Clinical trial NCT06775275: A Study of Adebrelimab in Combination with Chemo with or Without Bevacizumab Neoadjuvant Therapy for Resectable NSCLC
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Resectable Lung Non-Small Cell Carcinoma
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Neoadjuvant therapy with experimental treatment followed by surgery.

Eligibility criteria: 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

Primary outcomes:
measure: Pathological complete response
timeFrame: 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:
measure: Major Pathological response
timeFrame: 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.
measure: Overall response rate
timeFrame: After 4 cycles of neoadjuvant therapy(3 weeks per cycle), before surgical resection was performed（at intervals of 4-6 weeks）.
measure: event free survival
timeFrame: 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.
measure: safety
timeFrame: 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.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Thoracic Surgery, The First Affiliated Hospital of Guangzhou Medical University
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Jianxing He
role: PRINCIPAL_INVESTIGATOR
References: