RecruitingPhase 2NCT06775275

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

A Randomized Phase II Study of Adebrelimab in Combination with Chemotherapy with or Without Bevacizumab Neoadjuvant Therapy for Resectable Non-Squamous Non-Small Cell Lung Cancer


Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Enrollment

60 participants

Start Date

Sep 24, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria6

  • 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 Criteria5

  • 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

Interventions

DRUGAdebellizumab

adebrelimab

DRUGBevacizumab

bevacizumab

DRUGPlatinum-based chemotherapy

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


Locations(1)

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

Guangzhou, China

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NCT06775275


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