Combining KN046 with Axitinib for treating resectable lung cancer
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
This study is testing if combining two drugs, KN046 and axitinib, can help improve surgery results for patients with early-stage lung cancer who haven't had treatment before.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Pulmonary Hospital, Shanghai, China Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, acitinib, axitinib |
| Locations | 2 sites (Nanchang, Jiangxi and 1 other locations) |
| Trial ID | NCT06020352 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of KN046 in combination with axitinib as a neoadjuvant therapy for patients with resectable non-small cell lung cancer (NSCLC). It focuses on assessing the major pathological remission rate and the surgical resection rate in patients scheduled for surgery. Participants must have stage IB-IIIB NSCLC and have not received prior anti-tumor treatments. The study aims to determine if this combination therapy can improve surgical outcomes for these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with resectable stage IB-IIIB NSCLC who have not undergone prior anti-tumor treatments.
Not a fit: Patients with central squamous NSCLC lesions at high risk of hemoptysis or those with interstitial lung disease requiring systemic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance surgical outcomes and improve survival rates for patients with resectable NSCLC.
How similar studies have performed: Other studies have shown promise in using combination therapies for NSCLC, but this specific combination of KN046 and axitinib is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Nanchang, Jiangxi and 1 other locations
- The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
- Shanghai Pulmonary Hospital — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Chang Chen, Dr
- Email: 2031222@tongji.edu.cn
- Phone: 65115006
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.