Ponsegromab for Cancer Cachexia in Lung Cancer

Not yet recruiting at 6 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Pfizer

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for adults with non-small cell lung cancer who have lost significant weight without trying, have a BMI under 20 or over 5% unintentional weight loss in the past 6 months. They must have finished chemo and radiation recently, show no new tumor growth, and be starting immunotherapy.

Inclusion Criteria

Cachexia defined by Fearon criteria: BMI <20 kg/m2 and involuntary weight loss >2% within 6 months prior to screening or involuntary weight loss >5% over past 6 months irrespective of BMI
Signed Informed Consent
My cancer has not worsened after platinum-based chemoradiation.
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Exclusion Criteria

Receiving tube feedings or ongoing clinical indication for parenteral nutrition at screening or randomization (short-term parenteral nutrition for acute transient indications allowed if discontinued prior to randomization)
I have had or will have major surgery within 4 weeks of starting the study.
I have been diagnosed with heart failure at any time.
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What Are the Treatments Tested in This Trial?

Interventions

  • Ponsegromab

Trial Overview

The study compares ponsegromab (an experimental drug) to a placebo to see if it helps improve muscle mass and physical function in people with lung cancer-related weight loss. Participants are randomly assigned to receive either ponsegromab or placebo.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Double-Blind ponsegromab Treatment doseExperimental Treatment1 Intervention
Group II: Double-Blind Placebo TreatmentPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials
4,712
Recruited
50,980,000+
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Vaccine Innovations
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Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University