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AzTrials

Non-Small Cell Lung CancerPhase 2NCT06925048

SHR0302 Combined With PD-1/PD-L1 Inhibition for Treatment naïve or Acquired Resistant to Immunology NSCLC

A Phase 2 study testing PD-1 inhbitor+SHR0302 and PD-L1 inhibitor+SHR0302 in people with Non-Small Cell Lung Cancer and JAK Inhibitor, run by Chunxia Su.

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

Recent studies showed that the dysregulated activation of the JAK/STAT pathway, which leads to the prolonged release of IFN-γ, is a significant contributor to the resistance to immune checkpoint inhibitors in cancer immunotherapy. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
PD-1 inhbitor+SHR0302 and PD-L1 inhibitor+SHR0302
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
No sites listed yet
Study dates
30 Apr 2025to 31 Dec 2027
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Inoperable or non-suitable for radical radiotherapy and chemotherapy IIIB/IIIC and Stage IV or metastatic non-small cell lung cancer (NSCLC)
  • Provide written informed consent for the trial.
  • Patients ≥ 18 years of age
  • Arm 1: treatment naive; Arm 2: acquired resistant to first-line PD-1/PD-L1 inhibition. Acquired resistance is defined as documented initial objective response (partial or complete response by RECIST or WHO) to therapy or significant and durable (> 6 months) clinical benefit (stable disease defined by RECIST or WHO).
  • Subject must have adequate tumor burden at a safely accessible site for biopsy.
  • At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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  • ECOG performance status 0 or 1
  • Adequate organ function:
  • White Blood Cell ≥3.0×109/L; Absolute neutrophil count (ANC) ≥ 1.5×10*9 /L; Platelets ≥ 100×10*9 /L; Hemoglobin ≥ 9g/dl; (2) Serum creatinine ≤1.5 X upper limit of normal or creatinine clearance ≥ 40 mL/min; (3) Serum total bilirubin ≤ 1.5 X ULN; AST and ALT ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases; 9. Subjects of reproductive potential must agree to use acceptable birth control methods

Who cannot join

  • Non-small cell cancer contains components of small cell lung cancer or neuroendocrine carcinoma.
  • Sensitizing mutations in Epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) or ROS1 proto-oncogene receptor tyrosine kinase (ROS1) translocations;
  • Arm 1: Currently participating in or has participated in a study of an investigational agent or anticipated use of an investigational device within 4 weeks of the first dose of study treatment.
  • Receiving Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects within 2 weeks before the first administration.
  • Having a history of allergic reaction to any component of the study drug.
  • Having active hemoptysis requiring clinical intervention, active diverticulitis, abdominal abscess, gastrointestinal obstruction, and peritoneal metastasis.
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  • Having clinically uncontrollable pleural effusion/abdominal effusion (patients who do not need to drain the effusion or whose effusion does not increase significantly within 3 days after stopping drainage can be enrolled).
  • The tumor compressing surrounding vital organs (such as the esophagus) and accompanied by related symptoms, compressing the superior vena cava or invading the large vessels in the mediastinum, the heart, etc.
  • Severe comorbidities such as a history of severe lung or heart diseases, and having experienced any arterial thrombosis, embolism, or ischemia within 6 months before being selected for treatment, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack, etc.
  • Having a history of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolism within 3 months before enrollment.
  • Interstitial pneumonia (ILD), drug-induced pneumonia, radiation pneumonia requiring steroid treatment, or symptomatic active pneumonia.
  • Receiving systemic corticosteroids (>10 mg/d prednisone equivalent drugs) or other systemic immunosuppressants within 2 weeks before enrollment. Local, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids are allowed.
  • A history of autoimmune diseases. Patients with autoimmune-related hypothyroidism who are receiving a stable dose of thyroid hormone replacement therapy are eligible to participate in this study. Patients with type 1 diabetes mellitus who are under control after receiving a stable insulin treatment regimen are eligible to participate in this study.
  • Active systemic infection, including tuberculosis (clinical diagnosis includes clinical history, physical examination, and imaging findings, as well as TB examinations according to local medical routines), hepatitis B (known to be positive for HBV surface antigen (HBsAg) and HBV DNA ≥1000 cps/ml or the lower limit of its reference value), hepatitis C, or human immunodeficiency virus (positive for HIV antibody).
  • Known presence of mental illness or drug abuse that may affect compliance with the requirements of the trial.
  • Recently receiving sufficient oral or non-oral anticoagulants or thrombolytics. Prophylactic use of anticoagulants is allowed.
  • Having a medical history, disease, treatment, or laboratory abnormal results that may interfere with the trial results or prevent the subject from participating in the study throughout the whole process, or the investigator deems that participating in the study is not in the best interest of the subject.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Chunxia Su contact

021-65115006

susu_mail@126.com

About this study

Official title: A Multi-cohort, Phase II Study of SHR0302 Combined With PD-1/PD-L1 Inhibition for Treatment naïve or Acquired Resistant to Immunology NSCLC

Recent studies showed that the dysregulated activation of the JAK/STAT pathway, which leads to the prolonged release of IFN-γ, is a significant contributor to the resistance to immune checkpoint inhibitors in cancer immunotherapy. Preclinical and clinical studies have demonstrated that the combination of JAK inhibitors with PD-1 immunotherapy can reverse or delay onset of immunotherapy resistance by modulating the JAK/STAT pathway in Hodgkin's lymphoma and non - small cell lung cancer (NSCLC). SHR0302, being a highly selective JAK1 inhibitor, has shown excellent clinical benefits by effectively inhibiting the JAK/STAT pathway, leading to its approval for the treatment of Ankylosing Spondylitis in China. Preclinical studies also show that the combination of SHR0302 and PD-L1 inhibitor has synergistic potentials for anti-tumor effect in resistant to-immune checkpoint blockade patients. Thus, we conducted a phase 2 clinical trial evaluating SHR0302 combined with PD1/PD-L1 inhibitors as treatment-naïve or acquired resistant to first-line checkpoint inhibitor resistant NSCLC patients.

Being tested
PD-1 inhbitor+SHR0302, PD-L1 inhibitor+SHR0302
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • PD-1 inhbitor+SHR0302Drug

    PD-1 inhbitor+SHR0302 in the maintenance treatment

  • PD-L1 inhibitor+SHR0302Drug

    PD-L1 inhibitor+SHR0302 in second line

Study groups in NCT06925048
Study groupRoleWhat they receive
Arm1- maintenance treatmentExperimentalPD-1 inhibitor in combination with JAK inhibitor in the maintenance treatment
Receives: Drug: PD-1 inhbitor+SHR0302
Arm2-Second line after first-line immunotherapy resistanceExperimentalPD-L1 inhibitor in combination with JAK inhibitor in the second line
Receives: Drug: PD-L1 inhibitor+SHR0302

What is being measured

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

  1. Progression-free survival

    PFS is defined as days from initiation of study therapy to first documented disease progression, death due to any cause or last subject contact which documents progression-free status.

    Measured: through study completion, an average of 18 months

Secondary outcomes (3)

  1. Objective response rate

    Measured: percentage of evaluable subjects who achieve a complete or partial clinical response at 12 weeks

  2. Duration of Response

    DOR is defined as the time from first documentation of partial or complete response to first documented disease progression.

    Measured: through study completion, an average of 18 months

  3. Overall survival

    OS is defined as days from initiation of study therapy to death due to any cause or last subject contact.

    Measured: through study completion, an average of 18 months

Timeline

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

  1. First posted13 Apr 2025
  2. Study start30 Apr 2025 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06925048
Sponsor's protocol ID
2024LY1179
Status last verified
Mar 2025
First submitted
30 Mar 2025
Last updated
13 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PD-1 inhbitor+SHR0302 and PD-L1 inhibitor+SHR0302 in people with Non-Small Cell Lung Cancer and JAK Inhibitor, run by Chunxia Su.

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 9 inclusion and 17 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 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

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 Chunxia Su (021-65115006, susu_mail@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: through study completion, an average of 18 months). 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 NCT06925048.

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 13 Apr 2025.

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