Pfizer
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 sa…
Key Inclusion Criteria: * Signed Informed Consent * Documented histological or cytologic diagnosis of NSCLC with each of the following: 1. 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 2. measurable disease at time of screening (assessment per RECIST v1.1); and 3. must have completed platinum-based chemotherapy concurrent with radiation therapy, within 7 to 42 days prior to the randomization; and 4. no evidence of progression of d…
Double-Blind ponsegromab Treatment
Double-Blind placebo Treatment