Trial Title:
Adebrelimab Plus Apatinib for Maintenance Therapy of Extensive Small Cell Lung Cancer
NCT ID:
NCT06480864
Condition:
Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Carboplatin
Etoposide
Apatinib
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Adebrelimab Injection
Description:
Adebrelimab injection (1200mg) will be administered by intravenous infusion during the
induction phase and maintenance phase on day 1 in a 3-week treatment cycle.
Arm group label:
Adebrelimab+Chemotherapy→Adebrelimab+ Apatinib
Intervention type:
Drug
Intervention name:
Apatinib Mesylate Tablets
Description:
Apatinib mesylate tablets (250 mg) will be administered orally in a 3-week treatment
cycle, once a day.
Arm group label:
Adebrelimab+Chemotherapy→Adebrelimab+ Apatinib
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Carboplatin (AUC 4-5mg/mL/min) intravenous infusion will be administered during the
induction phase on day 1 in a 3-week treatment cycle.
Arm group label:
Adebrelimab+Chemotherapy→Adebrelimab+ Apatinib
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Cisplatin (75mg/m2) intravenous infusion will be administered during the induction phase
on day 1 in a 3-week treatment cycle.
Arm group label:
Adebrelimab+Chemotherapy→Adebrelimab+ Apatinib
Intervention type:
Drug
Intervention name:
Etoposide
Description:
Etoposide(100mg/m2) intravenous infusion will be administered during the induction phase
from day 1 to 3 in a 3-week treatment cycle.
Arm group label:
Adebrelimab+Chemotherapy→Adebrelimab+ Apatinib
Summary:
To evaluate the efficacy and safety of maintenance therapy with Adebrelimab plus Apatinib
for extensive small cell lung cancer after first-line induction of Adebrelimab plus
chemotherapy.
Detailed description:
This is a prospective, single-arm trial. To evaluate the efficacy and safety of
maintenance therapy with Adebrelimab plus Apatinib for extensive small cell lung cancer
after first-line induction of Adebrelimab plus chemotherapy.
Induction Period: Participants received adebrelimab (1200 mg, iv., Day1) + carboplatin
(AUC 4-5 mg/mL/min)/cisplatin (75 mg/m2) + etoposide (100 mg/m2, D1-3) for 4-6 cycles of
three weeks.
Maintenance phase: Participants received adebrelimab (1200mg, iv., Day1) + apatinib
(250mg, po., daily) once every three weeks.
Follow-up: If the participants have progression disease (PD) after maintenance therapy,
based on the investigator's judgement that the participants may still benefit from
continued treatment with adebrelimab in combination with apatinib, they may continue to
receive maintenance therapy with or without other therapy until the PD or intolerable.
The primary endpoint is progression-free survival (PFS). Secondary endpoints include
objective remission rate (ORR), disease control rate (DCR), duration of remission (DoR),
and overall survival (OS); PFS2 (defined as time from enrolment to second disease
progression or death) Our study will also explore biomarkers including: haematopoietic
factors (IL-6,IL-8, IL-10, etc.), PD-L1 expression, T-cell subsets, T-cell
immunoprecision typing and regulatory T-cell counts. The data from our study will provide
the basis for further prospective clinical trials (Phase III).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Participants voluntarily enrolled in this study and signed an informed consent form,
were compliant and co-operated with follow-up visits;
2. Age 18 years and above, male and female;
3. Diagnosis of extensive small cell lung cancer (ES-SCLC) confirmed by histology or
pathology (according to the American Veterans Lung Cancer Association, VALG stage);
4. ECOG physical condition score is 0-2;
5. Subjects have not received systematic treatment for ES-SCLC in the past (including
chemotherapy, VEGFR inhibitors and immune checkpoint inhibitors, etc.)
6. Limited stage SCLC in the past must have received radical treatment, and there is at
least 6 months' non-treatment interval from the end of chemotherapy, radiotherapy,
or radiotherapy and chemotherapy to the diagnosis of extensive stage SCLC;
7. Life expectancy >= 3 months;
8. There must be a measurable target lesion that meets the RECIST 1.1 criteria (CT scan
length of the tumour lesion >10mm);
9. 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):
- Coagulation function must meet: INR ≤ 1.5 and APTT ≤ 1.5 ULN;
10. Females of childbearing potential must have a negative serum or urine pregnancy test
within 72 hours prior to the first dose. Female subjects of childbearing potential
and male subjects whose partner is a female of childbearing potential must agree to
use a highly effective method of contraception and breastfeeding for the duration of
the study up to 90 days after the last administration of study drug. The
Investigator or his/her designee, in consultation with the subject, will be required
to confirm that the subject has knowledge of how to properly and consistently use
the contraceptive method;
11. 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;
12. 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.
Exclusion Criteria:
1. Patients with meningeal metastases;
2. 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 agonists, or other agents
that target T cells;
3. Prior treatment with apatinib;
4. Factors affecting oral administration of medications such as inability to swallow,
post gastrointestinal resection, chronic diarrhoea, intestinal obstruction;
5. 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 after hormone
replacement therapy), tuberculosis); and skin disorders (e.g., vitiligo, psoriasis,
or alopecia) in which asthma has been in complete remission in childhood and has
required no intervention in adulthood or in which systemic therapy is not required.
or alopecia areata) may be included; patients requiring medical intervention with
bronchodilators may not be included;
6. 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 the lower limit of
detection of the analytical method), or co-infection with both hepatitis B and
hepatitis C;
7. Urine routine suggesting urinary protein ≥ (++), or 24h urine protein amount ≥ 1g or
severe hepatic or renal insufficiency;
8. Subjects 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 hormone replacement therapy at doses
> 10 mg/day prednisone efficacy dose are permitted in the absence of active
autoimmune disease;
9. Subjects 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;
10. Within 4 weeks of the last systemic cytotoxic drug treatment or radiotherapy
treatment or currently using other anti-tumour drugs;
11. 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 surgery, and ductal carcinoma
in situ after radical surgery;
12. 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;
13. Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood
pressure ≥ 90 mmHg despite optimal pharmacological treatment);
14. 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 II or higher heart
failure, uncontrolled angina pectoris, uncontrolled severe ventricular arrhythmia,
clinically significant pericardial disease, or electrocardiogram suggestive of acute
ischaemia or active pericardial disease, within 6 months prior to enrolment,
according to NYHA criteria, class III-IV cardiac insufficiency or cardiac ultrasound
suggestive of a left ventricular ejection fraction (LVEF) of < 50% conduction system
abnormalities;
15. Complicated severe infection within 4 weeks prior to first dose or unexplained fever
>38.5°C during screening/prior to first dose;
16. Major surgery, open biopsy or significant trauma within 28 days prior to enrolment;
17. An arterial/venous thrombotic event within 6 months;
18. A significant risk of coughing up blood, bleeding events, or perforation as assessed
by the investigator;
19. Known history of allogeneic organ transplantation or allogeneic haematopoietic stem
cell transplantation;
20. Pregnant or lactating women; patients of childbearing potential who are unwilling or
unable to use effective contraception;
21. Known hypersensitivity, hypersensitivity or intolerance to adebelizumab, apatinib,
chemotherapeutic agents or their excipients;
22. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110000
Country:
China
Contact:
Last name:
Xiujuan Qu
Phone:
+86 13604031355
Start date:
July 2024
Completion date:
August 2026
Lead sponsor:
Agency:
Yunpeng Liu
Agency class:
Other
Collaborator:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
China Medical University, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06480864
