drugset / Trial / NCT06978153

This is a Two-cohort, Exploratory Clinical Study Assessing the Activity of Benmelstobart Combined With Chemotherapy With or Without Anlotinib in Resectable Limited-Stage Small Cell Lung Cancer

NCT06978153

Phase 2 Not yet recruiting 66 enrolled Tang-Du Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

A total of 66 patients were enrolled in this exploratory study and randomly assigned to cohort 1 and cohort 2, with 33 patients in each group. Cohort 1: Neoadjuvant therapy (benmelstobart combined with chemotherapy and anlotinib, 3 cycles, every 21 days is a cycle). Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Patients who achieved R0 resection received adjuvant therapy (benmelstobart combined with anlotinib, 12 cycles, every 21 days is a cycle). Cohort 2: Neoadjuvant therapy (benmelstobart combined with chemotherapy, 3 cycles, every 21 days is a cycle). Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Patients who achieved R0 resection received adjuvant therapy (benmelstobart, every 21 days is a cycle) .

Timeline

Start
2025-05-20
Primary completion
2027-11-01
Completion
2027-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Benmelstobart Monoclonal antibody 1200 mg Intravenous
Subject Catequentinib Small molecule 10 mg Oral
Background Carboplatin Small molecule
Background Cisplatin Other / unclassified 75 mg/m2
Background Etoposide Small molecule 100 mg/m2