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

NCT07663630 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: C36510342026-526002-32-00
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer (NSCLC); Cachexia

Keywords

non-small cell lung cancer, cancer, anorexia, cachexia, weight loss, loss of appetite, fatigue

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline in Lumbar Skeletal Muscle Index

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

  Baseline, Week 12

Secondary Outcomes (5)

• Percent change from baseline in Lumbar Skeletal Muscle Index

  Baseline, Week 24

• Change from baseline in physical activity

  Baseline, Week 12

• Change from baseline in 6-Minute Walk Distance

  Baseline, Week 12

• Percent change from baseline in body weight

  Baseline, Week 12, Week 24

• Incidence of treatment-emergent adverse events

  Baseline, up to Week 24

Study Arms (2)

Double-Blind ponsegromab Treatment dose

EXPERIMENTAL

Ponsegromab 400 mg subcutaneous injection every 4 weeks

Drug: ponsegromab

Double-Blind Placebo Treatment

PLACEBO COMPARATOR

Match placebo subcutaneous injection every 4 weeks

Drug: placebo

Interventions

ponsegromab DRUG

Double-Blind ponsegromab Treatment

Double-Blind ponsegromab Treatment dose

placebo DRUG

Double-Blind placebo Treatment

Double-Blind Placebo Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Receiving tube feedings or parenteral nutrition (either total or partial) at the time of screening or 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.
• Undergoing major surgery within 4 weeks prior to randomization or planned major surgical procedures during the study.
• History of immune-related adverse event(s) in setting of immunotherapy that required treatment with systemic corticosteroids.
• 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:
• 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.

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Cachexia; Neoplasms; Anorexia; Weight Loss; Fatigue

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Signs and Symptoms, Digestive

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start: July 22, 2026
• Primary Completion (Estimated): February 2, 2028
• Study Completion (Estimated): March 29, 2029
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share