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NOT YET RECRUITING
NCT07643350
PHASE2

Efficacy and Safety of Induction Benmelstobart Plus Anlotinib and Chemotherapy Followed by Concurrent Chemoradiotherapy and Benmelstobart Maintenance Versus Concurrent Chemoradiotherapy Followed by Benmelstobart Maintenance in Patients With Unresectable Stage III NSCLC

Sponsor: The Third Xiangya Hospital of Central South University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to compare the efficacy and safety of induction Benmelstobart plus Anlotinib and chemotherapy followed by concurrent chemoradiotherapy (CCRT) and subsequent Benmelstobart maintenance versus CCRT followed by Benmelstobart maintenance in patients with unresectable stage III NSCLC. Additionally, high-throughput sequencing and multi-omics analysis will be performed on patient-derived tissue and blood samples. By integrating baseline characteristics with clinical data, we aim to identify key determinants of treatment efficacy and prognosis, thereby establishing a precision evaluation system for therapeutic outcomes.

Official title: Comparison of the Efficacy and Safety of Induction Benmelstobart Plus Anlotinib and Chemotherapy Followed by Concurrent Chemoradiotherapy and Benmelstobart Maintenance Versus Concurrent Chemoradiotherapy Followed by Benmelstobart Maintenance in Patients With Unresectable Stage III NSCLC: A Randomized, Controlled, Multicenter Phase II Clinical Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

152

Start Date

2026-05-15

Completion Date

2031-05-15

Last Updated

2026-06-11

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

Benmelstobart

Group B:radical concurrent chemoradiotherapy → Maintenance therapy with Benmelstobart (for up to 1 year)

DRUG

benmelstobart combined with chemotherapy and anlotinib

Group A:Benmelstobart + Anlotinib + platinum-based dual-drug chemotherapy (2 cycles of induction therapy) → radical concurrent chemoradiotherapy (Benmelstobart and anlotinib discontinued during radiotherapy) → Benmelstobart maintenance therapy (for up to 1 year)。

Locations (1)

ThirdXiangyaHCSU

Changsha, Hunan, China