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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Benmelstobart

    Biological/Vaccine

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

  • benmelstobart combined with chemotherapy and anlotinib

    Drug

    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)。

Treatment groups

152 Participants
are divided into 2 treatment groups
Group A: Group A:Benmelstobart + Anlotinib+chemotherapyExperimental treatment 1 intervention
Group B: Group B：radical concurrent chemoradiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS)

Time frame
The duration from initiation of antitumor therapy until the documentation of disease progression (according to RECIST v1.1) or death from any cause (whichever occurs first).Up to 60 months from randomization

Secondary outcomes

1

Objective Response Rate (ORR)

Time frame
Primary efficacy assessment at Week 6 after randomization for the first 12 months, followed by every 3 months until disease progression, death or withdrawal of consent
2

Disease Control Rate (DCR)

Time frame
The proportion of subjects who achieved optimal overall response confirmed as CR, PR, or SD (according to the RECIST v1.1 )，Primary efficacy assessment at Week 6 after randomization for the first 12 months, followed by every 3 months
3

OS

Time frame
Time to death from any cause at the initiation of antitumor therapy, up to 60 months from randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Third Xiangya Hospital of Central South University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: