Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

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

A Study on the Efficacy and Safety of Golidocitinib Combined With Tislelizumab and Chemotherapy as First-line Treatment for Advanced NSCLC (NCT06969612) is a Phase 1 interventional studying NSCLC (Advanced Non-small Cell Lung Cancer), sponsored by Peking University Cancer Hospital & Institute. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For NSCLC (Advanced Non-small Cell Lung Cancer), a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 21 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Be able to provide the willing to sign a consent form form with signatures and signing dates, including compliance with the requirements and restrictions listed in the willing to sign a consent form Form (ICF) and this protocol; 2. At the time of signing the ICF, the age must be at least 18 years old, with no gender restrictions. 3. The ECOG score is 0 or 1. 4. Life expectancy ≥ 3 months; 5. 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; 6. PD-L1(22C3) ≥1%; 7. At least one measurable lesion (RECIST v1.1); 8. 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, blood count (hemoglobin) at least 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. 9. For patients with cancer that has spread to the brain, 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; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. 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; 2. At the time of signing the ICF, the age must be at least 18 years old, with no gender restrictions. 3. The ECOG score is 0 or 1. 4. Life expectancy ≥ 3 months; 5. 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; 6. PD-L1(22C3) ≥1%; 7. At least one measurable lesion (RECIST v1.1); 8. 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. 9. 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. 10. 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. Exclusion Criteria: 1. 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). 2. Have received systemic chemotherapy, biological therapy, targeted therapy or immunotherapy for metastatic or advanced NSCLC before; 3. Interstitial pneumonia/immune pneumonia or interstitial changes are known to exist; 4. Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active CNS metastases; 5. 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); * 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); 6. 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); 7. 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; 8. 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; 9. 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; 10. 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; 11. 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. 12. 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); 13. 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.

Treatments Being Tested

DRUG

Tislelizumab

200 mg, intravenously on Day 1, every 3 weeks

DRUG

Pemetrexed

administered via IV infusion

DRUG

Cisplatin

administered via IV infusion

DRUG

Carboplatin

administered via IV infusion

DRUG

Paclitaxel

administered via IV infusion

DRUG

Albumin Paclitaxel

administered via IV infusion

DRUG

Golidocitinib

75mg, once a day orally

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06969612), the sponsor (Peking University Cancer Hospital & Institute), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06969612 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06969612?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06969612?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06969612. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06969612. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.