This is a single-center, single-arm, exploratory clinical study conducted at Shanghai Pulmonary Hospital, Tongji University. It aims to evaluate the efficacy and safety of first-line treatment with benmelstobart plus anlotinib and chemotherapy (carboplatin/cisplatin plus etoposide), followed by sequential thoracic radiotherapy, in patients with previously untreated extensive-stage small cell lung cancer (ES-SCLC). Eligible participants will be adults aged 18-75 years with histologically or cytologically confirmed ES-SCLC, measurable lesions per RECIST 1.1, ECOG performance status 0-1, and adequate organ function. Patients will receive 4 cycles of induction therapy (benmelstobart, anlotinib, platinum-etoposide chemotherapy). Those without disease progression will receive consolidative thoracic radiotherapy, followed by maintenance therapy with benmelstobart plus anlotinib until disease progression or unacceptable toxicity. The primary endpoint is objective response rate (ORR) assessed by investigators. Secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety parameters including adverse events graded by CTCAE 5.0. A total of 33 subjects will be enrolled. This study uses a non-randomized, open-label design without a control group.
This is a single-center, single-arm, prospective, exploratory clinical trial to evaluate the efficacy and safety of first-line benmelstobart combined with anlotinib and platinum-etoposide chemotherapy, followed by sequential thoracic radiotherapy, in patients with untreated extensive-stage small cell lung cancer (ES-SCLC). Eligible patients will receive 4 cycles of 21-day induction therapy consisting of intravenous benmelstobart 1200 mg on day 1, oral anlotinib 12 mg once daily for 2 weeks on / 1 week off, plus carboplatin (AUC 5) or cisplatin (75-80 mg/m²) on day 1 and etoposide 100 mg/m² on days 1-3 of each cycle. Patients without disease progression after induction therapy will receive consolidative thoracic radiotherapy (2 Gy per fraction, 25-30 fractions). Maintenance therapy with benmelstobart plus anlotinib will be administered until disease progression, unacceptable toxicity, or a maximum of 2 years. The primary outcome is investigator-assessed objective response rate (ORR) per RECIST 1.1. Secondary outcomes include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety assessed by adverse events (AE, SAE, irAE) graded according to CTCAE version 5.0. A total of 33 subjects will be enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
A PD-L1 inhibitor (biological product) administered intravenously. Used for immunotherapy in combination with other agents to treat extensive-stage small cell lung cancer (ES-SCLC).
A small-molecule anti-angiogenic drug administered orally. Inhibits tumor angiogenesis to suppress tumor growth, used as part of the first-line combined therapy for ES-SCLC.
A platinum-based chemotherapeutic agent administered intravenously.
A topoisomerase II inhibitor administered intravenously. Works by interfering with tumor cell replication, combined with platinum agents as first-line chemotherapy for ES-SCLC.
External beam radiation therapy delivered to the thoracic region. Administered as consolidative treatment for non-progressive ES-SCLC patients after induction therapy, with a total dose based on clinical practice guidelines.
Objective Response Rate (ORR)
Investigator-assessed ORR per RECIST 1.1 in ES-SCLC patients treated with benmelstobart plus anlotinib and chemotherapy followed by thoracic radiotherapy.
Time frame: Baseline at screening, after every 2 treatment cycles (each cycle is 21 days), end of treatment, up to disease progression, assessed up to approximately 24 months
Progression-Free Survival (PFS)
Time from first treatment to disease progression or death from any cause, whichever occurs first
Time frame: Date of first study treatment to date of disease progression or death from any cause, last follow-up, assessed up to approximately 24 months
Overall Survival (OS)
Time from first study treatment to death from any cause; censored at last follow-up for alive subjects
Time frame: From date of first study treatment to date of death from any cause or last follow-up, whichever occurs first, assessed up to approximately 24 months
6-Month Progression-Free Survival Rate
Estimated proportion of subjects without progression and alive at 6 months after first treatment using Kaplan-Meier method
Time frame: 6-month time point after first treatment, follow-up cutoff
Serious Adverse Event (SAE)
Collect SAEs resulting in death, life-threatening condition, hospitalization, disability per CTCAE 5.0 and ICH-GCP, document and report
Time frame: from date of first study drug administration , follow-up until resolution or stabilization, assessed up to approximately 24 months
Adverse Event (AE)
Record all new or worsening unfavorable medical events, grade and calculate incidence according to CTCAE 5.0
Time frame: From signing informed consent through study completion and safety follow-up, assessed up to approximately 24 months
18-Month Overall Survival Rate
Estimated proportion of alive subjects at 18 months after first treatment via Kaplan-Meier method
Time frame: 18-month time point after first treatment, follow-up cutoff
Duration of Response (DOR)
Time from first confirmed CR/PR to disease progression, death from any cause, or initiation of new antitumor therapy
Time frame: From date of first confirmed objective response (CR/PR) until date of disease progression, death from any cause, or initiation of new antitumor therapy, whichever occurs first, assessed up to approximately 24 months
12-Month Progression-Free Survival Rate
Estimated proportion of progression-free and alive subjects at 12 months via Kaplan-Meier method
Time frame: 12-month time point after first treatment, follow-up cutoff
12-Month Overall Survival Rate
Estimated proportion of alive subjects at 12 months after first treatment using Kaplan-Meier method
Time frame: 12-month time point after first treatment, follow-up cutoff
Disease Control Rate (DCR)
According to RECIST 1.1, proportion of subjects achieving CR, PR, or stable disease (SD) in total enrolled population
Time frame: Time Frame: Baseline and after every 2 treatment cycles (each cycle is 21 days), up to disease progression, death, or study withdrawal, whichever occurs first,assessed up to approximately 24 months
Immune-Related Adverse Event (irAE)
Identify and grade organ-specific immune-related adverse events according to CTCAE 5.0 and irAE criteria
Time frame: From date of first study drug administration through 90 days after the last dose of study drug; assessed at baseline, each cycle visit, and unscheduled visits for suspected irAEs; graded per CTCAE 5.0 and irAE-specific criteria.
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