withdrew: Physician decision | 0 | 1 | 1 | 0 |
| Withdrew: Progressive disease | 4 | 6 | 8 | 7 |
| Withdrew: Withdrawal by subject | 2 | 3 | 3 | 3 |
| Withdrew: Global deterioration of health status | 3 | 2 | 2 | 1 |
| Withdrew: Other | 3 | 1 | 1 | 1 |
| Withdrew: Adverse event | 1 | 1 | 2 | 5 |
Body weight was measured in kilograms using a calibrated weighing scale. Baseline was defined as the last average of the duplicate measurements prior to, or on Day 1. The average of the duplicate body weights collected at assessment time was considered. The posterior medians and 90 percent (%) credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for each randomized dose (including placebo). 4-Parameter maximal effect (E max) model: change from baseline = E 0 + (E max \* dose\^Hill) / (ED 50\^Hill + dose\^Hill), where E0 is the placebo effect, E max is the maximum effect, ED 50 is the dose producing 50% of the maximum effect, and Hill is the slope parameter. Model utilized a Bayesian methodology with a robustified, informative meta-analytic predictive prior for the placebo change from baseline at week 12.
| Kilogram | Part A: Placebo | Part A: Ponsegromab 100 mg | Part A: Ponsegromab 200 mg | Part A: Ponsegromab 400 mg |
|---|---|---|---|---|
| Part A: Change From Baseline in Body Weight at Week 12 | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) |
Physical activity was monitored using accelerometry (wearable digital sensors). Physical activity was categorized as: sedentary activity, non-sedentary physical activity, and moderate to vigorous physical activity. In this outcome measure time for each type of physical activity per day was considered. Baseline was defined as the mean taken over the 8 days of wear during screening. Mean taken over the 8 days of wear before Week 12 was considered. Analysis was performed using mixed models repeated measures (MMRM) model.
| Minutes per day | Part A: Placebo | Part A: Ponsegromab 100 mg | Part A: Ponsegromab 200 mg | Part A: Ponsegromab 400 mg |
|---|---|---|---|---|
| Time for Sedentary Activity | -1.42 (-72.77 to 69.92) | 51.93 (-9.88 to 113.75) | -39.33 (-101.94 to 23.29) | -3.37 (-72.89 to 66.14) |
| Time for Non-Sedentary Physical Activity | -37.73 (-66.14 to -9.32) | 0.03 (-24.88 to 24.95) | -42.09 (-67.63 to -16.56) | 12.11 (-14.87 to 39.10) |
| Time for Moderate to Vigorous Physical Activity | -4.45 (-13.91 to 5.02) | 4.07 (-4.18 to 12.32) | 0.05 (-8.29 to 8.39) | 3.67 (-5.37 to 12.71) |
Physical activity was monitored using accelerometry (wearable digital sensors). In this outcome measure mean activity level during maximum 6 minutes was considered. Baseline was defined as the mean taken over the 8 days of wear during screening. Mean taken over the 8 days of wear before Week 12 was considered. Analysis was performed using MMRM model.
| Arbitrary units per day (au/day) | Part A: Placebo | Part A: Ponsegromab 100 mg | Part A: Ponsegromab 200 mg | Part A: Ponsegromab 400 mg |
|---|---|---|---|---|
| Part A: Change From Baseline in Mean Activity Level During Maximum 6 Minutes at Week 12 | 70.81 (-785.82 to 927.45) | -59.46 (-794.41 to 675.49) | 794.96 (39.43 to 1550.48) | 256.43 (-561.29 to 1074.16) |
Total vector magnitude is a measure of overall physical activity. Baseline was defined as the mean taken over the 8 days of wear during screening. Mean taken over the 8 days of wear before Week 12 was considered. Analysis was performed using MMRM model.
| Total activity counts/100 per day | Part A: Placebo | Part A: Ponsegromab 100 mg | Part A: Ponsegromab 200 mg | Part A: Ponsegromab 400 mg |
|---|---|---|---|---|
| Part A: Change From Baseline in Total Vector Magnitude at Week 12 | -1919.02 (-3450.37 to -387.68) | -331.76 (-1679.81 to 1016.29) | -2017.57 (-3387.48 to -647.65) | 284.15 (-1175.46 to 1743.77) |
Gait was monitored using accelerometry (wearable digital sensors). Analysis was performed using MMRM model. Gait included: gait speed and 95th percentile of gait speed. Baseline was defined as the mean taken over the 8 days of wear during screening. Mean taken over the 8 days of wear before Week 12 was considered. Analysis was performed using MMRM model.
| Meter per second (m/s) | Part A: Placebo | Part A: Ponsegromab 100 mg | Part A: Ponsegromab 200 mg | Part A: Ponsegromab 400 mg |
|---|---|---|---|---|
| Gait Speed | -0.008 (-0.042 to 0.026) | -0.009 (-0.040 to 0.023) | -0.012 (-0.044 to 0.019) | 0.009 (-0.024 to 0.042) |
| 95th percentile of gait speed | 0.011 (-0.041 to 0.064) | 0.011 (-0.037 to 0.059) | -0.015 (-0.063 to 0.033) | 0.021 (-0.030 to 0.072) |
FAACT-ACS is a 12-item symptom-specific subscale to measure participants' concerns about their anorexia (appetite) or cachexia (weight) for past 7 days. Each item was scored from 0 to 4, where 0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, and 4= very much. The total FAACT-ACS score ranged from 0 to 48. Higher scores are associated with a higher health-related quality of life. FAACT-ACS was analyzed using an MMRM model.
| Units on a scale | Part A: Placebo | Part A: Ponsegromab 100 mg | Part A: Ponsegromab 200 mg | Part A: Ponsegromab 400 mg |
|---|---|---|---|---|
| Part A: Change From Baseline in Functional Assessment of Anorexia-Cachexia Therapy- Anorexia and Cachexia Subscale (FAACT-ACS) at Week 12 | 0.52 (-1.60 to 2.63) | 4.76 (2.54 to 6.97) | 1.15 (-0.90 to 3.20) | 4.63 (2.40 to 6.85) |
FAACT-5IASS is a 5-item subscale to measure participants' perceptions of anorexia (appetite) concerns for past 7 days. Each item was scored from 0 to 4, where 0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, and 4= very much. The total FAACT-5IASS score ranged from 0 to 20. Higher scores are associated with a higher health-related quality of life. FAACT-5IASS was analyzed using an MMRM model.
| Units on a scale | Part A: Placebo | Part A: Ponsegromab 100 mg | Part A: Ponsegromab 200 mg | Part A: Ponsegromab 400 mg |
|---|---|---|---|---|
| Part A: Change From Baseline in FAACT- 5-Item Anorexia Symptom Scale (5IASS) at Week 12 | 0.15 (-0.97 to 1.27) | 2.50 (1.32 to 3.67) | 0.15 (-0.94 to 1.24) | 2.45 (1.28 to 3.62) |
The CRCSD is a daily, self-reported questionnaire that measured severity of symptoms related to cancer cachexia: appetite, nausea, vomiting, and fatigue. Participants rated appetite, nausea and physical fatigue symptom every day, and weekly averages were calculated over the 7 days prior, from 0 to 10, where 0 = no symptom and 10 = worst possible symptom. Higher scores indicated more severe disease. CRCSD was analyzed using an MMRM model.
| Units on a scale | Part A: Placebo | Part A: Ponsegromab 100 mg | Part A: Ponsegromab 200 mg | Part A: Ponsegromab 400 mg |
|---|---|---|---|---|
| Appetite | -0.23 (-0.83 to 0.37) | 0.20 (-0.36 to 0.76) | 0.23 (-0.37 to 0.82) | 0.69 (0.11 to 1.27) |
| Nausea | -0.33 (-0.82 to 0.17) | 0.14 (-0.32 to 0.61) | 0.06 (-0.43 to 0.55) | -0.50 (-0.98 to -0.02) |
| Physical Fatigue | -0.27 (-0.85 to 0.32) | 0.39 (-0.16 to 0.94) | 0.38 (-0.21 to 0.96) | -0.06 (-0.63 to 0.51) |
The CRCSD is a daily, self-reported questionnaire that measured severity of symptoms related to cancer cachexia: vomiting frequency. Participants rated vomiting frequency over the past 24 hours, from 0 to 30, where 0 = no symptom and 30 = worst possible symptom. Higher scores indicated more severe disease.
| Units on a scale | Part A: Placebo | Part A: Ponsegromab 100 mg | Part A: Ponsegromab 200 mg | Part A: Ponsegromab 400 mg |
|---|---|---|---|---|
| Part A: Median Change From Baseline in CRCSD Scores at Week 12: Vomiting Frequency | 0.00 (0.0 to 0.0) | 0.00 (0.0 to 0.0) | 0.00 (0.0 to 0.0) | 0.00 (0.0 to 0.0) |
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. TEAE were defined as any event that was not present before exposure to study drug, or any event already present that worsened in either intensity or frequency after exposure to study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included serious AEs and all non-SAEs.
| Participants | Part A: Placebo | Part A: Ponsegromab 100 mg | Part A: Ponsegromab 200 mg | Part A: Ponsegromab 400 mg |
|---|---|---|---|---|
| Part A: Number of Participants With Treatment Emergent Adverse Events (TEAE) | 36 | 32 | 31 | 37 |
Laboratory test abnormality parameters included: hematology- hemoglobin (gram per deciliter \[g/dL\]), hematocrit (%), erythrocytes (10\^12/Liter \[L\]) less than (\<) 0.8\*lower limit of normal (LLN); platelets (10\^9/L) \<0.5\*LLN to more than (\>) 1.75\*upper limit of normal (ULN); leukocytes (10\^9/L) \<0.6\*LLN to \>1.5\*ULN; lymphocytes, neutrophils (10\^9/L) \<0.8\*LLN to \>1.2\*ULN. Clinical chemistry- bilirubin, glucose (mg/dL) \>1.5\*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (Units/L \[U/L\]) \>3.0\*ULN; protein, albumin (gram \[g\]/dL) \<0.8\*LLN; urea (mmol/L) \>1.3xULN; creatinine (mg/dL) \>1.3\*ULN; sodium (milliequivalents \[mEq\]/L) \<0.95\*LLN; potassium (mEq/L) \<0.9\*LLN to \>1.1\*ULN.
| Participants | Part A: Placebo | Part A: Ponsegromab 100 mg | Part A: Ponsegromab 200 mg | Part A: Ponsegromab 400 mg |
|---|---|---|---|---|
| Part A: Number of Participants With Incidence of Laboratory Test Abnormalities | 26 | 24 | 29 | 28 |
Vital signs criteria included: supine systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg), increase and decrease in change of more than or equal to (\>=) 30mmHg; supine diastolic blood pressure (DBP) \<50 mmHg, increase and decrease in change of \>= 20mmHg; pulse rate \<40 beats per minute (bpm) to \>120 bpm. Only rows which included at least 1 participant in any reporting group with abnormality were reported in this outcome measure.
| Participants | Part A: Placebo | Part A: Ponsegromab 100 mg | Part A: Ponsegromab 200 mg | Part A: Ponsegromab 400 mg |
|---|---|---|---|---|
| Supine SBP Value < 90mmHg | 0 | 3 | 0 | 0 |
| Supine SBP Increase Change >= 30mmHg | 4 | 5 | 8 | 2 |
| Supine SBP Decrease Change >= 30mmHg | 2 | 6 | 5 | 4 |
| Supine DBP Value < 50mmHg | 0 | 1 | 0 | 0 |
| Supine SBP Increase Change >= 20mmHg | 4 | 4 | 3 | 4 |
| Supine DBP Decrease Change >= 20mmHg | 3 | 4 | 4 | 3 |
| Supine Pulse Rate Value > 120mmHg | 0 | 1 | 3 | 1 |
ECG parameters included heart rate (HR), PR interval, QT interval, QTc corrected using Fridericia's formula (QTcF) and QRS complex. HR: RR (interval between 2 successive R waves on ECG) decrease \>25% and to a VR (interval between QRS wave and T wave on ECG) \>100, RR increase \>25% and to a VR \<50; PR interval: baseline less than or equal to (\<=) 200 and % change \>= 50%; QT interval: \>450, \>480, \>500, increase from baseline \>30, increase from baseline \>60; QTcF: 470 \< value \<= 480, 480 \< value \<= 500, value \> 500, 30 \< change \<= 60 and change \>60; QRS complex: value \>= 140, % change \>=50%. Clinically significant values were determined by the investigator.
| Participants | Part A: Placebo | Part A: Ponsegromab 100 mg | Part A: Ponsegromab 200 mg | Part A: Ponsegromab 400 mg |
|---|---|---|---|---|
| Part A: Number of Participants With Clinically Significant Echocardiogram (ECG) Abnormalities | 0 | 0 | 0 | 0 |
Collected over Part A: from the first dose of study drug until first dose of open label ponsegromab 400 mg for participants entering Part B or through Week 16 follow-up for participants not entering Part B (including 8 weeks of follow-up from last dose of study drug in part A). Part B: from the first dose of open label ponsegromab 400 mg up to approximately Week 72 (including 8 weeks follow up post last dose in Part B). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part A: Placebo | 5/45 (11.1%) | 11/45 (24.4%) | 26/45 (57.8%) |
| Part A: Ponsegromab 100 mg | 6/46 (13%) | 15/46 (32.6%) | 22/46 (47.8%) |
| Part A: Ponsegromab 200 mg | 6/46 (13%) | 10/46 (21.7%) | 19/46 (41.3%) |
| Part A: Ponsegromab 400 mg | 9/50 (18%) | 20/50 (40%) | 24/50 (48%) |
| Part A: Placebo/ Part B: Ponsegromab 400 mg | 8/24 (33.3%) | 9/24 (37.5%) | 16/24 (66.7%) |
| Part A: Ponsegromab 100 mg/ Part B: Ponsegromab 400 mg | 10/27 (37%) | 14/27 (51.9%) | 22/27 (81.5%) |
| Part A: Ponsegromab 200 mg/ Part B: Ponsegromab 400 mg | 13/34 (38.2%) | 16/34 (47.1%) | 24/34 (70.6%) |
| Part A: Ponsegromab 400 mg/ Part B: Ponsegromab 400 mg | 5/29 (17.2%) | 11/29 (37.9%) | 19/29 (65.5%) |
| Event | Part A: Placebo | Part A: Ponsegromab 100 mg | Part A: Ponsegromab 200 mg | Part A: Ponsegromab 400 mg | Part A: Placebo/ Part B: Ponsegromab 400 mg | Part A: Ponsegromab 100 mg/ Part B: Ponsegromab 400 mg | Part A: Ponsegromab 200 mg/ Part B: Ponsegromab 400 mg | Part A: Ponsegromab 400 mg/ Part B: Ponsegromab 400 mg |
|---|---|---|---|---|---|---|---|---|
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/45 | 1/46 | 3/46 | 3/50 | 3/24 | 7/27 | 2/34 | 2/29 |
| Neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/45 | 2/46 | 2/46 | 2/50 | 1/24 | 1/27 | 3/34 | 0/29 |
| PneumoniaInfections and infestations | 1/45 | 1/46 | 2/46 | 3/50 | 2/24 | 1/27 | 0/34 | 1/29 |
| Intestinal obstructionGastrointestinal disorders | 0/45 | 0/46 | 0/46 | 0/50 | 0/24 | 0/27 | 0/34 | 2/29 |
| Abdominal painGastrointestinal disorders | 0/45 | 2/46 | 0/46 | 1/50 | 0/24 | 0/27 | 0/34 | 0/29 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/45 | 0/46 | 0/46 | 0/50 | 1/24 | 0/27 | 0/34 | 0/29 |
| DiarrhoeaGastrointestinal disorders | 0/45 | 0/46 | 0/46 | 0/50 | 1/24 | 1/27 | 0/34 | 0/29 |
| IleusGastrointestinal disorders | 0/45 | 0/46 | 0/46 | 1/50 | 1/24 | 0/27 | 0/34 | 0/29 |
| SubileusGastrointestinal disorders | 0/45 | 0/46 | 0/46 | 0/50 | 1/24 | 0/27 | 0/34 | 0/29 |
| InfluenzaInfections and infestations | 0/45 | 0/46 | 0/46 | 0/50 | 1/24 | 0/27 | 1/34 | 0/29 |
| Event | Part A: Placebo | Part A: Ponsegromab 100 mg | Part A: Ponsegromab 200 mg | Part A: Ponsegromab 400 mg | Part A: Placebo/ Part B: Ponsegromab 400 mg | Part A: Ponsegromab 100 mg/ Part B: Ponsegromab 400 mg | Part A: Ponsegromab 200 mg/ Part B: Ponsegromab 400 mg | Part A: Ponsegromab 400 mg/ Part B: Ponsegromab 400 mg |
|---|---|---|---|---|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 8/45 | 3/46 | 4/46 | 5/50 | 9/24 | 2/27 | 3/34 | 3/29 |
| AnaemiaBlood and lymphatic system disorders | 5/45 | 5/46 | 5/46 | 4/50 | 4/24 | 6/27 | 3/34 | 1/29 |
| HypoalbuminaemiaMetabolism and nutrition disorders | 0/45 | 0/46 | 0/46 | 0/50 | 5/24 | 1/27 | 1/34 | 0/29 |
| ConstipationGastrointestinal disorders | 4/45 | 3/46 | 2/46 | 3/50 | 0/24 | 3/27 | 2/34 | 5/29 |
| PyrexiaGeneral disorders | 3/45 | 0/46 | 5/46 | 4/50 | 4/24 | 3/27 | 3/34 | 3/29 |
| NauseaGastrointestinal disorders | 7/45 | 1/46 | 1/46 | 4/50 | 1/24 | 2/27 | 1/34 | 1/29 |
| FatigueGeneral disorders | 2/45 | 1/46 | 1/46 | 4/50 | 1/24 | 2/27 | 5/34 | 2/29 |
| HypokalaemiaMetabolism and nutrition disorders | 4/45 | 6/46 | 0/46 | 6/50 | 3/24 | 2/27 | 1/34 | 3/29 |
| Abdominal distensionGastrointestinal disorders | 0/45 | 0/46 | 0/46 | 0/50 | 3/24 | 1/27 | 0/34 | 0/29 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/45 | 0/46 | 0/46 | 0/50 | 2/24 | 1/27 | 4/34 | 0/29 |
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
| Age, Continuous(Years) | Part A: Placebo/ Part B: Ponsegromab 400 mg | Part A: Ponsegromab 100 mg/ Part B: Ponsegromab 400 mg | Part A: Ponsegromab 200 mg/ Part B: Ponsegromab 400 mg | Part A: Ponsegromab 400 mg/ Part B: Ponsegromab 400 mg | Total |
|---|---|---|---|---|---|
| Mean | 63.2 ± 11.26 | 70.1 ± 9.38 | 65.9 ± 9.61 | 66.1 ± 9.93 | 66.4 ± 10.28 |
| Sex: Female, Male(Participants) | Part A: Placebo/ Part B: Ponsegromab 400 mg | Part A: Ponsegromab 100 mg/ Part B: Ponsegromab 400 mg | Part A: Ponsegromab 200 mg/ Part B: Ponsegromab 400 mg | Part A: Ponsegromab 400 mg/ Part B: Ponsegromab 400 mg | Total |
|---|---|---|---|---|---|
| Female | 17 | 19 | 15 | 18 | 69 |
| Male | 28 | 27 | 31 | 32 | 118 |
| Ethnicity (NIH/OMB)(Participants) | Part A: Placebo/ Part B: Ponsegromab 400 mg | Part A: Ponsegromab 100 mg/ Part B: Ponsegromab 400 mg | Part A: Ponsegromab 200 mg/ Part B: Ponsegromab 400 mg | Part A: Ponsegromab 400 mg/ Part B: Ponsegromab 400 mg | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 | 5 | 9 |
| Not Hispanic or Latino | 43 | 42 | 44 | 43 | 172 |
| Unknown or Not Reported | 1 | 3 | 0 | 2 | 6 |
| Race (NIH/OMB)(Participants) | Part A: Placebo/ Part B: Ponsegromab 400 mg | Part A: Ponsegromab 100 mg/ Part B: Ponsegromab 400 mg | Part A: Ponsegromab 200 mg/ Part B: Ponsegromab 400 mg | Part A: Ponsegromab 400 mg/ Part B: Ponsegromab 400 mg | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 18 | 19 | 18 | 15 | 70 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 |
| White | 26 | 27 | 28 | 35 | 116 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 0 | 0 | 1 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Carcinoma, Non-Small-Cell Lung→
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