About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female aged ≥18 years.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
Resectable non-small cell lung cancer harboring driver gene mutations.
At least one measurable disease based on Response Evaluation Criteria in Solid Tumors 1.1.
Disqualifiers
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).
Trial design
Single group
Treatments tested in this trial
Adebrelimab
DrugAdebrelimab IV
paclitaxel for injection (albumin bound)
Drugpaclitaxel for injection (albumin bound) IV
Cisplatin or Carboplatin
DrugCisplatin or Carboplatin IV
Treatment groups
Trial outcomes
Primary outcomes
Pathological complete response rate
pCR rate, the proportion of patients achieved pathologic complete response (lung and lymph node without tumor residual assessed by pathology review)
Secondary outcomes
Major pathologic response rate
MPR rate, the proportion of patients achieved pathologic complete response (lung and lymph node ≤10% tumor residual assessed by pathology review)
R0 rate
the proportion of patients achieved R0(No residue under the microscope after resection)
Event Free Survival
EFS, the time length from the first dose to any prescriptive events
Overall Survival
OS, the time length from the date of the first dose to the date of death.
Locations
Sponsors and contacts
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