A Study to Learn About the Study Medicine Called Ponsegromab in Adults With Lung Cancer-Associated Significant Weight Loss
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer
About this trial
Study to investigate the effect of ponsegromab on skeletal muscle mass and physical function in adult participants with non-small cell lung cancer associated cachexia.
Eligibility criteria
Qualifiers
Signed Informed Consent
locally advanced, unresectable, stage III disease (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system); and
measurable disease at time of screening (assessment per RECIST v1.1); and
must have completed platinum-based chemotherapy concurrent with radiation therapy, within 7 to 42 days prior to the randomization; and
Disqualifiers
NCI CTCAE Grade 3 or 4 oral mucositis
Mechanical obstructions interfering with the participant's ability to eat
Receiving tube feedings or parenteral nutrition (either total or partial) at the time of screening or randomization.
Any prior or current clinical diagnosis of heart failure, irrespective of left ventricular ejection fraction or New York Heart Association classification.
Trial design
Treatments tested in this trial
- ponsegromab
- placebo
Treatment groups
80 Participants
are divided into 2 treatment groupsLocations
This trial has no locations
Sponsors and collaborators
Pfizer
Lead sponsor
Source ClinicalTrials.gov