Stage IV Non-small Cell Lung CancerEarly Phase 1NCT04906746

Ruxolitinib for Cancer Cachexia

A Early Phase 1 study testing Identify any dose-limiting toxicity (DLT) when ruxolitinib is administered to NSCLC cachexia patients. in people with Stage IV Non-small Cell Lung Cancer and Cachexia, run by Tu Dan at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

To assess toxicity with use of Ruxolitinib in NSCLC cachexia patients; to associate levels of JAK/STAT signaling in blood, adipose, and muscle pre- and post-ruxolitinib treatment with changes in cachexia and anorexia. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stage IV Non-small Cell Lung Cancer, Cachexia
What is being tested?: Identify any dose-limiting toxicity (DLT) when ruxolitinib is administered to NSCLC cachexia patients.
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 23 Feb 2022to Sep 2026
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Male or female subjects at least 18 years of age;
Ability to understand and the willingness to sign a written informed consent;
Histological or biopsy proven Non-Small Cell Lung Cancer (squamous or non-squamous);
ECOG performance status of 0-2;
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

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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);
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;
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:
ANC >1,000 cells/µl, Platelets > 100,000 cells/µl, Hemoglobin > 10.0 g/dl;
Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 45 ml/min;
Total bilirubin ≤ 1.5 x ULN (or direct bilirubin below the ULN), AST and ALT ≤ 2.5 x ULN;
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;
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);
Male subjects who are surgically sterile or are using a medically acceptable form of contraception for 90 days following the completion of therapy;
Life expectancy anticipated to be 6 months or greater;
No prior therapy for advanced lung cancer.

Who cannot join

Subjects with confirmed stage I-III NSCLC;
Patients whose tumors have actionable mutations treatable with targeted therapies;
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);
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;
Subjects who have not recovered or have disease control from prior treatment-related to toxicities judged by treating physician;
History of allergic reactions attributed to compounds of similar chemical or biologic composition to ruxolitinib or other agents used in study;

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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;
Inadequate liver or renal function, if out of the acceptable ranges of the inclusion criteria;
Significant bacterial, fungal, parasitic, or viral infection requiring treatment;
Previous treatment with a JAK inhibitor;
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;
Females who are pregnant, breast-feeding or plan to become pregnant;
Participation in other clinical trials either to treat diagnosed lung or other cancers (patients on registry trials are eligible);
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;
Any other conditions that, in the Investigator's opinion, might indicate the subject to be unsuitable for the study;
Life expectancy of less than 6 months;
Prior therapy for the newly diagnosed advanced lung cancer.
Patients taking therapies that are strong CYP3A4 inhibitors and fluconazole.

Trial locations and contacts

1 site in 1 country.

United States1 site

UT Southwestern Medical Center
Dallas, Texas, 75390

Other trials in United States

About this study

Official title: Pilot Study of Ruxolitinib in the Treatment of Cancer Cachexia

Read the detailed description

Lung cancer patients on a whole, and a significant percentage of NSCLC patients in particular, develop cancer cachexia. In fact, approximately 30-40% of all NSCLC patients will develop cachexia in their disease course, with the highest percentages in stage IV patients. One-third of these patients will die of cachexia-related morbidity. In these groups, stage-matched NSCLC patients with cachexia will have poorer survival than those without cachexia.

The JAK 1/2 inhibitor ruxolitinib has been used in many types of non-oncologic and oncologic patients with a well-established toxicity profile. Ruxolitinib was created as an oral agent with the capacity to antagonize JAK/STAT signaling across cell types. Based on the findings of the REACH2 and REACH3 trials, a starting dose of 10 mg twice daily oral administration of ruxolitinib was established for the latter patient population and is also a starting dose for the polycythemia patients. Known but manageable side effects of ruxolitinib use include thrombocytopenia, anemia, neutropenia, risk of infection, among other conditions.

Ruxolitinib has not specifically been used in 1) cancer cachexia patient populations in an evaluable trial or 2) in the setting of first line cancer therapies for solid tumors who are receiving new standards of care including immunotherapy (IO). Therefore, in this trial, investigators propose using ruxolitinib in an open-label approach to antagonize systemic and tissue-specific, tumor-directed JAK/STAT signaling as a means curtailing cachexia progression in stage IV NSCLC patients. This study will ensure an acceptable toxicity profile when ruxolitinib is used in cancer cachexia patients.The use of ruxolitinib dose escalation in the same patients with frequent tissue and serum collections will permit us to better understand how important JAK/STAT signaling is to clinical cancer cachexia development.

Conditions: Stage IV Non-small Cell Lung Cancer, Cachexia
Being tested: Identify any dose-limiting toxicity (DLT) when ruxolitinib is administered to NSCLC cachexia patients.
Keywords: Lung cancer, Anorexia, Metabolism, Adipose, Muscle wasting
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Cachexia, Lung Neoplasms, Anorexia, Muscular Atrophy

What participants receive

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

Identify any dose-limiting toxicity (DLT) when ruxolitinib is administered to NSCLC cachexia patients.Drug
There will be intra-patient dose escalation of ruxolitinib in every patient enrolled on study.

Study groups in NCT04906746
Study group	Role	What they receive
Dosing Regimen for Ruxolitinib	Experimental	Level 0: Ruxolitinib 0 MG po bid for 1 month (Month 1) Level 1: Ruxolitinib 10 MG po bid for 1 month (Month 2) Level 2: Ruxolitinib 15 MG po bid for 1 month (Month 3) Receives: Drug: Identify any dose-limiting toxicity (DLT) when ruxolitinib is administered to NSCLC cachexia patients.

What is being measured

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

Number of Non-small Cell Lung Cancer Cachexia Patients With Toxicity With the Use of Ruxolitinib
To assess toxicity with use of Ruxolitinib in NSCLC (non-small cell lung cancer) cachexia patients, NCI's CTCAE v5.0 toxicity criteria will be used to measure Ruxolitinib-related side effects. Grade 3 or higher events will be recorded.
Measured: 3 months
Analysis of Any Preliminary Evidence Suggesting That Ruxolitinib Suppresses Adipose and Lean Muscle Loss in Cancer Cachexia Patients
Body weight will be measured every 2 weeks while on study, including 1 month of follow-up. Both DEXA (dual-energy x-ray absorptiometry) imaging every 2 weeks while on study/follow-up and CT-based imaging with auto-segmentation will provide measures of how Ruxolitinib may be suppressing cachexia-associated adipose and muscle loss.
Measured: 4 months
Analysis of Any Preliminary Evidence Suggesting That Ruxolitinib Suppresses Anorexia in Cancer Cachexia Patients.
Anorexia will be assessed with the EORTC QLQ-CAX24 questionnaire as well as direct clinical history taking every 2 weeks on study. Descriptive statistics will be used to report changes.
Measured: 4 months

Secondary outcomes (5)

Number of Adverse Events Associated With Ruxolitinib When Administered to Cancer Cachexia Patients
For the secondary objective of overall adverse event assessment, the investigator will again use NCI's CTCAE v5.0 toxicity criteria throughout the trial evaluation. All events, regardless of grade, will be recorded.
Measured: 3 months
Number of Participants With Objective Response (OR) as Determined by RECIST Criteria
Patient tumor response will be determined by CT-based imaging (CT, PET/CT), MRI (brain evaluation), and other clinical indicators (bronchoscopy, image-guided biopsies), etc. with RECIST and/or iRECIST criteria response criteria as a function of Ruxolitinib use and dose. In patients with measurable disease, preliminary evidence of Ruxolitinib's anti-tumor activity by assessment of objective response as determined by RECIST in cancer cachexia patients will be used. Two such measurements will be conducted during the course of the trial. iRECIST criteria will be utilized as needed for unconfirmed cases of progression when applicable.
Measured: 3 months
Analysis Providing Any Preliminary Evidence That Ruxolitinib Improves Quality of Life (QoL) for Cancer Cachexia Patients
Quality of life questionnaires while on ruxolitinib will be assessed with the EORTC QLQ-CAX24 (The European Organization for Research and Treatment of Cancer quality of life questionnaire). Questionnaire was given to patients every 2 weeks for 3 months while on study treatment and at 1 month follow-up.
Measured: 4 months
Suppression of Body Weight Loss in Cancer Cachexia Patients
To describe any preliminary evidence suggesting that Ruxolitinib suppresses body weight loss in cancer cachexia patients. Body weight will be measured every 2 weeks while on study, including 1 month of follow-up, to provide measures of how Ruxolitinib may be suppressing cachexia-associated body weight loss.
Measured: 4 months
Analysis of Any Preliminary Evidence Suggesting That Ruxolitinib Improves Overall Survival in Cancer Cachexia Patients.
Overall survival (OS) will be assessed for all patients while on and off Ruxolitinib. There will be one determination of OS at 6 months from start of active phase of study. Estimates will be descriptively presented using the Kaplan-Meier method.
Measured: 6 months

Timeline

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

23 Feb 2022Sep 2026

First posted28 May 2021
Study start23 Feb 2022
Primary completion27 Sep 2024
Study completionSep 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Stage IV Non-small Cell Lung CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Open label, single arm, pilot study, Intrapatient dose escalation
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04906746
Sponsor's protocol ID: STU-2021-0475
Status last verified: May 2026
First submitted: 13 May 2021
Last updated: 7 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study of Ruxolitinib in the Treatment of Cancer Cachexia
ClinicalTrials.gov ID: NCT04906746
Acronym / sponsor ID: STU-2021-0475
Conditions: Stage IV Non-small Cell Lung Cancer, Cachexia
Keywords: Lung cancer, Anorexia, Metabolism, Adipose, Muscle wasting
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 10 participants (actual)
Lead sponsor: Tu DanUniversity, hospital or other
Collaborators: Incyte Corporation
Study start: 23 Feb 2022 (actual)
Primary completion: 27 Sep 2024 (actual)
Study completion: Sep 2026 (estimated)
First posted: 28 May 2021 (actual)
Results: Posted 7 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Open label, single arm, pilot study, Intrapatient dose escalation

Arm	Type	Receives
Dosing Regimen for Ruxolitinib	Experimental	Drug: Identify any dose-limiting toxicity (DLT) when ruxolitinib is administered to NSCLC cachexia patients.Level 0: Ruxolitinib 0 MG po bid for 1 month (Month 1) Level 1: Ruxolitinib 10 MG po bid for 1 month (Month 2) Level 2: Ruxolitinib 15 MG po bid for 1 month (Month 3)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Male or female subjects at least 18 years of age;
Ability to understand and the willingness to sign a written informed consent;
Histological or biopsy proven Non-Small Cell Lung Cancer (squamous or non-squamous);
ECOG performance status of 0-2;
Patients with evidence of:

Key exclusion criteria (18 listed)

Subjects with confirmed stage I-III NSCLC;
Patients whose tumors have actionable mutations treatable with targeted therapies;
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);
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;
Subjects who have not recovered or have disease control from prior treatment-related to toxicities judged by treating physician;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Identify any dose-limiting toxicity (DLT) when ruxolitinib is administered to NSCLC cachexia patients.There will be intra-patient dose escalation of ruxolitinib in every patient enrolled on study.	Drug	Dosing Regimen for Ruxolitinib

Primary outcome

Number of Non-small Cell Lung Cancer Cachexia Patients With Toxicity With the Use of Ruxolitinib
Time frame: 3 months
To assess toxicity with use of Ruxolitinib in NSCLC (non-small cell lung cancer) cachexia patients, NCI's CTCAE v5.0 toxicity criteria will be used to measure Ruxolitinib-related side effects. Grade 3 or higher events will be recorded.
Analysis of Any Preliminary Evidence Suggesting That Ruxolitinib Suppresses Adipose and Lean Muscle Loss in Cancer Cachexia Patients
Time frame: 4 months
Body weight will be measured every 2 weeks while on study, including 1 month of follow-up. Both DEXA (dual-energy x-ray absorptiometry) imaging every 2 weeks while on study/follow-up and CT-based imaging with auto-segmentation will provide measures of how Ruxolitinib may be suppressing cachexia-associated adipose and muscle loss.
Analysis of Any Preliminary Evidence Suggesting That Ruxolitinib Suppresses Anorexia in Cancer Cachexia Patients.
Time frame: 4 months
Anorexia will be assessed with the EORTC QLQ-CAX24 questionnaire as well as direct clinical history taking every 2 weeks on study. Descriptive statistics will be used to report changes.

5 secondary outcomes

Number of Adverse Events Associated With Ruxolitinib When Administered to Cancer Cachexia Patients
Time frame: 3 months
Number of Participants With Objective Response (OR) as Determined by RECIST Criteria
Time frame: 3 months
Analysis Providing Any Preliminary Evidence That Ruxolitinib Improves Quality of Life (QoL) for Cancer Cachexia Patients
Time frame: 4 months
Suppression of Body Weight Loss in Cancer Cachexia Patients
Time frame: 4 months
Analysis of Any Preliminary Evidence Suggesting That Ruxolitinib Improves Overall Survival in Cancer Cachexia Patients.
Time frame: 6 months

Results and safety

Results posted to the registry on 7 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Received Ruxolitinib	10	6

Primary outcome: Number of Non-small Cell Lung Cancer Cachexia Patients With Toxicity With the Use of Ruxolitinib

Time frame: 3 months. Count of participants. Unit: Participants

Measure	Ruxolitinib 10mg n = 2	Ruxolitinimb 15mg n = 2
Participants with Grade 3 or higher SAE possibly, probably, or definitely related to Ruxolitinib	0	0
Participants with Grade 3 or higher SAE unrelated to Ruxolitinib	0	0
Participants with no SAE	2	2

Population analysed: 2 Participants received at least one dose of 10 mg BID Ruxolitinib and proceeded to receive at least one dose of 15 mg BID Ruxolitinib. All patients enrolled were included in the Ruxolitinib 0mg group, which was not assessed for outcomes because of its baseline status, and is not included in this table.

Primary outcome: Number of Non-small Cell Lung Cancer Cachexia Patients With Toxicity With the Use of Ruxolitinib

Time frame: 3 months. Count of participants. Unit: Participants

Measure	Intervention Arm- Received Ruxolitinib n = 2
10mg Ruxolitinib Group	0
15mg Ruxolitinib Group	0

Primary outcome: Analysis of Any Preliminary Evidence Suggesting That Ruxolitinib Suppresses Adipose and Lean Muscle Loss in Cancer Cachexia Patients

Time frame: 4 months. Count of participants. Unit: Participants

Measure	10 mg Ruxolitinib n = 2	15mg Ruxolitinib n = 2
Protection of fat and lean mass observed	2	2
No protection of fat and lean mass observed	0	0

Population analysed: 2 participants agreed to DEXA scans and completed both the 10mg and 15mg Ruxolitinib arms. All patients enrolled were included in the Ruxolitinib 0mg group, which was not assessed for outcomes because of its baseline status, and is not included in this table.

Primary outcome: Analysis of Any Preliminary Evidence Suggesting That Ruxolitinib Suppresses Anorexia in Cancer Cachexia Patients.

Time frame: 4 months. Count of participants. Unit: Participants

Measure	10mg Ruxolitinib n = 2	15mg Ruxolitinib n = 2
EORTC QLQ-CAX24 score improved while on treatment	0	0
EORTC QLQ-CAX24 score did not improve while on treatment	2	2

Population analysed: 2 participants received at least one dose of 10 mg Ruxolitinib and proceeded to receive at least one dose of 15 mg Ruxolitinib. All patients enrolled were included in the Ruxolitinib 0mg group, which was not assessed for outcomes because of its baseline status, and is not included in this table.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of treatment phase start through discontinuation of treatment plus 1 month, up to 6 months total.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ruxolitinib 0mg	2 of 8 (25%)	8 of 8 (100%)	2 of 8
Ruxolitinib 10mg	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Ruxolitinib 15mg	0 of 2 (0%)	2 of 2 (100%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tu Dan, MD principal investigator

University of Texas Southwestern Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 17 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Non-small Cell Lung Cancer Cachexia Patients With Toxicity With the Use of Ruxolitinib (time frame: 3 months). The study lists 3 primary outcomes in all. 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 NCT04906746.

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 7 Jul 2026.