A Study to Learn About the Study Medicine Called Ponsegromab in Adults With Lung Cancer-Associated Significant Body Weight Loss
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 8 months
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants will take part in this study for about 8 months."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how ponsegromab affects muscle size and physical ability. It is for adults with non-small cell lung cancer and cachexia, which means major unwanted weight loss linked to cancer.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Sign a form agreeing to take part after learning about the study.
- Have confirmed stage III non-small cell lung cancer that cannot be removed by surgery and can be measured on scans. The cancer must not have certain gene changes, such as EGFR or ALK.
- Have finished platinum-based chemotherapy given with radiation 7 to 42 days before being assigned to a study group. The cancer must not have gotten worse after treatment.
- Plan to receive durvalumab, a medicine that helps the immune system fight cancer, for up to 12 months. Start the study medicine within 7 days before or after the first durvalumab dose.
- Have lost more than 5% of body weight without trying in the past 6 months, or have a BMI below 20 and have lost more than 2%. BMI compares weight with height.
- Have tried available treatments for cancer-related weight loss without benefit, or be unable to use them.
- Be fully active or able to walk and do light work, even if hard physical activity is limited.
Who can't join
- Have a treatable cause of eating less, such as severe mouth sores or a blockage. Receive tube feeding or need ongoing nutrition through a vein; short-term vein feeding must stop before study group assignment.
- Have weight loss caused by something other than non-small cell lung cancer, or have a mix of small cell and non-small cell lung cancer.
- Have ever had heart failure, or have a screening heart test showing that the heart pumps out less than 50% of its blood with each beat.
- Have belly fluid needing treatment, or have had it drained within 4 weeks before study group assignment. Have major surgery within those 4 weeks or plan major surgery during the study.
- Have a history of certain hormone disorders, including adrenal gland disorders, a pituitary gland tumor, or ACTH hormone made in the wrong place. Use steroid medicines that affect the whole body long term.
- Have had another cancer in the past 2 years, except certain fully treated skin cancers or cancers that stayed where they started. Have cancer spread to the brain causing symptoms, or to the lining around the brain and spinal cord.
- Have severe lung disease not caused by the cancer, including certain cases of asthma, chronic obstructive pulmonary disease (COPD), lung blood clots, or immune-related lung inflammation.
- Need dialysis or have very low kidney function. Have severe liver disease or liver scarring not caused by cancer spread, or liver blood tests above the study’s limits.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 disease following definitive, platinum-based, concurrent chemoradiation therapy; and 5. 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 6. absence of actional genomic mutations (eg, EGFR, ALK). * Cachexia defined by Fearon criteria: 1. BMI \<20 kg/m2 and involuntary weight loss of \>2% within 6 months prior to screening; or 2. 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. Key Exclusion Criteria: * Current active reversible causes of decreased food intake, as determined by the investigator. These causes may include, but are not limited to: 1. NCI CTCAE Grade 3 or 4 oral mucositis 2. 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. * Cachexia caused by reasons other than NSCLC, as determined by the investigator (eg, severe COPD). * Mixed small cell and non-small cell lung cancer histology. * 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. * History of adrenal disorders (e.g. adrenal insufficiency, Cushing syndrome), pituitary adenoma or ectopic ACTH. * Chronic use of systemic corticosteroid. * 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 Grade ≥3 pulmonary disease unrelated to underlying malignancy including, but not limited to: 1. 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. 2. Severe chronic obstructive pulmonary disease requiring supplemental oxygen or systemic corticosteroids. 3. 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. 4. Any autoimmune or inflammatory disorders with significant pulmonary parenchymal involvement at time of screening (ie, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc). * 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).
Study sites (6)
IL
- Cancer Care Specialists of Illinois-Decatur · Decatur, IL 62526More trials in Decatur
- Decatur Memorial Hospital · Decatur, IL 62526More trials in Decatur
- Cancer Care Specialists of Illinois - Cancer Care Center of O'Fallon · O'Fallon, IL 62269More trials in O'Fallon
TX
- Dallas Cancer Specialists · Garland, TX 75042More trials in Garland
- Houston Cancer Treatment Centers · Houston, TX 77089More trials in Houston
- Lumi Research · Houston, TX 77090More trials in Houston