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

Phase 2

Recruiting

• Conditions: Resectable Lung Non-Small Cell Carcinoma
• Interventions: Drug: Adebellizumab; Drug: Bevacizumab; Drug: Platinum-based chemotherapy

• Registration Number: NCT06775275
• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Brief Summary

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.

Detailed Description

Neoadjuvant therapy with experimental treatment followed by surgery.

Study Timeline

• Study Start: 2024-09-24
• Study First Submitted: 2024-11-18
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-15
• Last Update Posted: 2025-01-15
• Primary Completion: 2025-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
four-drug combination group	Bevacizumab	PD-L1 inhibitor with chemotherapy with Antiangiogenic therapy for neoadjuvant therapy
four-drug combination group	Adebellizumab	PD-L1 inhibitor with chemotherapy with Antiangiogenic therapy for neoadjuvant therapy
four-drug combination group	Platinum-based chemotherapy	PD-L1 inhibitor with chemotherapy with Antiangiogenic therapy for neoadjuvant therapy
three-drug combination group	Adebellizumab	PD-L1 inhibitor with chemotherapy for neoadjuvant therapy
three-drug combination group	Platinum-based chemotherapy	PD-L1 inhibitor with chemotherapy for neoadjuvant therapy

Primary Outcome Measures

Name	Time	Method
Pathological complete response	After 4 cycles of neoadjuvant therapy(3 weeks per cycle), surgical resection was performed at intervals of 4-6 weeks. Pathological response assessment results were assessed within one week after surgery.	Pathological complete response, pCR (primary tumor + lymph nodes).It refers to the proportion of subjects with no residual surviving tumor cells (including lymph nodes) in the postoperative specimen among the enrolled subjects

Secondary Outcome Measures

Name	Time	Method
Major Pathological response	After 4 cycles of neoadjuvant therapy(3 weeks per cycle), surgical resection was performed at intervals of 4-6 weeks. Pathological response assessment results were assessed within one week after surgery.	It refers to the proportion of subjects with residual surviving tumor cells of ≤ 10% in the postoperative specimen among the enrolled subjects.
Overall response rate	After 4 cycles of neoadjuvant therapy(3 weeks per cycle), before surgical resection was performed（at intervals of 4-6 weeks）.	It refers to the proportion of patients whose tumor shrinks to a certain extent and maintains it for a certain period of time, including CR and PR cases.
event free survival	from randomization to imaging confirmation, local progression leading to inoperable tumors, unresectable tumors, local or distant recurrence, and death from any cause, whichever came first, assessed up to 24 months.	Defined as disease progression from randomization to imaging confirmation, local progression leading to inoperable tumors, unresectable tumors, local or distant recurrence, and death from any cause.
safety	Safety follow-up will be conducted 30 ± 7 days after the last use of bevacizumab/chemotherapy or 90 ± 7 days after the last use of adebrelimab/surgery (whichever occurs later) to track the relief of AE. Incidence of AE/SAE/TRAE will be recorded.	Monitoring and recording of adverse events, including Incidence of serious adverse events and adverse events of special interest.

Trial Locations

Locations (1)

Department of Thoracic Surgery, The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, China