Benmelstobart, Anlotinib and Chemotherapy as First-line Treatment for Extensive-stage Small-cell Lung Cancer

NCT ID: NCT06931145

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2027-12-31

Brief Summary

The goal of this clinical trial is to evaluate the efficacy and safety of benmelstobart in combination with anlotinib and chemotherapy sequential benmelstobart in combination with anlotinib for the first-line treatment of extensive-stage small cell lung cancer.

Conditions

Extensive-stage Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Benmelstobart in combination with anlotinib and chemotherapy

Patients who met the enrollment criteria were first treated with benmelstobart in combination with anlotinib and carboplatin/cisplatin and etoposide for 4 cycles, and for non-progressing patients were evaluated by the investigator to receive maintenance therapy with benmelstobart in combination with anlotinib, which was continued until clinical benefit was lost or toxicity was intolerable or efficacy was evaluated to be PD, or continuation of the medication was deemed unsuitable by the investigator.

Group Type: EXPERIMENTAL

Benmelstobart

Intervention Type: DRUG

Benmelstobart injection, 1200 mg/dose, given once every 21 days, intravenously.

Anlotinib

Intervention Type: DRUG

Anlotinib hydrochloride capsules, 8 mg/dose, administered orally for 2 consecutive weeks and stopped for 1 week.

During the course of the study, subjects may be adjusted upward to a dose of 12 mg if well tolerated, as determined by the investigator, and the dose of anlotinib hydrochloride may be adjusted downward during the course of the study due to drug-related adverse events.

Carboplatin or cisplatin

Intervention Type: DRUG

Carboplatin for injection, administered on day 1, AUC 5 mg/mL/min, intravenously (maximal dose used is 750 mg); or cisplatin administered on day 1, 75-80mg/m2, IV.

Etoposide

Intervention Type: DRUG

Etoposide injection, 100mg/m2 on days 1, 2 and 3, IV.

Interventions

Benmelstobart

Benmelstobart injection, 1200 mg/dose, given once every 21 days, intravenously.

Intervention Type: DRUG

Anlotinib

Anlotinib hydrochloride capsules, 8 mg/dose, administered orally for 2 consecutive weeks and stopped for 1 week.

During the course of the study, subjects may be adjusted upward to a dose of 12 mg if well tolerated, as determined by the investigator, and the dose of anlotinib hydrochloride may be adjusted downward during the course of the study due to drug-related adverse events.

Intervention Type: DRUG

Carboplatin or cisplatin

Carboplatin for injection, administered on day 1, AUC 5 mg/mL/min, intravenously (maximal dose used is 750 mg); or cisplatin administered on day 1, 75-80mg/m2, IV.

Intervention Type: DRUG

Etoposide

Etoposide injection, 100mg/m2 on days 1, 2 and 3, IV.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1. Patients with pathologically confirmed extensive stage small cell lung cancer (VALG stage).
• 2. No prior systemic therapy for extensive-stage small cell lung cancer;
• 3. Patients who have received prior radiotherapy for limited-stage SCLC must have received radical therapy with a treatment-free interval of at least 6 months between the end of chemotherapy, radiotherapy, or radiochemotherapy and the diagnosis of extensive-stage SCLC (counting the time of completion of the last cycle of chemotherapy/time of completion of the last dose of radiotherapy);
• 4. The presence of a Measurable lesions as defined by the RECIST 1.1 criteria, where a previously irradiated lesion shows definite progression after radiotherapy and where this previously irradiated lesion is not the only lesion;
• 5. 18-75 years of age or older; ECOG score: 0-1; expected survival ≥ 3 months.
• 6. Adequate hematology and organ function, i.e., the following criteria are met:

a) Hematology (no transfusion of blood or blood products within 14 days, not corrected with G-CSF and other hematopoietic stimulating factors): i. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (1,500/mm3); ii. Platelet count (PLT) ≥ 100 × 109/L (100,000 /mm3); iii. Hemoglobin (HB) ≥ 80 g/L.

b) Renal: i. Creatinine clearance* (CrCl) calculated ≥ 50 mL/min; ii. Urine Protein < 2+ or 24 hour (h) urine protein quantification < 1.0 g.

c) Liver: i. Serum total bilirubin (TBil) ≤ 1.5 × ULN; ii. AST and ALT ≤ 2.5 × ULN; iii. serum albumin (ALB) ≥ 28 g/L.

d) Coagulation: i. International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN.

e) Cardiac Function: i. Left Ventricular Ejection Fraction (LVEF) ≥ 50%.

• 7, Subjects voluntarily enrolled in this study and signed an informed consent form, complied well and cooperated with the follow-up.

Exclusion Criteria

• 1, Patients with symptomatic brain metastases. Brain metastatic lesions that have been treated and kept in a clinically stable state of symptoms for at least 1 month, and do not use steroids and anticonvulsant drugs for at least 1 month prior to entering the study can be enrolled;
• 2. Previous use of anti-angiogenic drugs such as anlotinib, apatinib, bevacizumab, or related immunotherapeutic drugs targeting PD-1, PD-L1, etc.;
• 3. Those who have a wide range of factors affecting oral administration of the medication (e.g., the inability to swallow, After gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.);
• 4. Uncontrollable pleural effusion, pericardial effusion, or ascites that requires repeated drainage;
• 5. Patients with imaging evidence of tumor invasion of important perivascular vessels, or patients who, in the judgment of the investigator, are at high risk of fatal hemorrhage due to tumor invasion of an important blood vessel during the follow-up period of the study;
• 6. Patients with a history of severe hemorrhagic tendency or coagulation dysfunction including, but not limited to, clinical symptoms within 3 months prior to entry into the study. Clinically significant hemoptysis (greater than one tablespoon of hemoptysis per day) within 3 months prior to enrollment; or clinically significant bleeding symptoms or bleeding tendency within 4 weeks prior to enrollment, such as peptic hemorrhage, hemorrhagic gastric ulcers (including gastrointestinal perforation and/or fistulae, except that gastrointestinal perforation or fistulae that have been surgically resected may be permitted to be enrolled), non-healing wounds, ulcers, or bone fracture;
• 7. Patients who have received major Surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to enrollment;
• 8. Arterial/venous thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism, within 6 months prior to enrollment;
• 9. Active autoimmune disease requiring systemic therapy (e.g., palliative medications, corticosteroids, or immunosuppressants) within 2 years of the first dose;
• 10. Increased risk associated with participation in the study or study drug; and Other conditions that increase the risk associated with participation in the study or the study drug and, in the investigator's judgment, make the patient unsuitable for enrollment in the study;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wang mengzhao

chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Countries

China

Facility Contacts

Minjiang Chen

Role: primary

minjiangchen@163.com

+8601069155154

Other Identifiers

K7820

Identifier Type: -

Identifier Source: org_study_id