A Study of Adebrelimab Combined With Apatinib Mesylate and Chemotherapy for Neoadjuvant Therapy and Biomarker Analysis in Limited-stage Small Cell Lung Cancer

NCT06483282 | Recruiting Phase 2

• 1 other identifier: IRB-2024-420
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, prospective, exploratory phase II clinical study. The study enrolled newly diagnosed stage T1-3N0-1M0 resectable limited-stage small cell lung cancer. Adebrelimab combined with chemotherapy for 4 cycles and apatinib mesylate for 3 cycles. Surgery was performed within 4-8 weeks after the above treatment (the operation was performed 4 weeks after apatinib was discontinued). According to the results of MDT discussion, adebrelimab combined with apatinib mesylate combined with or without radiotherapy was started 4 weeks after surgery. Preoperative prophylactic radiotherapy (PCI) is recommended for patients with preoperative stage N1. Patients with postoperative stage N1 received postoperative thoracic radiotherapy.

Conditions

Small Cell Lung Cancer Limited Stage

Outcome Measures

Primary Outcomes (1)

• EFS of 2 years

  The proportion of patients who did not experience any of the following events from the start of treatment to 2 years: disease progression without surgical treatment, local or distant recurrence, death from any cause, etc.

  Up to 2 years

Secondary Outcomes (6)

• MPR

  Up to 2 years

• EFS

  Up to 2 years

• OS

  Up to 2 years

• ORR

  Up to 2 years

• Treatment-Emergent Adverse Events [Safety and Tolerability]

  Up to 2 years

Study Arms (1)

Adebrelimab in combination with chemotherapy and apatinib mesylate

EXPERIMENTAL

Adebrelimab 1200mg q3w for 4 cycles, Apatinib mesylate 250mg qod q3w 3 times/week concurrent with adebrelimab for 3 cycles, platinum-based chemotherapy (etoposide, 100mg/m2, q3w; Carboplatin, AUC=5, q3w), 4 cycles, and operation was performed within 4-8 weeks after treatment (Apatinib mesylate was discontinued for 4 weeks). According to the results of MDT discussion, adebrelimab, 1200mg q3w, and apatinib 250mg qod q3w 3 times/week were used 4 weeks after surgery, which with or without radiotherapy. Preoperative prophylactic radiotherapy (PCI) is recommended for patients with preoperative stage N1. Patients with postoperative stage N1 received postoperative thoracic radiotherapy.

Drug: Adebrelimab; Drug: Apatinib Mesylate; Drug: Etoposide; Drug: Carboplatin

Interventions

Adebrelimab DRUG

This product is administered by intravenously guttae. The recommended dose of subcutaneous injection is 20mg/kg, administered every 3 Weeks (Q3W).

Also known as: SHR-1316

Adebrelimab in combination with chemotherapy and apatinib mesylate

Apatinib Mesylate DRUG

This product is an orally administered targeted therapy drug, with a recommended dosage of one tablet per day.

Adebrelimab in combination with chemotherapy and apatinib mesylate

Etoposide DRUG

This product is administered by intravenously guttae. The recommended dose of subcutaneous injection is 100mg/m2, administered every 3 Weeks (Q3W).

Adebrelimab in combination with chemotherapy and apatinib mesylate

Carboplatin DRUG

This product is administered by intravenously guttae. AUC=5, administered every 3 Weeks (Q3W).

Adebrelimab in combination with chemotherapy and apatinib mesylate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years old;
• Histologically or cytologically confirmed limited-stage small cell lung cancer (T1-3N0-1M0).
• All lesions of the patient (including the primary lesion, lymph nodes/lesions assessed as metastatic) must be jointly evaluated and confirmed as resectable by a surgeon, a radiation oncologist, and a radiologist;
• The subject must have measurable target lesions (according to RECIST 1.1 criteria);
• ECOG performance status score of 0-1;
• No history of other malignancies;
• No previous treatment for small cell lung cancer-related surgery, radiotherapy, chemotherapy, immunotherapy, or other anti-tumor treatments;
• The patient must have adequate cardiopulmonary function: the patient's FEV1 and DLCO are both ≥50% of the predicted value, echocardiography shows LVEF ≥55%, and no clear signs of heart failure, severe coronary artery stenosis, etc., are seen on various tests, and the cardiopulmonary function is assessed by a surgeon as being able to tolerate surgical treatment;
• The levels of important organ functions must meet the following requirements: a. Bone marrow: Absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelets ≥100×10\^9/L, hemoglobin ≥9 g/dl; b. Good coagulation function: defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5 times the upper limit of normal (ULN); c. Liver: Total bilirubin ≤1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal; d. Kidney: Serum creatinine ≤1.25 times the upper limit of normal or creatinine clearance (calculated using the Cockcroft-Gault formula) ≥60 ml/min;
• Males with reproductive capacity and women of childbearing age must agree to use effective contraception from the time of signing the main informed consent form until 180 days after the last administration of the study drug. Women of childbearing age include pre-menopausal women and post-menopausal women within 2 years. The pregnancy test result of women of childbearing age must be negative within ≤7 days before the first administration of the study drug;
• Voluntarily participate in clinical research; fully understand and be informed about this study and sign the informed consent form.

You may not qualify if:

• Inability to completely remove all lesions through surgery;
• Received anti-tumor treatment for SCLC (including but not limited to chemotherapy, radiotherapy of the lesion area).
• Previously used immunocheckpoint inhibitors such as PD-1/PD-L1 inhibitors for treatment.
• Have congenital or acquired immune system deficiencies, such as human immunodeficiency virus (HIV) infected individuals, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (positive for hepatitis C antibodies and HCV-RNA is above the lower limit of detection of the analytical method) or co-infection with both hepatitis B and C;
• Existence of uncontrollable third-space effusions, such as a large amount of pleural effusion or ascites or pericardial effusion;
• Subjects who need systemic treatment with corticosteroids (\>10 mg/day prednisone or equivalent) or other immunosuppressants within 14 days before the first administration of the drug. Inhaled or topical corticosteroids are allowed, as well as adrenal hormone replacement therapy with a dose \>10 mg/day prednisone equivalent, in the absence of active autoimmune diseases;
• Subjects who have been treated with anti-tumor vaccines or other immunostimulatory anti-tumor drugs (interferons, interleukins, thymosin, immune cell therapy, etc.) within 1 month before the first administration of the drug;
• Currently participating in other interventional clinical studies;
• Evidence of previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonia, and severe lung function impairment;
• Patients with severe heart disease, such as congestive heart failure grade III or above (NYHA standard), or angina grade III or above (CCS standard), or a history of myocardial infarction within 6 months before treatment initiation, or arrhythmias requiring drug treatment;
• Major surgery, open biopsy, or significant trauma within 28 days before enrollment;
• Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Pregnant or breastfeeding women; patients with fertility who are unwilling or unable to take effective contraceptive measures;
• Known allergic reactions, hypersensitivity, or intolerance to the study drug;
• Hypertension that cannot be well controlled with antihypertensive drug treatment (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);

Sponsors & Collaborators

• Jin Ying: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Interventions

apatinib; Etoposide; Carboplatin

Intervention Hierarchy (Ancestors)

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

Study Officials

• Da Chen, MD&PhD

  Medical Ethics Committee Of Zhejiang Cancer Hospital

  STUDY CHAIR

• Zhengfu He, MD&PhD

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

• Zhengliang Tu, MD&PhD

  Zhejiang University

  PRINCIPAL INVESTIGATOR

• Junqiang Fan, MD&PhD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Jin, MD&PhD

CONTACT

86+18806529092; jinying@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate chiefphysician, Department of Thoracic Medicine

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: July 3, 2024
• Study Start: June 21, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)