Adebrelimab Plus Chemotherapy as Neoadjuvant Therapy in Resectable NSCLC Harboring Driver Gene Mutations
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT06299371
- Lead Sponsor
- Liaoning Tumor Hospital & Institute
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 36
- 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.
- 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.
- 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.
- Known hypersensitivity to the study drug or any of its excipients.
- Other situations that the investigator considers unsuitable for the enrollment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description neoadjuvant immuno-chemotherapy paclitaxel for injection (albumin bound) Adebrelimab plus paclitaxel for injection (albumin bound) and platinum chemotherapy neoadjuvant immuno-chemotherapy Cisplatin or Carboplatin Adebrelimab plus paclitaxel for injection (albumin bound) and platinum chemotherapy neoadjuvant immuno-chemotherapy Adebrelimab Adebrelimab plus paclitaxel for injection (albumin bound) and platinum chemotherapy
- Primary Outcome Measures
Name Time Method Pathological complete response rate at 12 months pCR rate, the proportion of patients achieved pathologic complete response (lung and lymph node without tumor residual assessed by pathology review)
- Secondary Outcome Measures
Name Time Method R0 rate 12 months the proportion of patients achieved R0(No residue under the microscope after resection)
Major pathologic response rate 12 months MPR rate, the proportion of patients achieved pathologic complete response (lung and lymph node ≤10% tumor residual assessed by pathology review)
Event Free Survival up to 5 years EFS, the time length from the first dose to any prescriptive events
Overall Survival up to 5 years OS, the time length from the date of the first dose to the date of death.
Objective response rate 12 months ORR, the proportion of patients achieved complete or partial response
Adverse Events up to 5 years AEs