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New treatment option for Small Cell Lung Cancer
Official title Adebrelimab Plus Apatinib for Maintenance Therapy of Extensive Stage Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06480864
What this study is testing
What is Adebrelimab Injection?
Adebrelimab Injection is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for small cell lung cancer.
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
- To evaluate the efficacy and safety of maintenance therapy with Adebrelimab plus Apatinib for extensive stage small cell lung cancer after first-line induction of Adebrelimab plus chemotherapy.
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
- Participants voluntarily enrolled in this study and signed an informed consent form, were compliant and co-operated with follow-up visits;
- Age 18 years and above, male and female;
- Diagnosis of extensive stage small cell lung cancer (ES-SCLC) confirmed by histology or pathology (according to the American Veterans Lung Cancer...
- ECOG physical condition score is 0-2;
- people have not received systematic treatment for ES-SCLC in the past (including chemotherapy, VEGFR inhibitors and immune checkpoint inhibitors...
You likely can't join if
- Patients with meningeal metastases;
- Prior treatment with any T-cell co-stimulation or immune checkpoint therapy, including, but not limited to, cytotoxic T-lymphocyte-associated...
- Prior treatment with apatinib;
- Factors affecting oral administration of medications such as inability to swallow, post gastrointestinal resection, chronic diarrhoea, intestinal...
- Any active autoimmune disease or history of autoimmune disease (e.g., uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis...
- Patients with congenital or acquired immune function defects such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500...
See the full eligibility criteria
Who can join
- Participants voluntarily enrolled in this study and signed an informed consent form, were compliant and co-operated with follow-up visits;
- Age 18 years and above, male and female;
- Diagnosis of extensive stage small cell lung cancer (ES-SCLC) confirmed by histology or pathology (according to the American Veterans Lung Cancer Association, VALG stage);
- ECOG physical condition score is 0-2;
- people have not received systematic treatment for ES-SCLC in the past (including chemotherapy, VEGFR inhibitors and immune checkpoint inhibitors, etc.)
- Patients with limited stage small cell lung cancer (LS-SCLC) who have received radiotherapy, chemotherapy or radiochemotherapy require a treatment-free period of more than 6 months. Patients with asymptomatic brain...
- Life expectancy \>= 3 months;
- There must be a measurable target lesion that meets the RECIST 1.1 criteria (CT scan length of the tumour lesion \>10mm);
- The function of major organs is normal, that is, the following criteria are met.
- Blood routine (not transfused, not using haematopoietic factors and not corrected with drugs within 14 days): ANC ≥ 1.5 x 109/L; HB ≥ 90 g/L; PLT ≥ 100 × 109/L;
- Biochemical tests: TBIL ≤ 1.5ULN; TBIL ≤ 1.5 ULN; ALT, AST ≤ 2.5 ULN; \- Renal function: Serum creatinine (Cr) ≤ 1.5 x ULN or creatinine clearance ≥ 40 mL/min. (apply the standard Cockcroft-Gault formula): \-...
- Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the first dose. Female people of childbearing potential and male people whose partner is a female of...
- For males, surgical sterilisation or agreement to use a highly effective method of contraception for the duration of the trial and for 90 days after the final administration of study drug;
- For female participants, agreement to refrain from breastfeeding for the duration of the study or for 180 days after the last dose of study treatment is required.
What rules you out
- Patients with meningeal metastases;
- Prior treatment with any T-cell co-stimulation or immune checkpoint therapy, including, but not limited to, cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, CD137...
- Prior treatment with apatinib;
- Factors affecting oral administration of medications such as inability to swallow, post gastrointestinal resection, chronic diarrhoea, intestinal obstruction;
- Any active autoimmune disease or history of autoimmune disease (e.g., uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (may be included...
- Patients with congenital or acquired immune function defects such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive with HCV-RNA above...
- Urine routine suggesting urinary protein ≥ (++), or 24h urine protein amount ≥ 1g or severe hepatic or renal insufficiency;
- people requiring systemic therapy with corticosteroids (\>10 mg/day of prednisone or equivalent) or other immunosuppressive agents within 14 days prior to first dose. Inhaled or topical corticosteroids and adrenal...
- people who have been treated with antitumour vaccines or other antitumour agents with immunostimulatory effects (interferon, interleukin, thymidine, immune cell therapy, etc.) within 1 month prior to the first dose;
- Concomitant other malignancies ≤5 years prior to enrolment, except adequately treatable carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancer, localised prostate cancer after radical...
- Evidence of previous or current pulmonary fibrosis, interstitial pneumonitis, pneumoconiosis, radiographic pneumonia, drug-induced pneumonia, active pneumonia confirmed by imaging, and severely impaired lung function;
- Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg despite optimal pharmacological treatment);
- Myocardial ischaemia or myocardial infarction of class II or greater, poorly controlled arrhythmias (including QTc intervals ≥450 ms in men and ≥470 ms in women). Myocardial infarction, New York Heart Association class...
- Complicated severe infection within 4 weeks prior to first dose or unexplained fever \>38.5°C during screening/prior to first dose;
- Major surgery, open biopsy or significant trauma within 28 days prior to enrolment;
- An arterial/venous thrombotic event within 6 months;
- A significant risk of coughing up blood, bleeding events, or perforation as assessed by the investigator;
- Known history of allogeneic organ transplantation or allogeneic haematopoietic stem cell transplantation;
- Pregnant or lactating women; patients of childbearing potential who are unwilling or unable to use effective contraception;
- Known hypersensitivity, hypersensitivity or intolerance to adebelizumab, apatinib, chemotherapeutic agents or their excipients;
- Any condition which, in the opinion of the Investigator, may be detrimental to the subject or result in the subject's inability to meet or perform the requirements of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Shenyang, Liaoning, China
- Shenyang, 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 Shenyang, Liaoning, China; Shenyang, 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.