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

NCT ID: NCT06775275

Last Updated: 2025-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-24

Study Completion Date

2029-12-31

Brief Summary

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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

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Neoadjuvant therapy with experimental treatment followed by surgery.

Conditions

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Resectable Lung Non-Small Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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four-drug combination group

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

Group Type EXPERIMENTAL

Adebellizumab

Intervention Type DRUG

adebrelimab

Bevacizumab

Intervention Type DRUG

bevacizumab

Platinum-based chemotherapy

Intervention Type DRUG

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

three-drug combination group

PD-L1 inhibitor with chemotherapy for neoadjuvant therapy

Group Type EXPERIMENTAL

Adebellizumab

Intervention Type DRUG

adebrelimab

Platinum-based chemotherapy

Intervention Type DRUG

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

Interventions

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Adebellizumab

adebrelimab

Intervention Type DRUG

Bevacizumab

bevacizumab

Intervention Type DRUG

Platinum-based chemotherapy

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

Intervention Type DRUG

Other Intervention Names

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paclitaxel albuminotaxol docetaxel pemetrexed carboplatin cisplatin nedaplatin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Jianxing He

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jianxing He

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Guangzhou Medical University

Locations

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

Guangzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianxing He

Role: CONTACT

+86-20-83062807

Facility Contacts

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Jianxing He, MD

Role: primary

+86-20-83062807

Wenhua Liang, MD

Role: backup

+86-13710249454

Jianxing He, MD

Role: backup

Wenhua Liang, MD

Role: backup

Other Identifiers

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NSCLC-II

Identifier Type: -

Identifier Source: org_study_id

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