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

January 9, 2025 updated by: Jianxing He, The First Affiliated Hospital of Guangzhou Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Neoadjuvant therapy with experimental treatment followed by surgery.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Guangzhou, China
        • Recruiting
        • Department of Thoracic Surgery, The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
          • Wenhua Liang, MD
        • Contact:
        • Contact:
        • Contact:
          • Jianxing He, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: four-drug combination group
PD-L1 inhibitor with chemotherapy with Antiangiogenic therapy for neoadjuvant therapy
Drug: Bevacizumab
bevacizumab
Drug: Adebellizumab
adebrelimab
Drug: Platinum-based chemotherapy
paclitaxel or albuminotaxol or docetaxel combined with platinum, pemetrexed combined with platinum. Platinums include carboplatin, cisplatin and nedaplatin.
Other Names:
  • cisplatin
  • carboplatin
  • pemetrexed
  • docetaxel
  • paclitaxel
  • albuminotaxol
  • nedaplatin
Experimental: three-drug combination group
PD-L1 inhibitor with chemotherapy for neoadjuvant therapy
Drug: Adebellizumab
adebrelimab
Drug: Platinum-based chemotherapy
paclitaxel or albuminotaxol or docetaxel combined with platinum, pemetrexed combined with platinum. Platinums include carboplatin, cisplatin and nedaplatin.
Other Names:
  • cisplatin
  • carboplatin
  • pemetrexed
  • docetaxel
  • paclitaxel
  • albuminotaxol
  • nedaplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological complete response
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Pathological response
Time Frame: 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.
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
Time Frame: 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.
After 4 cycles of neoadjuvant therapy(3 weeks per cycle), before surgical resection was performed（at intervals of 4-6 weeks）.
event free survival
Time Frame: 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.
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
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Investigators

  • Principal Investigator: Jianxing He, The First Affiliated Hospital of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

November 18, 2024

First Submitted That Met QC Criteria

January 9, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSCLC-II

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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