Ponsegromab for Muscle Loss and Weight Loss in Adults With Lung Cancer

Trial details

Who runs it

Pfizer

Trial code

NCT07663630EU 2026-526002-32-00

Record updated

25 September 2026

Original description

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.Read full original descriptionShow less

AN INTERVENTIONAL, PHASE 1B, DOUBLE-BLIND, RANDOMIZED, SPONSOR-OPEN, 2-ARM 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

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.

Inclusion: Signed Informed Consent; Documented histological or cytologic diagnosis of NSCLC with each of the following:; 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; no evidence of progression of disease following definitive, platinum-based, concurrent chemoradiation therapy; and; must be due to receive consolidation immunotherapy with durvalumab for up to 12 months, with the first dose of blinded study intervention to coincide with the first dose of durvalumab +/- 7 days; and; absence of actional genomic mutations (eg, EGFR, ALK); Cachexia defined by Fearon criteria:; BMI <20 kg/m2 and involuntary weight loss of >2% within 6 months prior to screening; or; Involuntary weight loss of >5% over the past 6 months prior to screening irrespective of BMI; Participant has been evaluated and determined that available anticachexic treatments have either been administered with no positive effect or the participant is not suitable for these treatments; Participants who are assessed by the investigator to have an ECOG PS ≤1.

Exclusion: 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; Clinically significant ascites that requires medical intervention or underwent a paracentesis within 4 weeks prior to randomization; Undergoing major surgery within 4 weeks prior to randomization or planned major surgical procedures during the study; Chronic use of systemic corticosteroid; Any Grade ≥3 pulmonary disease unrelated to underlying malignancy including, but not limited to:; Severe asthma requiring systemic corticosteroids within 30 days prior to first dose of study intervention or not well controlled with low-dose inhaled corticosteroids/long-acting beta-2 agonists; Severe chronic obstructive pulmonary disease requiring supplemental oxygen or systemic corticosteroids; Clinically severe and/or Grade 4 pulmonary emboli within 3 months of the first dose of study intervention. Pulmonary emboli in main or lobar pulmonary arteries are also excluded; Any autoimmune or inflammatory disorders with significant pulmonary parenchymal involvement at time of screening (ie, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc); Mixed small cell and non-small cell lung cancer histology; History of adrenal disorders (e.g. adrenal insufficiency, Cushing syndrome), pituitary adenoma or ectopic ACTH; History of any secondary malignancy in the last 2 years, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ; Symptomatic brain metastasis or leptomeningeal disease; Any prior or current clinical diagnosis of heart failure, irrespective of left ventricular ejection fraction or New York Heart Association classification; Renal disease requiring dialysis or eGFR <30 mL/min/1.73 m²; History of severe liver disease or cirrhosis, unrelated to metastatic cancer. LFT abnormalities at the time of screening; confirmed by a single repeat test if deemed necessary: AST or ALT level ≥ 3 x ULN (>5 x ULN if liver involvement by the tumor), or total bilirubin level ≥ 1.5 x ULN (For Gilbert's syndrome, direct bilirubin > ULN is exclusionary); Left ventricular ejection fraction <50% on screening echocardiogram (or MUGA scan); Current active reversible causes of decreased food intake, as determined by the investigator. These causes may include, but are not limited to:; NCI CTCAE Grade 3 or 4 oral mucositis; Mechanical obstructions interfering with the participant's ability to eat; Cachexia caused by reasons other than NSCLC, as determined by the investigator (eg, severe COPD).

ClinicalTrials.gov NCT07663630 · EU CTIS 2026-526002-32-00