CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 187 enrolled / 187 target
Drug / intervention
ponsegromab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05546476
NCT05546476Phase 2CompletedMonitor (4.3/mo)Completion was 27mo ago
CompareCT.gov

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PONSEGROMAB IN PATIENTS WITH CANCER, CACHEXIA, AND ELEVATED CONCENTRATIONS OF GDF-15, FOLLOWED BY AN OPTIONAL OPEN-LABEL TREATMENT PERIOD (PROACC -1)

Pfizer·interventional·Posted Sep 19, 2022·Updated Jun 3, 2026

In Brief

A Phase 2 clinical trial evaluating ponsegromab and Placebo for ponsegromab for Non-small Cell Lung Cancer and 5 related conditions. Completed, enrolled 187 participants across 78 sites in 11 countries.

Signals

Enrolling slower than its timeline implies

Detailed Summary

Study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-small Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer, Loss of Appetite, Fatigue, Cachexia
CountriesAustralia, Bulgaria, Canada, China, Hungary, Japan, Poland, Slovakia, Spain, Taiwan, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedSep 19, 2022
Enrollment StartNov 21, 2022
Primary CompletionMar 13, 2024
Study CompletionApr 23, 2025
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 3.8 years ago

Arms & Interventions

Double-Blind ponsegromab Treatment low dose followed by Open Label ponsegromab Treatmentexperimental

ponsegromab low dose subcutaneous injection every 4 weeks

Drug: ponsegromab
Double-Blind Placebo Treatment followed by Open-Label ponsegromab Treatmentplacebo_comparator

Match placebo subcutaneous injection every 4 weeks

Drug: Placebo for ponsegromab
Double-Blind ponsegromab Treatment medium dose followed by Open Label ponsegromab Treatmentexperimental

ponsegromab medium dose subcutaneous injection every 4 weeks

Drug: ponsegromab
Double-Blind ponsegromab Treatment high dose followed by Open Label ponsegromab Treatmentexperimental

ponsegromab high dose subcutaneous injection every 4 weeks

Drug: ponsegromab

Interventions

ponsegromabdrug

Double-Blind ponsegromab Treatment followed by Open Label ponsegromab Treatment

Placebo for ponsegromabdrug

Double-Blind placebo Treatment followed by Open Label ponsegromab Treatment