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NSCLC (Advanced Non-small Cell Lung Cancer)Phase 1NCT06969612

A Study on the Efficacy and Safety of Golidocitinib Combined With Tislelizumab and Chemotherapy as First-line Treatment for Advanced NSCLC

A Phase 1 study testing Tislelizumab, Pemetrexed and Cisplatin in people with NSCLC (Advanced Non-small Cell Lung Cancer), run by Peking University Cancer Hospital & Institute at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn if golidocitinib combined with tislelizumab and chemotherapy works in advanced NSCLC with PD-L1≥1%. The main question it aims to answer is: Does the combination of golidocitinib with tislelizumab and chemotherapy can prolong the progression-free survival of patients with… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tislelizumab, Pemetrexed and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteChina
Study dates
15 May 2025to May 2028
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

  • Be able to provide the informed consent form with signatures and signing dates, including compliance with the requirements and restrictions listed in the informed consent Form (ICF) and this protocol;
  • At the time of signing the ICF, the age must be at least 18 years old, with no gender restrictions.
  • The ECOG score is 0 or 1.
  • Life expectancy ≥ 3 months;
  • Histological or cytological examination confirms that the newly diagnosed NSCLC is locally advanced (IIIB/C) or metastatic (stage IV) that cannot undergo radical surgery or radiotherapy;
  • PD-L1(22C3) ≥1%;
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  • At least one measurable lesion (RECIST v1.1);
  • The bone marrow reserve and organ system functional reserve are sufficient, which can be summarized as follows:
  • Under the condition of not receiving growth factor support, the absolute neutrophil count (ANC) was ≥ 1.5×109/L.
  • Under the condition of not receiving growth factor support or blood transfusion, platelet count ≥ 100×109/L.
  • In the absence of blood transfusion or reception of erythropoietin, hemoglobin ≥ 9 g/dL.
  • -Total bilirubin ≤ 1.5 × ULN; If one has Gilbert syndrome (unconjured hyperbilirubinemia), the total bilirubin should be ≤ 3 × ULN.
  • -ALT and AST≤ 2.5 × ULN. For patients with recorded liver metastases, the levels of AST and ALT are ≤ 5 × ULN.
  • -Blood creatinine ≤ 1.5 × ULN, or creatinine clearance rate calculated by the Cockcroft-Gault method ≥ 50 mL/min, or urine creatinine clearance rate measured within 24 hours ≥ 50 mL/min.
  • For patients with central nervous system metastases, the following conditions must be met before they can be enrolled:
  • No neurological symptoms or stable symptoms for at least 2 weeks after local treatment, no need to use corticosteroids or antiepileptic drugs, and hormone therapy should be discontinued within 3 days before the administration of the first study drug;
  • If the brain metastases have received local treatment (radiotherapy or surgery), there should be a time window of ≥2 weeks before the first administration of the study treatment to ensure that the adverse events related to local treatment have been reduced to CTCAE ≤ grade 1.
  • Women of Childbearing Potential (WOCBP) must undergo a urine and/or serum (if the urine test cannot be confirmed as negative) pregnancy test within 7 days before the first medication, and the result must be negative; WOCBP or the male and his WOCBP partner should agree to take effective contraceptive measures from the date of signing the ICF until 6 months after using the last dose of the study drug.

Who cannot join

  • Histology of lung adenocarcinoma confirmed the presence of EGFR19 deletion or L858R mutation and ALK, ROS-1 fusion gene mutation (non-adenocarcinoma patients are not required to undergo mandatory genetic testing).
  • Have received systemic chemotherapy, biological therapy, targeted therapy or immunotherapy for metastatic or advanced NSCLC before;
  • Interstitial pneumonia/immune pneumonia or interstitial changes are known to exist;
  • Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active CNS metastases;
  • Have any of the following medical histories:
  • Currently participating in intervention clinical research and treatment, any drug still in the research and development stage needs to be eluted for 5 half-lives (or discussed with the research team);
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  • Palliative radiotherapy has been received within 2 weeks before the first administration. Radiotherapy for more than 30% of the bone marrow or extensive radiotherapy needs to be completed within 4 weeks before administration.
  • Currently receiving (or unable to discontinue use at least one week before the first administration) drugs, herbal supplements, and foods that are known to be potent inducers or potent inhibitors of CYP3A Before the first administration, there were adverse events of CTCAE > grade 1 caused by the previous treatment (except for any degree of alopecia);
  • Have received solid organ or blood system transplants (such as having received allogeneic bone marrow transplants in the past or having received whole blood transfusions within 120 days of sample collection during the study period);
  • Subjects with severe pulmonary function decline (i.e., any FEV1 or DLCO < 60% of the predicted value). Previous interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid hormone therapy, current interstitial lung disease with active clinical symptoms (including interstitial changes in the lungs), immune pneumonia of grade 3 or above caused by immunotherapy, or treatment termination;
  • There is an active autoimmune disease that requires systemic treatment (such as the use of disease-relieving drugs, corticosteroids or immunosuppressants) within 2 years prior to the first administration. Alternative therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) are not regarded as systemic treatment;
  • Diagnosed with immune deficiency or undergoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to the first administration of the study, the use of physiological doses of glucocorticoids (≤10 mg/ day prednisone or equivalent drugs) is permitted;
  • Diagnosed with other malignant tumors within 5 years prior to the first administration, excluding cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma and/or carcinoma in situ that has been evaluated as clinically cured;
  • Live vaccines, including attenuated live vaccines, have been administered within 30 days before the first administration (day 1 of Cycle 1), except for inactivated vaccines.
  • The researchers judged it as active tuberculosis, such as a positive tuberculin (PPD) test (induration diameter > 10 mm), a positive T-SPOT test, tuberculosis foci found on chest X-ray plain film /CT, or other positive results found based on clinical routine screening (except for those who have recovered after standardized anti-tuberculosis treatment as evaluated by the researchers);
  • Subjects with active infections, including but not limited to hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV); 1) Active HCV and HIV infection, that is, the corresponding antibody test result is positive; 2) Untreated active hepatitis B, defined as HBsAg positive with HBV DNA ≥1000IU/ml, or HBcAb positive with HBV DNA ≥1000IU/ml; However, research participants who meet the following conditions can also be enrolled: Before the first administration, if HBsAg was positive and HBV DNA was < 1000IU/ml, the study participants should receive anti-HBV treatment throughout the study treatment period to prevent viral reactivation.
  • 13. For those with negative HBsAg, positive HBcAb and HBV DNA < 1000IU/ml, the participants of the study should have HBV DNA tested throughout the treatment period of the study.
  • 14. Allergy to the drugs used in the research or their components; 15. Dysphagia, or suffering from active digestive system diseases, or having undergone major digestive tract surgeries, which may significantly affect the administration or absorption of the investigational drug (such as ulcerative lesions, inability to swallow drugs, uncontrollable nausea, vomiting, diarrhea and malabsorption syndrome); 16. Those that the researcher deems unsuitable to participate in this study.

Trial locations and contacts

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

Minglei Zhuo contact

+86 88196456

reyiza1993@126.com

China1 site, 1 recruiting

  • Peking University Cancer Hospital & Institute

    Beijing, Beijing Municipality, 100142

    Minglei Zhuo, +86 88196456, reyiza1993@126.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Phase IB Clinical Study on the Efficacy and Safety of Golidocitinib Combined With Tislelizumab and Chemotherapy as First-line Treatment for Advanced NSCLC

The goal of this clinical trial is to learn if golidocitinib combined with tislelizumab and chemotherapy works in advanced NSCLC with PD-L1≥1%. The main question it aims to answer is:

Does the combination of golidocitinib with tislelizumab and chemotherapy can prolong the progression-free survival of patients with advanced NSCLC?

Participants will： Take tislelizumab and chemotherapy for 2 cycles; and then take tislelizumab and golidocitinib for 2 cycles; after cycle 5, patients receive tislelizumab and chemotherapy until the patients were intolerant or the disease progressed.

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.

  • TislelizumabDrug

    200 mg, intravenously on Day 1, every 3 weeks

  • PemetrexedDrug

    administered via IV infusion

  • CisplatinDrug

    administered via IV infusion

  • CarboplatinDrug

    administered via IV infusion

  • PaclitaxelDrug

    administered via IV infusion

  • Albumin PaclitaxelDrug

    administered via IV infusion

  • GolidocitinibDrug

    75mg, once a day orally

Study groups in NCT06969612
Study groupRoleWhat they receive
Golidocitinib combined with tislelizumab and chemotherapyExperimentalTake tislelizumab and chemotherapy for 2 cycles; and then take tislelizumab for 2 cycles and golidocitinib for 6 weeks; after cycle 5, patients receive tislelizumab and chemotherapy until the patients were intolerant or the disease progressed.
Receives: Drug: Tislelizumab; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel; Drug: Albumin Paclitaxel; Drug: Golidocitinib

What is being measured

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

  1. Progression Free Survival (PFS)

    PFS is defined as the time from the first dose until the first documentation of progression or death from any cause, whichever occurs first, as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Measured: Up to ~24 months

Secondary outcomes (6)

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with complete response (CR) or partial response (PR), as assessed by the investigator using RECIST v1.1.

    Measured: Up to ~24 months

  2. Disease Control Rate (DCR)

    DCR is defined as the percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD), as assessed by the investigator using RECIST v1.1.

    Measured: Up to ~24 months

  3. Duration of Response (DOR)

    DOR is defined as the time from the first occurrence of a objective response to the time of documented disease progression, or death from any cause, whichever comes first, as assessed by the investigator using RECIST v1.1

    Measured: Up to ~24 months

  4. Time To Response (TTR)

    TTR is defined as the time from the first dose to the first time of documented objective response, as assessed by the investigator using RECIST v1.1 in participants with documented objective responses

    Measured: Up to ~24 months

  5. Overall Survival (OS)

    OS is defined as the time from first dose until the date of death due to any cause

    Measured: Up to ~60 months

  6. Adverse events

    Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and immune-related adverse events (irAEs), which includes laboratory tests, physical exams, electrocardiogram results and vital signs, according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0

    Measured: Through study completion, an average of 2 year

Timeline

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

  1. First posted14 May 2025
  2. Study start15 May 2025
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06969612
Sponsor's protocol ID
2025YJZ14
Status last verified
Jun 2025
First submitted
26 Apr 2025
Last updated
6 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tislelizumab, Pemetrexed and Cisplatin in people with NSCLC (Advanced Non-small Cell Lung Cancer), run by Peking University Cancer Hospital & Institute 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 18 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: looking for participants now, as of the sponsor's last update on 6 Jun 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 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 Minglei Zhuo (+86 88196456, reyiza1993@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 (PFS) (time frame: Up to ~24 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 NCT06969612.

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 6 Jun 2025.

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