Study on the Efficacy and Safety of KN046 Combined With Acitinib as a Neoadjuvant Therapy in Resectable Stage IB-IIIB Non-small Cell Lung Cancer (NSCLC) Patients

STAR003

Evaluation of the efficacy of KN046 combined with acitinib as a neoadjuvant therapy for resectable NSCLC through primary pathological response rate and surgical resection rate

2023-08-25

2025-07-01

2025-07-01

Recruiting

Early phase I

20

Inclusion Criteria: 1. The subject is at least 18 years old and\<75 years old on the day of signing the informed consent form, regardless of gender, and is willing to follow the research procedure; 2. Confirmed by histology or cytology as non-small cell lung cancer; 3. NSCLC patients evaluated by researchers as resectable in stage IB-IIIB (stage IIIB only limited to T3N2M0) (AJCC 8th edition); 4. Has not received any anti-tumor treatment in the past, including but not limited to systemic chemotherapy, immunotherapy, or radiotherapy; 5. No allergenic EGFR mutation or ALK change; 6. The ECOG score is 0-1 points. Exclusion Criteria: 1. The lesion of squamous non-small cell lung cancer presents as a central type of lung cancer accompanied by cavity formation or invasion of blood vessels, with a high risk of hemoptysis; 2. Previously or currently suffering from interstitial pneumonia/lung disease that requires systemic hormone therapy; 3. Previous history of allogeneic bone marrow or organ transplantation; 4. Subjects who have undergone major surgical treatment (such as abdominal or thoracic surgery; excluding diagnostic puncture or peripheral vascular pathway replacement surgery) or have not recovered from surgical treatment within 28 days before the administration of this trial; 5. Prior to allocation, they have received systemic anti-cancer treatment, including research drugs targeting current malignant tumors; 6. Other known malignant tumors are progressing or require active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding bladder carcinoma in situ) who have received possible radical treatment are not excluded; 7. Pregnant and/or lactating women.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

2023-08-31