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NCT Number: NCT06775275

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

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.

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Key information

Conditions

Resectable Lung Non-Small Cell Carcinoma

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

Neoadjuvant therapy with experimental treatment followed by surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adebellizumab

Drug

adebrelimab

Bevacizumab

Drug

bevacizumab

Platinum-based Chemotherapy

Drug

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

Other names: paclitaxel, albuminotaxol, docetaxel, pemetrexed, carboplatin, cisplatin, nedaplatin

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jianxing He

CONTACT

[email protected]

+86-20-83062807

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2029
First posted
Jan 15, 2025
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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