A single-arm exploratory clinical study to observe and evaluate the first-line treatment of elderly and treatment-intolerant patients with small cell lung cancer using benmelstobart in combination with anlotinib and etoposide.
Eligible patients are those with histologically or pathologically confirmed small cell lung cancer (SCLC) (AJCC 9th edition), who are treatment-naïve and considered elderly or intolerant to intensive therapy. Eligible subjects receive 4-6 cycles of benmelstobart injection combined with anlotinib hydrochloride and etoposide, followed by maintenance therapy with benmelstobart injection plus anlotinib hydrochloride, continued until disease progression or intolerable toxicity.
The study aims to evaluate the efficacy and safety of first-line treatment with benmelstobart injection in combination with anlotinib hydrochloride and etoposide in patients with advanced SCLC.
The subject must voluntarily participate in this study after being fully informed and must sign a written informed consent form (ICF), and be willing and able to comply with the study procedures and requirements.
At the time of signing the ICF, male or female subjects aged ≥65 years, or male or female subjects aged ≥18 years who are assessed by the investigator as not suitable for intensive treatment, defined as: ECOG performance status of 2-3, or comorbidities (CIRS >6 and ≤12), or otherwise judged by the investigator as not suitable for intensive treatment. Intensive treatment is defined as first-line intensive therapy for metastatic small cell lung cancer, i.e., standard chemotherapy with etoposide plus cisplatin or carboplatin combined with immune checkpoint inhibitors and targeted agents.
Histologically or cytologically confirmed metastatic small cell lung cancer (SCLC), according to the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer TNM staging system, 9th edition (AJCC 9th).
Subjects must not have received prior systemic therapy for metastatic SCLC. Patients who previously received adjuvant, neoadjuvant, or radical chemoradiotherapy for non-metastatic disease are eligible if disease progression occurred >6 months after completion of the last treatment.
Prior anti-cancer therapy within specified time windows: Anti-PD-1/PD-L1 therapy within 3 years before first dose Anti-angiogenic multi-target TKIs (e.g., anlotinib, apatinib) within 3 years Any anti-cancer therapy (chemotherapy, targeted therapy, immunotherapy, etc.) or investigational drug within 28 days before first dose Traditional Chinese medicines with approved anti-cancer indications within 2 weeks before first dose (e.g., Fufang Banmao capsule, Kang'ai injection, Kanglaite capsule/injection, Aidi injection, Yadanzi oil injection/capsule, Xiaoaiping tablets/injection, Huachansu capsule, etc.)
Other primary malignancies, except: Tumors treated by single surgery with complete remission ≥3 years before enrollment Non-melanoma skin cancer or in situ cancers not requiring treatment Prostate cancer requiring only clinical observation
Symptomatic or progressing CNS metastases or carcinomatous meningitis. Patients with stable brain metastases may be eligible if: No neurological symptoms No corticosteroid use required and no indication for radiotherapy Largest brain lesion ≤1.5 cm Stable on two brain MRI/CT scans ≥2 weeks apart Additional timing and stability conditions after CNS treatment as specified Off corticosteroids ≥2 weeks if previously treated with CNS radiotherapy ≥4 weeks interval after CNS surgery before first dose
Cardiovascular conditions including: NYHA class II or higher heart failure Severe arrhythmia requiring treatment Myocardial infarction, unstable angina, or vascular bypass within 6 months LVEF <40% QTcF prolongation (female >470 ms, male >450 ms) or risk factors for torsades de pointes Uncontrolled hypertension (SBP ≥150 mmHg and/or DBP ≥100 mmHg despite treatment)