This is a single-arm, single-center, exploratory clinical study conducted at Shanghai Pulmonary Hospital, Tongji University. The study evaluates the effectiveness and safety of first-line treatment with benmelstobart (an immunotherapy), anlotinib (an anti-angiogenic drug), platinum-etoposide chemotherapy, and concurrent thoracic radiotherapy in participants with previously untreated, unresectable limited-stage small cell lung cancer (LS-SCLC). Eligible participants are aged 18 to 75 years, with histologically or cytologically confirmed limited-stage SCLC (VALG staging), no prior systemic treatment for lung cancer, measurable lesions by RECIST 1.1, ECOG performance status 0-1, and adequate organ function. Participants receive 4 cycles of induction therapy (21 days per cycle), including benmelstobart intravenously every 3 weeks, anlotinib orally for 2 weeks on / 1 week off, and chemotherapy with carboplatin or cisplatin plus etoposide. Thoracic radiotherapy (60-70 Gy in 30-35 fractions) is given concurrently with chemotherapy cycles 1-3. After induction, participants receive maintenance therapy with benmelstobart plus anlotinib for up to 2 years or until disease progression or unacceptable side effects. The primary objective is to assess the Objective Response Rate (ORR) as evaluated by investigators using RECIST 1.1. Secondary objectives include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety assessments of adverse events graded by CTCAE 5.0. A total of 27 participants will be enrolled. The study is expected to start in March 2026, complete enrollment by September 2027, and end in March 2029. All participants will be regularly followed for efficacy and safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Anti-PD-L1 monoclonal antibody, immunotherapy.1200 mg/dose, Q21D (1 cycle), IV infusion.
Small molecule multi-target anti-angiogenic agent.12 mg/day, oral (2 weeks on/1 week off, repeated Q3W), taken with water at fixed time.
Chemotherapy agent.Carboplatin: Day 1, AUC 5 mg/mL/min (max 750 mg), IV infusion; Cisplatin: Day 1, 75-80 mg/m², IV infusion.
Chemotherapy agent. Days 1-3, 100 mg/m², IV infusion.
External beam intensity-modulated radiotherapy (IMRT) targeting the primary thoracic tumor, ipsilateral hilum, and mediastinal lymph node stations (per LS-SCLC staging guidelines). Initiated with Cycle 1 of chemotherapy; IMRT, 60-70 Gy in 30-35 fractions (1.8-2.0 Gy/fraction, once daily); target volumes: primary tumor + lymph nodes delineated on post-chemotherapy CT, investigator-adjusted individually.
Investigator-Assessed Objective Response Rate
According to RECIST 1.1 criteria, investigator assesses target lesion changes via imaging; calculates the proportion of subjects achieving complete response (CR) or partial response (PR)
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
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
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
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.
Progression-Free Survival (PFS)
Time from first treatment to disease progression or death from any cause, whichever occurs first
Time frame: From date of first study drug administration until the date of first documented disease progression (per RECIST v1.1) or death from any cause, whichever occurs first; assessed up to 24 months (maximum follow-up period).
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
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
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
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
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
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
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
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