Adebrelimab Plus Apatinib for Maintenance Therapy of Extensive Stage Small Cell Lung Cancer

NCT06480864 | Recruiting

• 1 other identifier: SHR-1316-SCLC-LN-001
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  To evaluate the efficacy of anti-tumor by Resist1.1 (In months)

  baseline up to approximately 6 month

Secondary Outcomes (6)

• Objective response rate (ORR)

  baseline up to approximately 6 month

• Disease control rate (DCR)

  baseline up to approximately 6 month

• Duration of Response (DOR)

  baseline up to approximately 12 months

• Overall survival (OS)

  baseline up to approximately 12 month

• Second progression-free survival (PFS2)

  baseline up to approximately 12 months

Other Outcomes (1)

• Correlation of biomarkers and tumour response

  baseline up to approximately 12 months

Study Arms (1)

Adebrelimab+Chemotherapy→Adebrelimab+ Apatinib

EXPERIMENTAL

Participants will receive adebrelimab plus carboplatin /cisplatin and etoposide during the induction phase (4-6 cycles of three weeks.). Thereafter, participants will receive maintenance (after induction phase) adebrelimab plus apatinib until persistent PD, intolerable toxicity or withdrawal of consent.

Drug: Adebrelimab Injection; Drug: Apatinib Mesylate Tablets; Drug: Carboplatin; Drug: Cisplatin; Drug: Etoposide

Interventions

Adebrelimab Injection DRUG

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.

Adebrelimab+Chemotherapy→Adebrelimab+ Apatinib

Apatinib Mesylate Tablets DRUG

Apatinib mesylate tablets (250 mg) will be administered orally in a 3-week treatment cycle, once a day.

Adebrelimab+Chemotherapy→Adebrelimab+ Apatinib

Carboplatin DRUG

Carboplatin (AUC 4-5mg/mL/min) intravenous infusion will be administered during the induction phase on day 1 in a 3-week treatment cycle.

Adebrelimab+Chemotherapy→Adebrelimab+ Apatinib

Cisplatin DRUG

Cisplatin (75mg/m2) intravenous infusion will be administered during the induction phase on day 1 in a 3-week treatment cycle.

Adebrelimab+Chemotherapy→Adebrelimab+ Apatinib

Etoposide DRUG

Etoposide(100mg/m2) intravenous infusion will be administered during the induction phase from day 1 to 3 in a 3-week treatment cycle.

Adebrelimab+Chemotherapy→Adebrelimab+ Apatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 Association, VALG stage);
• ECOG physical condition score is 0-2;
• Subjects 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 metastases are allowed to have cranial radiotherapy during induction chemotherapy;
• 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):
• \- Coagulation function must meet: INR ≤ 1.5 and APTT ≤ 1.5 ULN;
• 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;

You may not qualify 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 antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, CD137 agonists, or other agents that target T cells;
• 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 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;
• 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;
• Urine routine suggesting urinary protein ≥ (++), or 24h urine protein amount ≥ 1g or severe hepatic or renal insufficiency;
• 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;
• 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;
• 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;
• 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 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;
• 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;

Sponsors & Collaborators

• Yunpeng Liu: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (2)

The First Hospital of China Medical University

Shenyang, Liaoning, 110002, China

RECRUITING

The First Hospital of China Medical University

Shenyang, 110000, China

NOT YET RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

apatinib; Carboplatin; Cisplatin; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Xiujuan Qu

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiujuan Qu

CONTACT

13604031355; cmu1h_zlnk_trial@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 28, 2024
• Study Start: August 9, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 6, 2025

Record last verified: 2024-12

Locations

CN (2)