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
NCT07643350 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 152
Last updated 2026-06-11
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.
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)。
Sponsors & Collaborators
-
The Third Xiangya Hospital of Central South University
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-15
- Primary Completion
- 2029-05-15
- Completion
- 2031-05-15
Countries
- China
Study Locations
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