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Non-small Cell Lung Cancer (NSCLC)Phase 1NCT07663630

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

A Phase 1 study testing ponsegromab in people with Non-small Cell Lung Cancer (NSCLC) and Cachexia, run by Pfizer at 7 sites in 2 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer (NSCLC), Cachexia
What is being tested?
ponsegromab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
7 sitesin 2 countries
Study dates
23 Oct 2026to 1 Jul 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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 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).
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  • 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:
  • 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).
  • 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).

Trial locations and contacts

7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

7 sites in 2 countries

United States6 sites

  • Cancer Care Specialists of Illinois-Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Dallas Cancer Specialists

    Garland, Texas, 75042

  • Houston Cancer Treatment Centers

    Houston, Texas, 77089

  • Lumi Research

    Houston, Texas, 77090

  • Cancer Care Specialists of Illinois - Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

Other trials in United States

China1 site

  • The Universityof Hong Kong-Shenzhen Hospital

    Shenzhen, Guangdong, 518053

Other trials in China

About this study

Official title: 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.

Read the detailed description

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.

Being tested
ponsegromab, placebo
Keywords
non-small cell lung cancer, cancer, anorexia, cachexia, weight loss, loss of appetite, fatigue
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Cachexia, Neoplasms, Anorexia, Weight Loss, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ponsegromabDrug

    Double-Blind ponsegromab Treatment

  • placeboDrug

    Double-Blind placebo Treatment

Study groups in NCT07663630
Study groupRoleWhat they receive
Double-Blind Placebo TreatmentPlacebo comparatorMatch placebo subcutaneous injection every 4 weeks
Receives: Drug: placebo
Double-Blind ponsegromab Treatment doseExperimentalPonsegromab 400 mg subcutaneous injection every 4 weeks
Receives: Drug: ponsegromab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent change from baseline in Lumbar Skeletal Muscle Index

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

    Measured: Baseline, Week 12

Secondary outcomes (5)

  1. Percent change from baseline in Lumbar Skeletal Muscle Index

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

    Measured: Baseline, Week 24

  2. Change from baseline in physical activity

    Measured by wearable Digital Health Technology watch

    Measured: Baseline, Week 12, Week 24

  3. Percent change from baseline in body weight

    Measured: Baseline, Week 12, Week 24

  4. Percent change from baseline in 24-hour urinary free cortisol, morning serum cortisol, plasma ACTH, and nighttime salivary cortisol

    Measured: Baseline, Week 12, Week 24

  5. Incidence of treatment-emergent adverse events

    Measured: Baseline, up to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2026
  2. Study start23 Oct 2026 (estimated)
  3. Primary completion6 May 2028 (estimated)
  4. Study completion1 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07663630
Sponsor's protocol ID
C3651034
Other IDs
2026-526002-32-00
Status last verified
Sep 2026
First submitted
17 Jun 2026
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ponsegromab in people with Non-small Cell Lung Cancer (NSCLC) and Cachexia, run by Pfizer at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change from baseline in Lumbar Skeletal Muscle Index (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07663630.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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