Combination treatment for advanced non-small cell lung cancer

The Efficacy and Safety of Drug Loaded Microsphere Bronchial Artery Chemoembolization (DEB-BACE) Combined With Anlotinib and Adebelimumab in the Third Line Treatment of Advanced NSCLC: a Prospective, Single Arm, Single Center, Exploratory Clinical Study

This study is testing a new combination treatment for people with advanced non-small cell lung cancer who haven't responded to previous therapies to see if it can help them.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ningbo Medical Center Lihuili Hospital (Government)
• Drugs / interventions: immunotherapy, adebelimumab, anlotinib
• Locations: 1 site (Ningbo, Zhejiang)
• Trial ID: NCT06188650 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of drug-loaded microsphere bronchial artery chemoembolization (DEB-BACE) combined with anlotinib and adebelimumab in patients with advanced non-small cell lung cancer (NSCLC) who have failed second-line treatment. Participants will receive DEB-BACE treatment followed by a cycle of anlotinib and adebelimumab, with a maximum of four DEB-BACE treatments based on therapeutic response. The study aims to provide insights into this combination therapy as a third-line treatment option.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with advanced NSCLC (stage III-IV) who have failed second-line treatment.

Not a fit: Patients who have previously received interventional therapy or PD-L1 inhibitor immunotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced NSCLC who have limited treatment choices.

How similar studies have performed: While this approach is exploratory, similar studies have shown promise in using combination therapies for advanced NSCLC.

Eligibility criteria

Inclusion Criteria:

1. Age\>18 years old, gender unlimited;
2. According to the Diagnosis and Treatment Guidelines for Primary Lung Cancer (2018 Edition), NSCLC was diagnosed by pathological histology;
3. TNM staging is III - IV;
4. Failure of second-line treatment according to the CSCO guidelines;
5. ECOG PS score ≤ 2 points;
6. Estimated survival time\>3 months;
7. Sign informed consent form

Exclusion Criteria:

1. Individuals who have previously received interventional therapy (iodine particle implantation, ablation, BACE treatment), or have received PD-L1 inhibitor immunotherapy during the first or second line standard treatment period of the patient;
2. Patients with other malignant tumors that have not been cured;
3. White blood cells\<3 × 109/L, absolute value of neutrophils\<1.5 × 109/L, neutrophil/lymphocyte ratio ≥ 3, platelet count\<50 × 109/L, hemoglobin concentration\<90 g/L;
4. Liver and kidney dysfunction (creatinine\>176.8) μ Mol/L; Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)\>twice the normal upper limit;
5. Central squamous cell carcinoma with cavity features;
6. Incorrectable coagulation dysfunction or concomitant active massive hemoptysis;
7. Patients with concurrent active infections who require antibiotic treatment;
8. Uncontrollable hypertension, diabetes, and cardiovascular diseases with obvious symptoms;
9. Contrast agent allergy;
10. Women with concurrent pregnancy or lactation

Where this trial is running

Ningbo, Zhejiang

• Kaitai Liu — Ningbo, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: kaitai liu, doctor

Conditions Non-Small Cell Lung Cancer