Health TrialsbyHealthPanel

A Study to Learn About the Study Medicine Called Ponsegromab in Adults With Lung Cancer-Associated Significant Body Weight Loss

ConditionsNon-small Cell Lung Cancer (NSCLC)Cachexia
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

This trial does not accept healthy volunteers

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 having an ongoing clinical indication for parenteral nutrition (either total or partial) at the time of screening or randomization. Of note: short-term parenteral nutritional support for the management of acute, transient medical indications is allowed if discontinued prior to randomization.

Any prior or current clinical diagnosis of heart failure, irrespective of left ventricular ejection fraction or New York Heart Association classification.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ponsegromab

    Drug

    Double-Blind ponsegromab Treatment

  • placebo

    Drug

    Double-Blind placebo Treatment

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Double-Blind Placebo TreatmentPlacebo comparator 1 intervention
Group B: Double-Blind ponsegromab Treatment doseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percent change from baseline in Lumbar Skeletal Muscle Index

Assessed by computer tomography (CT) (or MRI \[magnetic resonance imaging\])

Time frame
Baseline, Week 12

Secondary outcomes

1

Percent change from baseline in Lumbar Skeletal Muscle Index

Assessed by computer tomography (CT) (or MRI \[magnetic resonance imaging\])

Time frame
Baseline, Week 24
2

Change from baseline in physical activity

Measured by wearable Digital Health Technology watch

Time frame
Baseline, Week 12, Week 24
3

Percent change from baseline in body weight

Time frame
Baseline, Week 12, Week 24
4

Percent change from baseline in 24-hour urinary free cortisol, morning serum cortisol, plasma ACTH, and nighttime salivary cortisol

Time frame
Baseline, Week 12, Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pfizer

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: