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

NCT06775275 | Recruiting Phase 2

• 1 other identifier: NSCLC-II
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Resectable Lung Non-Small Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Pathological complete response

  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

  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.

Secondary Outcomes (4)

• 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.

• Overall response rate

  After 4 cycles of neoadjuvant therapy(3 weeks per cycle), before surgical resection was performed（at intervals of 4-6 weeks）.

• 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.

• 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.

Study Arms (2)

four-drug combination group

EXPERIMENTAL

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

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

three-drug combination group

EXPERIMENTAL

PD-L1 inhibitor with chemotherapy for neoadjuvant therapy

Drug: Adebellizumab; Drug: Platinum-based chemotherapy

Interventions

Adebellizumab DRUG

adebrelimab

four-drug combination group; three-drug combination group

Bevacizumab DRUG

bevacizumab

four-drug combination group

Platinum-based chemotherapy DRUG

paclitaxel or albuminotaxol or docetaxel combined with platinum, pemetrexed combined with platinum. Platinums include carboplatin, cisplatin and nedaplatin.

Also known as: paclitaxel, albuminotaxol, docetaxel, pemetrexed, carboplatin, cisplatin, nedaplatin

four-drug combination group; three-drug combination group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

Department of Thoracic Surgery, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

RECRUITING

MeSH Terms

Interventions

Bevacizumab; Platinum Compounds; Paclitaxel; Docetaxel; Pemetrexed; Carboplatin; Cisplatin; nedaplatin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Inorganic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Coordination Complexes; Chlorine Compounds; Nitrogen Compounds

Study Officials

• Jianxing He

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianxing He

CONTACT

+86-20-83062807; jianxing.he@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: January 15, 2025
• Study Start: September 24, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)