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IrAEPhase 2JACKPOT22NCT07303881

Golidocitinib for Refractory Immune-related Hematologic Toxicities of Advanced Lung Cancer

A Phase 2 study testing golidocitinib in people with IrAE and Hematologic Disorder, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.

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

This study is a single-arm clinical trial designed to evaluate the safety and efficacy of golidocitinib in patients with refractory, immune-related hematologic toxicity in advanced lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
golidocitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteChina
Study dates
Feb 2026to Dec 2028
Phase
Phase 2
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

  • Able to provide a signed and dated informed consent form, including compliance with the Informed Consent Form (ICF) and the requirements and limitations listed in this protocol.
  • The subject is ≥18 years of age at the time of signing the ICF.
  • Has not experienced disease progression in the past two weeks and has a Eastern Cooperative Oncology Group (ECOG) score of 0-2, with a predicted survival of ≥12 weeks.
  • Pathologically or cytologically confirmed locally advanced (American Joint Committee on Cancer, AJCC 8th edition IIIB and IIIC stages) or metastatic (stage IV) non-small cell lung cancer, or extensive-stage small cell lung cancer (AJCC 8th edition TNM staging of lung cancer stage IV, or T3-4 disease caused by multiple pulmonary nodules with excessive disease spread, or tumor/nodule size too large for a tolerable radiation therapy plan).
  • Patients confirmed by an accredited local laboratory to lack any therapeutically targeted driver gene mutations, i.e., driver gene-negative subjects.
  • Patients experiencing grade ≥3 refractory hematologic toxicity (white blood cell count <2.0 × 10⁹/L or/and absolute neutrophil count <1.0 × 10⁹/L or/and platelet count <50 × 10⁹/L or/and hemoglobin <8.0 g/dL, specific hematologic parameters are detailed in Appendix D), during treatment with immune checkpoint inhibitors (including monotherapy or combination therapy), and the toxicity is considered to be immune-related. Refractory toxicity is defined in two main ways: ① Resistance to conventional treatment: No significant improvement in hematologic toxicity after at least 3 days of supportive care including the use of hormones (e.g., methylprednisolone ≥1 mg/kg/d), hematopoietic growth factors (e.g., G-CSF, TPO), and/or blood transfusions; ② Positive antinuclear antibody profile indicating anti-SSA antibodies and/or Ro52 antibodies, suggesting an immune-mediated mechanism.
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  • Patients with brain metastases must be asymptomatic or have been treated and have stable disease after discontinuation of steroids and anticonvulsants. Patients suspected of having brain metastases at screening should undergo brain CT/MRI before study enrollment.
  • At least one measurable lesion (as defined in RECIST 1.1): a lesion that has not undergone radiotherapy, has a long diameter ≥10 mm (short diameter ≥15 mm for lymph node lesions), and can be accurately and repeatedly measured from baseline on CT or MRI; and a measurable lesion outside the central nervous system.
  • Adequate organ system functional reserve, summarized as follows:
  • Total bilirubin ≤1.5×ULN; if Gilbert's syndrome (unconjugated hyperbilirubinemia) is present, total bilirubin should be ≤3×ULN.
  • ALT and AST ≤2.5×ULN. For patients with documented liver metastases, AST and ALT levels ≤5×ULN.
  • Creatinine clearance, calculated using the Cockcroft-Gault method, >60 ml/min for patients treated with cisplatin and >45 ml/min for patients treated with carboplatin.
  • Urinalysis shows less than 2+ protein in urine, or 24-hour urine protein quantification <1g.
  • Good coagulation function, defined as International Normalized Ratio (INR) and/or Prothrombin Time (PT) ≤1.5 times the ULN and/or Activated Partial Thromboplastin Time (APTT) ≤1.5 of the upper limit of normal; if the subject is receiving anticoagulation therapy, PT is acceptable as long as it is within the range intended for use with the anticoagulant.
  • Serum amylase ≤1.5 times the ULN and/or serum lipase ≤1.5 times the ULN.
  • Echocardiography (ECHO) shows a left ventricular ejection fraction (LVEF) ≥55%.
  • Women of Childbearing Potential (WOCBP) must undergo a urine and/or serum pregnancy test (if the urine test cannot confirm a negative result) within 7 days prior to the first dose of the study drug, and the result must be negative; WOCBP or male subjects and their WOCBP partners should agree to use effective contraception from the signing of the ICF until 6 months after the last dose of the study drug. k. Participants should be able to understand the study protocol and voluntarily comply with the study and follow-up.

Who cannot join

  • An active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying medications, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatment.
  • Prior to the first dose, any other form of immunosuppressive therapy other than corticosteroids (e.g., TNF-α inhibitors, mycophenolate mofetil, gamma globulin, rituximab, other JAK inhibitors, etc.) was received for hematologic toxicity.
  • Spinal cord compression or meningeal metastases are present. d. Any of the following medical histories:
  • Currently participating in an interventional clinical trial, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first dose; any drug still in development requires a 5-half-life washout (or discussion with the research team);
  • Underwent major surgery (excluding diagnostic or biopsy, excluding vascular access) within 4 weeks prior to the first dose, or is expected to undergo major surgery during the study;
  • Received palliative radiation therapy within 2 weeks prior to the first dose;
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  • Have experienced a serious arterial/venous thrombotic event within 6 months prior to the first dose, including cerebrovascular accidents (e.g., history of stroke or intracranial hemorrhage), deep vein thrombosis, and pulmonary embolism;
  • Currently receiving (or unable to discontinue at least 1 week prior to the first dose) any known potent inducer or inhibitor of CYP3A, herbal supplements, or foods;
  • Have experienced a grade CTCAE > 1 adverse event (excluding any degree of alopecia and hematologic toxicity) due to prior treatment prior to the first dose. e. Has received a solid organ or blood system transplant (e.g., a previous allogeneic bone marrow transplant).
  • Has a history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring corticosteroid therapy, or currently has active interstitial lung disease (including interstitial lung changes), or immune-mediated pneumonitis caused by immunotherapy.
  • Has been diagnosed with another malignancy within 5 years prior to the first dose, excluding clinically cured basal cell carcinoma, squamous cell carcinoma, and/or radically resected carcinoma in situ.
  • Has received a live vaccine, including attenuated live vaccines, excluding inactivated vaccines, within 30 days prior to the first dose.
  • Has known active tuberculosis, such as a positive tuberculin (PPD) test (induration diameter > 10 mm), a positive T-SPOT test, tuberculous lesions on chest X-ray/CT, or other positive results found according to routine clinical screening (excluding those cured by investigator assessment after standard anti-tuberculosis treatment).
  • Subjects with pre-existing, uncontrollable severe infectious diseases must be excluded. If an infectious disease occurred within two months prior to the first dose, its control must be assessed by the research team to determine eligibility for enrollment.
  • Subjects with active infections, including but not limited to hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) (see table below), and active COVID-19 infection (determined by the investigator to be clinically significant, with signs or symptoms). COVID-19 testing will be based on local practice.
  • Meeting any of the following cardiac criteria:
  • Congestive heart failure (CHF) classified as >II by the New York Heart Association (NYHA);
  • Clinically significant valvular heart disease, hypertrophic or constrictive cardiomyopathy;
  • Any clinically significant abnormality on resting ECG, such as complete left bundle branch block, second/third-degree atrioventricular block, or PR interval >250 msec;
  • Average calibrated QTcF >470 msec on three resting ECGs during the screening period;
  • Any factor that could increase the risk of QT interval prolongation or arrhythmic events (e.g., heart failure, hypokalemia, congenital long QT syndrome, or a first-degree relative with long QT syndrome or a family history of unexplained sudden death under 40 years of age, or any concomitant medication known to prolong the QT interval);
  • Ventricular arrhythmias requiring treatment;
  • An acute myocardial infarction (AMI), the onset of unstable angina, or a new onset of angina within 6 months prior to administration.
  • Hypersensitivity to the study drug or any component thereof. n. Intractable nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing medication, intestinal obstruction, or a history of bowel resection that may prevent adequate absorption of the study drug.
  • Pregnancy or lactation. p. Known bleeding diathesis, i.e., hemophilia or von Willebrand disease. q. Investigator assessment indicating a serious or uncontrolled systemic disease (including poorly controlled hypertension and bleeding disorders) that precludes participation in the clinical study or may lead to poor adherence.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wenhua Liang, MD, PhD contact

86-20-83337792

550627660@qq.com

China1 site

  • First Affiliated Hospital of Guangzhou Medical College

    Guangzhou, Guangdong

    Wenhua Liang, MD, PhD, 86-20-83337792, 550627660@qq.com

Other trials in China

About this study

Official title: A Clinical Study Evaluating the Safety and Efficacy of Golidocitinib in Patients With Refractory Immune-related Hematologic Toxicities of Advanced Lung Cancer

This study is a single-arm clinical trial designed to evaluate the safety and efficacy of golidocitinib in patients with refractory, immune-related hematologic toxicity in advanced lung cancer.

Read the detailed description

This is a single-center, single-arm clinical trial designed to evaluate the safety and efficacy of golixitinib in patients with advanced lung cancer exhibiting refractory immune-related hematologic toxicity. In this study, refractory immune-related hematologic toxicity was defined as grade ≥3 hematologic toxicity in patients with advanced lung cancer receiving immune checkpoint inhibitor therapy, unresponsive to treatment with hormones/hematopoietic factors/blood transfusions, and with a positive antinuclear antibody (ANA) profile (anti-SSA antibody). Patients with refractory immune-related hematologic toxicity will primarily receive golixitinib. This study comprises two parts:

Part A (dose escalation): This part will include patients with refractory immune-related hematologic toxicity to determine the safety and initial hematologic toxicity mitigation of golixitinib in this population, and to determine the recommended dose for Part B (dose extension).

Part B (dose extension): This part will include patients with refractory immune-related hematologic toxicity to further explore the hematologic toxicity mitigation and safety of the selected dose of golixitinib in this population.

Based on the BOIN dose escalation and Simon two-stage efficacy assessment design, if the dose of golixitinib used in Part B is 75 mg, the total number of subjects to be included in Parts A and B is 10; if the dose of golixitinib used in Part B is 150 mg, the total number of subjects to be included in Parts A and B is 13-16.

Being tested
golidocitinib
Keywords
Immune-related hematologic toxicities, irAE, Lung cancer
Medical subject headings
Hematologic Diseases, Lung Neoplasms, Neoplasm Metastasis

What participants receive

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

  • golidocitinibDrug

    Golidocitinib treatment can be discontinued once clinical remission is achieved, with a maximum maintenance period of 12 weeks.

Study groups in NCT07303881
Study groupRoleWhat they receive
golidocitinibExperimentalBased on the BOIN dose escalation and Simon two-stage efficacy assessment design, if the dose of golidocitinib used in Part B is 75 mg, the total number of subjects to be included in Parts A and B is 10; if the dose of golidocitinib used in Part B is 150 mg, the total number of subjects to be included in Parts A and B is 13-16.
Receives: Drug: golidocitinib

What is being measured

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

  1. Clinical remission rate of immune-related hematologic toxicities

    The proportion of subjects who achieved clinical remission of immune-related hematologic toxicities treated with golidocitinib (clinical remission is defined as a degraded hematologic toxicity grade within 1 week of golidocitinib use, a hematologic toxicity grade ≤1 within 2 weeks, and no relapse before discontinuation of treatment). This was assessed by the investigator based on laboratory indicators and the subject's clinical condition.

    Measured: 12 weeks

Secondary outcomes (4)

  1. Negative conversion rate of SSA/Ro52 antibody

    The proportion of subjects whose SSA/Ro52 antibody test results changed from positive to negative. This was assessed by the investigator based on laboratory indicators and the subjects' clinical condition.

    Measured: 12 weeks

  2. Progression free survival

    The duration from the start of immunotherapy to disease progression or death from any cause as determined by RECIST 1.1, regardless of whether the subject discontinued the investigational drug or received other anticancer treatments before disease progression. This assessment is conducted by the investigator based on the subject's imaging and clinical condition.

    Measured: 2 years

  3. Overall survival

    The time from the start of immunotherapy to the subject's death from any cause, regardless of whether the subject received other anticancer treatments. Assessed by the investigator based on the subject's clinical condition.

    Measured: 2 years

  4. Adverse events

    Incidence of adverse events/serious adverse events, severity as assessed by CTCAE v5.0, and relevance to the investigational drug.

    Measured: 12 weeks

Timeline

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

  1. First posted26 Dec 2025
  2. Study startFeb 2026 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionDec 2028 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07303881
Sponsor's protocol ID
ES-2025-244-02
Acronym
JACKPOT22
Status last verified
Dec 2025
First submitted
12 Dec 2025
Last updated
26 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data will be kept confidential before publication.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing golidocitinib in people with IrAE and Hematologic Disorder, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.

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 25 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 26 Dec 2025. 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 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Wenhua Liang, MD, PhD (86-20-83337792, 550627660@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical remission rate of immune-related hematologic toxicities (time frame: 12 weeks). 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 NCT07303881.

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 26 Dec 2025.

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