Could a cancer drug fight the wasting away seen in advanced lung cancer?

NCT ID NCT04906746

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This pilot study tests the drug ruxolitinib in people with advanced non-small cell lung cancer who are experiencing cancer cachexia—unintended weight loss and muscle wasting. The main goal is to check for side effects and see how the drug affects body signals related to appetite and muscle breakdown. Ten participants receive gradually increasing doses of ruxolitinib, and researchers measure changes in blood, fat, and muscle tissue.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ruxolitinib
What this could lead to
If successful, this could point toward a treatment for cancer-related weight loss and muscle wasting, improving quality of life.
What could go wrong
This is a very early, small pilot study with only 10 participants, so results may not apply broadly. Ruxolitinib can cause side effects like infections and blood cell changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

10 people

The number who actually took part.

Started

Feb 2022

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female subjects at least 18 years of age; 2. Ability to understand and the willingness to sign a written informed consent; 3. Histological or biopsy proven Non-Small Cell Lung Cancer (squamous or non-squamous); 4. ECOG performance status of 0-2; 5. Patients with evidence of: * cancer cachexia, defined by the International Cancer Cachexia Consensus Definition (\>5% weight loss over the preceding 6 months prior to diagnosis); OR * Patients with evidence of cancer pre-cachexia, defined by the International Cancer Cachexia Consensus Definition (0 to \<=5% weight loss over the preceding 6 months prior to diagnosis); 6. Any de novo stage IV NSCLC disease diagnosis as defined by AJCC 8th edition staging. Staged with PET/CT, MRI brain, or other acceptable staging tool; measurable disease as defined by RECIST 1.1; 7. Adequate end-organ function, based on routine clinical and laboratory workup and institutional guidelines, as determined by oncology team offering patient standard of care therapy, including: 1. ANC \>1,000 cells/µl, Platelets \> 100,000 cells/µl, Hemoglobin \> 10.0 g/dl; 2. Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 45 ml/min; 3. Total bilirubin ≤ 1.5 x ULN (or direct bilirubin below the ULN), AST and ALT ≤ 2.5 x ULN; 4. International normalized ratio (INR) (or prothrombin time (PT)) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy, if values are within the intended therapeutic range; 8. Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: a. Has not undergone a hysterectomy or bilateral oophorectomy; or b. Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months); 9. Male subjects who are surgically sterile or are using a medically acceptable form of contraception for 90 days following the completion of therapy; 10. Life expectancy anticipated to be 6 months or greater; 11. No prior therapy for advanced lung cancer. Exclusion Criteria: 1. Subjects with confirmed stage I-III NSCLC; 2. Patients whose tumors have actionable mutations treatable with targeted therapies; 3. Patients with no evidence of cancer cachexia, defined by the International Cancer Cachexia Consensus Definition (\>5% weight loss over the preceding 6 months prior to diagnosis); OR Patients with no evidence of cancer pre-cachexia, defined by the International Cancer Cachexia Consensus Definition (0 to \<=5% weight loss over the preceding 6 months prior to diagnosis); 4. Active malignancy other than lung cancer that requires concurrent treatment other than hormonal therapy and is deemed by the treating physicians to be likely to affect the subject's survival duration; 5. Subjects who have not recovered or have disease control from prior treatment-related to toxicities judged by treating physician; 6. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ruxolitinib or other agents used in study; 7. Uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements; 8. Inadequate liver or renal function, if out of the acceptable ranges of the inclusion criteria; 9. Significant bacterial, fungal, parasitic, or viral infection requiring treatment; 10. Previous treatment with a JAK inhibitor; 11. Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of ruxolitinib; 12. Females who are pregnant, breast-feeding or plan to become pregnant; 13. Participation in other clinical trials either to treat diagnosed lung or other cancers (patients on registry trials are eligible); 14. Requirement for treatment with drugs that may, in the judgment of the treating investigator, create a risk for a precipitous change in patient's health; 15. Any other conditions that, in the Investigator's opinion, might indicate the subject to be unsuitable for the study; 16. Life expectancy of less than 6 months; 17. Prior therapy for the newly diagnosed advanced lung cancer. 18. Patients taking therapies that are strong CYP3A4 inhibitors and fluconazole.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

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