A Study of Adebrelimab in Combination with Chemo with or Without Bevacizumab Neoadjuvant Therapy for Resectable NSCLC

Guangzhou Medical University

Status and phase: Enrolling; Phase 2

Conditions: Resectable Lung Non-Small Cell Carcinoma

Treatments: Drug: Bevacizumab; Drug: Adebellizumab; Drug: Platinum-based chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06775275

NSCLC-II

Details and patient eligibility

About

This is a prospective, multicenter, randomized, uncontrolled Phase II study to assess the efficacy and safety of adebrelimab in combination with chemotherapy with or without bevacizumab for the treatment of resectable Stage II-IIIB (T3N2) NSQ-NSCLC and to explore biomarkers associated with efficacy.

Full description

Neoadjuvant therapy with experimental treatment followed by surgery.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Resectable NSQ NSCLC
• Age 18-65 years
• male or female
• ECOG 0-1
• Subjects have not received surgery, chemotherapy, radiotherapy and biological treatment of treatment-naive non-squamous non-small cell lung cancer
• Subjects must have adequate pulmonary function for the intended pneumonectomy;

Exclusion criteria

• SCLC or SQ NSCLC
• previously used anti-PD1, anti-PDL1, anti-CTLA4 antibodies, etc.
• patients who have previously used anti-angiogenic drugs;
• allergic to any component of the study drug or chemotherapy drugs
• patients with any severe and or uncontrolled disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

four-drug combination group

Experimental group

Description:

PD-L1 inhibitor with chemotherapy with Antiangiogenic therapy for neoadjuvant therapy

Treatment:

Drug: Platinum-based chemotherapy

Drug: Adebellizumab

Drug: Bevacizumab

three-drug combination group

Experimental group

Description:

PD-L1 inhibitor with chemotherapy for neoadjuvant therapy

Treatment:

Drug: Platinum-based chemotherapy

Drug: Adebellizumab