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New treatment option for SCLC
Official title Golidocitinib With PD-1 Inhibitors as Maintenance Treatment for Previously Untreated ES-SCLC
ClinicalTrials.gov ID: NCT07110103
What this study is testing
What is golidocitinib with PD-1 inhibitors?
golidocitinib with PD-1 inhibitors is an investigational medicine, being studied as a potential treatment for sclc.
Also referred to as AZD4205.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label, single-arm, phase 2 study to evaluate the safety and efficacy of golidocitinib with PD-1 inhibitors as maintenance treatment in patients with previously untreated extensive-stage small cell lung cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Able to provide a signed and dated informed consent form, including compliance with the requirements and restrictions listed in the ICF and this...
- people are ≥ 18 years old when signing the ICF;
- people have an ECOG performance status score of 0 or 1 and have not deteriorated in the past 2 weeks;
- Life expectancy ≥ 3 months;
- Histologically or cytologically confirmed ES-SCLC (stage IV [any T stage, any N stage, M1 a/b/c stage] according to the 8th edition of the AJCC TNM...
You likely can't join if
- Histopathological confirmation of the presence of mixed NSCLC and SCLC components;
- The presence of spinal cord compression or meningeal metastasis;
- Any of the following medical histories:
- Systemic treatment with Chinese patent medicines with anti-lung cancer indications or immunomodulatory drugs (including thymosin, interferon...
- Currently participating in treatment clinical research treatment, or receiving other research drugs or using research devices within 4 weeks before...
- Other major surgeries other than diagnosis or biopsy (excluding vascular access) within 4 weeks before the first dose, or major surgery is expected...
See the full eligibility criteria
Who can join
- Able to provide a signed and dated informed consent form, including compliance with the requirements and restrictions listed in the ICF and this protocol;
- people are ≥ 18 years old when signing the ICF;
- people have an ECOG performance status score of 0 or 1 and have not deteriorated in the past 2 weeks;
- Life expectancy ≥ 3 months;
- Histologically or cytologically confirmed ES-SCLC (stage IV [any T stage, any N stage, M1 a/b/c stage] according to the 8th edition of the AJCC TNM staging system for lung cancer, or T3-4 stage disease caused by...
- The presence of at least one measurable lesion (based on RECIST 1.1): with a long diameter ≥ 10 mm (lymph node lesions require a short diameter of ≥15 mm) that can be accurately and repeatedly measured at baseline under...
- SCLC patients who have not received any systemic anti-tumor treatment for advanced disease; if the patient has received neoadjuvant/adjuvant therapy in the past, the interval between the diagnosis of ES-SCLC and the...
- Patients must be suitable for platinum (cisplatin or carboplatin)-based chemotherapy as the first-line treatment for ES-SCLC;
- Adequate bone marrow reserve and organ system function reserve, summarized as follows:
- Absolute neutrophil count (ANC) ≥ 1.5×109/L without growth factor support;
- Platelet ≥ 100×109/L without growth factor support or blood transfusion;
- Hemoglobin ≥ 9 g/dL or 90 g/L without erythropoietin or blood transfusion;
- Total bilirubin ≤ 1.5 × ULN; if suffering from Gilbert syndrome (unconjugated hyperbilirubinemia), 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 by the Cockcroft-Gault method, \>60 ml/min for patients receiving cisplatin and \>45 ml/min for patients receiving carboplatin;
- Urine routine examination shows less than 2+ protein in urine, or 24-hour urine protein quantitative \<1 g;
- Good coagulation function, defined as international normalized ratio (INR) and/or prothrombin time (PT) ≤1.5 times ULN and/or activated partial thromboplastin time (APTT) ≤1.5 upper limit of normal; if the subject is...
- Serum amylase ≤1.5 times ULN and/or serum lipase ≤1.5 times ULN;
- Left ventricular ejection fraction (LVEF) ≥ 55%;
- For patients with central nervous system metastases, the following conditions must be met before they can be included:
- No neurological symptoms or symptoms are stable for at least 2 weeks after local treatment, no need to use corticosteroids or anti-epileptic drugs, and hormonal treatment has been stopped within 3 days before the first...
- If brain metastases have been treated locally (radiotherapy or surgery), there should be a time window of ≥ 2 weeks before the first dose of study treatment to ensure that local treatment-related adverse events have...
- Women of childbearing potential must undergo a urine and/or serum pregnancy test (if the urine test cannot be confirmed as negative) within 7 days before the first medication, and the result must be negative; WOCBP or...
- The people should be able to understand the study protocol and voluntarily comply with the study and follow-up;
- For patients who are about to enter the maintenance period, the investigator shall determine whether they are suitable for starting treatment with golidocitinib combined with PD-1 inhibitors (generally all previous...
What rules you out
- Histopathological confirmation of the presence of mixed NSCLC and SCLC components;
- The presence of spinal cord compression or meningeal metastasis;
- Any of the following medical histories:
- Systemic treatment with Chinese patent medicines with anti-lung cancer indications or immunomodulatory drugs (including thymosin, interferon, interleukin, excluding local use for the control of pleural effusion) within...
- Currently participating in treatment clinical research treatment, or receiving other research drugs or using research devices within 4 weeks before the first dose; any drug still in the development stage needs to be...
- Other major surgeries other than diagnosis or biopsy (excluding vascular access) within 4 weeks before the first dose, or major surgery is expected during the study;
- Palliative radiotherapy within 2 weeks before the first dose;
- Serious arterial/venous thrombotic events, including cerebrovascular accident (e.g., history of stroke or intracranial hemorrhage), deep vein thrombosis, and pulmonary embolism, occurred within 6 months before the first...
- Currently receiving (or unable to stop taking at least 1 week before the first dose) drugs, herbal supplements, and foods that are known to be strong inducers or inhibitors of CYP3A;
- Prior to the first dose, there was a CTCAE caused by previous treatment \> Grade 1 adverse events (except alopecia of any degree);
- Receiving solid organ or blood system transplantation (such as previous allogeneic bone marrow transplantation or whole blood transfusion within 120 days of sample collection during the study);
- Previous interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid hormone treatment, or current clinically active interstitial lung disease (including interstitial lung...
- Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, corticosteroids or immunosuppressants) within 2 years before the first dose. Replacement therapy (such as thyroxine...
- Diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of the study. Physiological doses of glucocorticoids (≤10...
- Diagnosed with other malignancies within 5 years before the first dose, excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has been evaluated to be clinically...
- Vaccinated with live vaccines within 30 days before the first dose (cycle 1, day 1), including live attenuated vaccines, excluding inactivated vaccines;
- Known active tuberculosis, such as positive tuberculin (PPD) test (nodule diameter \> 10 mm), positive T-SPOT test, chest X-ray/CT Tuberculosis lesions are found, or other positive results are found based on routine...
- people currently have severe infectious diseases that are difficult to control and must be excluded. After the recent infectious diseases are under control, the research team must determine whether they can be included...
- people with active infections, including but not limited to hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) and COVID-19 active infections (determined by the researchers to be...
- Meet any of the following cardiac criteria:
- Congestive heart failure (CHF) classified as class II by the New York Heart Association (NYHA);
- Clinically significant valvular heart disease, hypertrophic or constrictive cardiomyopathy;
- Any clinically significant abnormalities on resting ECG, such as complete left bundle branch block, 2/3 degree atrioventricular block, PR interval \> 250 msec;
- Average calibrated QTcF \> 470 msec of 3 resting ECGs during the screening period;
- people with any factors that may cause QT prolongation or increased risk of arrhythmic events (e.g., heart failure, hypokalemia, congenital long QT syndrome or a first-degree relative with long QT syndrome or a family...
- Ventricular arrhythmias requiring treatment;
- Acute myocardial infarction (AMI), unstable angina or new angina within 6 months before the administration of this study;
- Allergy to the drugs used in the study or their ingredients;
- Intractable nausea and vomiting, chronic gastrointestinal diseases, difficulty swallowing drugs, intestinal obstruction or previous intestinal resection, which may lead to inability to fully absorb the study drugs;
- Pregnant or lactating women;
- Known bleeding diathesis, that is, hemophilia, von Willebrand disease;
- The investigators assess that there are severe or uncontrollable systemic diseases (including poorly controlled hypertension and bleeding diseases) that cannot be carried out in clinical studies or may lead to poor...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Chongqing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Chongqing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.