Etoposide Plus Benmelstobart Followed by Maintenance Therapy of Benmelstobart Plus Anlotinib in First-line Treatment of Elderly Patients with Extensive Stage Small Cell Lung Cancer: a Single-arm, Prospective Trial

NCT06825208 | Not Yet Recruiting

• 1 other identifier: 2450-E-A-ES-SCLC-001
• Study Type: observational
• Target: 29
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, single-arm clinical study to evaluate the efficacy and safety of etoposide in combination with bemosubezumab and sequential Benmelstobart in combination with Anlotinib as first-line treatment for elderly patients with extensive small-cell lung cancer. Participants who met the inclusion criteria were selected to enter the study and received etoposide combined with Benmelstobart followed by bemosubezumab combined with Anlotinib. The primary endpoint was PFS (Progression-free Survival), the secondary endpoint was OS (Overall Survival) and safety (CTCAE 5.0), and the exploratory endpoint was the screening of various potential molecular markers.

Conditions

Small Cell Lung Cancer Extensive Stage; ELDERLY PEOPLE

Outcome Measures

Primary Outcomes (1)

• Progression-free survival time

  It is the time that passes from a certain date (generally the first day of treatment, or the day in which a patient is enrolled in a clinical trial) and the date on which disease "progresses" or the date on which the patient dies, from any cause.

  From enrollment to the end of treatment at 18 months

Study Arms (1)

Elderly patients with extensive stage small cell lung cancer

Elderly patients with extensive small-cell lung cancer who have not previously received systematic treatment

Eligibility Criteria

• Age: 70 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from Nanjing First Hospital

You may qualify if:

• Patients with pathologically proven extensive small-cell Lung cancer (according to the Veterans Administration Lung Study Group, VALG stage) who have not previously received systematic treatment for extensive small-cell lung cancer;
• Patients who have previously received chemoradiotherapy for limited-stage SCLC must have received radical therapy and have at least 6 months of treatment-free intervals between the end of chemotherapy, radiotherapy, or chemoradiotherapy and the diagnosis of extensive SCLC (end time of last chemotherapy cycle/end time of last radiotherapy).
• There was no gender limitation. The subjects voluntarily joined the study, signed the informed consent, and the compliance was good
• Aged eligibility criteria are considered to be met if the following criteria are met:
• Patient requirements: Between 70 and 85 years old, and after independent assessment by two chief physicians, the patient's physical condition may not be able to tolerate platinum-containing chemotherapy regimen, and the patient's informed consent to accept the platinum treatment regimen;
• ECOG score: 0-2;
• At least one lesion can be measured by CT.
• Expect to survive for at least 3 months.
• The main organ functions within 7 days before treatment should meet the following criteria:
• \) Blood routine examination (under the condition of no blood transfusion or use of hematopoietic stimulating factor drugs for correction within 14 days): Hemoglobin (Hb) ≥ 90g/L; Absolute neutrophil count (ANC) ≥ 1.5×109/L; ； 1) Platelet count (PLT) ≥ 100×10⁹/L; white blood cell count (WBC) ≥ 3.0×10⁹/L.
• \) Biochemical tests: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (for patients with liver metastasis from tumors, ≤ 5×ULN); total bilirubin (TBIL) ≤ 1.5×ULN (for Gilbert's syndrome patients, ≤ 3×ULN); serum creatinine (Cr) ≤ 1.5×ULN or creatinine clearance rate ≥ 50 ml/min; 3) Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5×ULN; 4) Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥ 50%. 。
• Men should agree that contraception must be used during the study period and for 6 months after the end of the study period;

You may not qualify if:

• Used antiangiogenic drugs or related immunotherapy drugs such as PD-1 and PD-L1 in the past;
• Subjects with known central nervous system metastatic and/or cancerous meningitis; (Unless asymptomatic, or treated and stable, no radiographic evidence of new BMS or enlarged BMS was found at least 2 weeks after BMS treatment, and steroid or anticonvulsant therapy was discontinued for at least 14 days before study therapy began. If active or new untreated, asymptomatic CNS metastases are found on imaging in subjects during the screening period, radiation therapy or untreated imaging evidence of new or enlarged BMS is required for at least 2 weeks.)
• Subject has had or co-developed other malignancies (except cured basal cell carcinoma of the skin and cervical carcinoma in situ) within 5 years;
• Subject has multiple factors that affect oral medication (such as inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction);
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
• Spinal cord compression that has not been cured or alleviated by surgery and/or radiotherapy, or previously diagnosed spinal cord compression with no clinical evidence of disease stabilization ≥1 week prior to randomization after treatment;
• Imaging (CT or MRI) shows that the tumor invades the large blood vessels or has an unclear boundary with the large blood vessels;
• Subjects with evidence or history of bleeding tendencies, regardless of severity, within 2 months prior to initial dosing; A history of hemoptysis (defined as bright red or 1/2 teaspoon of blood) or unhealed wounds, ulcers, or fractures within 2 weeks prior to initial medication;
• Subjects whose adverse events (other than alopecia) from prior treatment did not recover to ≤CTCAE Class 1;
• Received major surgical treatment or significant traumatic injury within 28 days prior to randomization;
• Those who had experienced an arterial/venous thrombosis event, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism, within 6 months before randomization;
• have a history of psychotropic drug abuse and can not quit or have mental disorders;
• Subjects with any severe and/or uncontrolled medical condition, including:
• a) Subjects with unsatisfactory blood pressure control (systolic ≥150 mmHg or diastolic ≥100mmHg); b) have grade 2 myocardial ischemia or myocardial infarction, arrhythmias (including QTc≥450ms in men, QTc≥ 470ms in women), and grade 2 congestive heart failure (NYHA); c) Active or uncontrolled severe infection (≥CTC AE grade 2 infection); d) Cirrhosis, active hepatitis \*;
• \* Active hepatitis (Hepatitis B reference :HBsAg positive, and HBV DNA test value exceeds the upper limit of normal; Hepatitis C reference :HCV antibody positive, and HCV virus titer test value exceeds the upper limit of normal value); e) HIV positive test; f) Poor diabetes control (fasting blood glucose (FBG)\>10mmol/L); g) Urine routine indicated urine protein ≥++, and confirmed 24-hour urine protein quantity \>1.0 g;

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Central Study Contacts

Surong Fang

CONTACT

+86 15651981839; fangsurongjiang@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Respiratory and Critical Care Medicine

Study Record Dates

• First Submitted: February 9, 2025
• First Posted: February 13, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share