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

ConditionNSCLC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Third Xiangya Hospital of Central South University

About this trial

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.

Eligibility criteria

Qualifiers

1. Voluntary signing of a written ICF.

2. Age at enrollment: 18-75 years; both sexes are eligible.

3. Eastern Cooperative Oncology Group (ECOG) performance status score: 0 or 1.

4. Expected survival: ≥3 months.

Disqualifiers

1. Histopathological presence of any small cell carcinoma components, as well as specific types such as salivary gland type and SMARCA4 deletion.

2. Except for NSCLC, the subject had suffered from other malignancies within the preceding 5 years. Subjects who have been cured of other tumors through local treatment (e.g., basal or squamous cell carcinoma of the skin, superficial bladder cancer, cervical or breast carcinoma in situ) are not excluded.

3. Concurrent enrollment in another clinical study, unless it is an observational, non-interventional clinical study or a follow-up phase of an intervention study.

4. Previous local treatments targeting the tumor lesion, such as thoracic radiotherapy or radiofrequency ablation.

Trial design

Treatments tested in this trial

  • Benmelstobart
  • benmelstobart combined with chemotherapy and anlotinib

Treatment groups

152 Participants
are divided into 2 treatment groups