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.
The primary purpose of this Phase 1b, double-blind, sponsor-open, randomized, 2-arm study to investigate the effect of study medicine (ponsegromab) compared to placebo (an injection that looks like the study medicine but does not contain the active medicine) on skeletal muscle mass, blood and urine-based assessments and physical function in adults with locally advanced, unresectable, Stage III non-small cell lung cancer and cachexia, who have completed chemoradiotherapy and are starting on consolidation therapy with an immune checkpoint inhibitor (durvalumab). The study will also assess the safety, tolerability, PK, PD, and immunogenicity of ponsegromab. Participants will not know which treatment group they are assigned. Participants in this study will equally receive either the study medicine (ponsegromab) or placebo by shots under the skin every four weeks. Participants will take part in this study for about 8 months. During this time participants will visit the study clinic once a month. Participants in this study may also be eligible to join an extra 1-year open-label extension period where everyone is administered ponsegromab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
80
Double-Blind ponsegromab Treatment
Double-Blind placebo Treatment
Percent change from baseline in Lumbar Skeletal Muscle Index
Assessed by computer tomography (CT) (or MRI \[magnetic resonance imaging\])
Time frame: Baseline, Week 12
Percent change from baseline in Lumbar Skeletal Muscle Index
Assessed by computer tomography (CT) (or MRI \[magnetic resonance imaging\])
Time frame: Baseline, Week 24
Change from baseline in physical activity
Measured by wearable Digital Health Technology watch
Time frame: Baseline, Week 12, Week 24
Percent change from baseline in body weight
Time frame: Baseline, Week 12, Week 24
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
Incidence of treatment-emergent adverse events
Time frame: Baseline, up to Week 24
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