A Prospective, Single-arm Study of Adebrelimab in Combination With Paclitaxel for Injection (Albumin Bound) and Platinum Chemotherapy as Neoadjuvant Therapy in Resectable Non-Small Cell Lung Cancer (NSCLC) Harboring Driver Gene Mutations

Liaoning Tumor Hospital & Institute0 sites36 target enrollmentApril 15, 2024

ConditionsNon Small Cell Lung Cancer

InterventionsAdebrelimab paclitaxel for injection (albumin bound)Cisplatin or Carboplatin

DrugsAdebrelimab paclitaxel for injection (albumin bound)Cisplatin or Carboplatin

Overview

Phase: Phase 2
Intervention: Adebrelimab
Conditions: Non Small Cell Lung Cancer
Sponsor: Liaoning Tumor Hospital & Institute
Enrollment: 36
Primary Endpoint: Pathological complete response rate
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a prospective, single-arm study to investigate the efficacy and safety of Adebrelimab in combination with paclitaxel for injection (albumin bound) and platinum chemotherapy as neoadjuvant therapy in resectable non-small cell lung cancer harboring driver gene mutations

Registry

clinicaltrials.gov

Start Date

April 15, 2024

End Date

April 15, 2029

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Liaoning Tumor Hospital & Institute

Responsible Party

Principal Investigator

Hongxu Liu

Chief Physician

Liaoning Tumor Hospital & Institute

Eligibility Criteria

Inclusion Criteria

•Male or female aged ≥18 years.
•Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-
•Resectable non-small cell lung cancer harboring driver gene mutations.
•At least one measurable disease based on Response Evaluation Criteria in Solid Tumors 1.
•Have adequate organ function.
•Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication；Females should not be breastfeeding；Female subjects of childbearing potential as well as males sexually active with women of childbearing potential must be willing to use an adequate method of contraception.
•Voluntarily comply with the treatment protocol.

Exclusion Criteria

•Previously treated with any anti-tumor therapy;
•Subject with known autoimmune disease
•Subject with known history of testing positive for human immunodeficiency virus (HIV) or known to have acquired immunodeficiency syndrome (AIDS), subject has known active hepatitis B or C.
•Presence of third space effusion that cannot be controlled by drainage or other means (e.g., excessive pleural fluid and ascites).
•Subject with severe liver and kidney dysfunction.
•Subjects who need to use corticosteroids (\>10 mg/day prednisone or equivalent dose of similar drugs) or other immunosuppressive therapy for systematic treatment within 14 days before the first administration of the study
•Subject with previous malignancies within 5 years, except for cured in situ cancer.
•Subject with previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-induced pneumonia and severe damage to lung function.
•Subject with uncontrolled hypertension.
•Prior organ transplantation including allogenic stem-cell transplantation.