New treatment approach for central-type squamous lung cancer

Bronchial Artery Interventional Therapy and Sequential Radiotherapy in the Treatment of Non-resectable, Non-metastatic Central-type Squamous Lung Cancer

This study is testing a new treatment for patients with inoperable central-type squamous lung cancer to see if delivering immune therapy directly to the tumor can improve their outcomes.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Third Military Medical University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, prednisone
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT05892237 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates a novel treatment method for patients with inoperable central-type squamous cell lung cancer. The approach involves a surgical procedure called Chemo-Immuno-embolization via Tumor Arterial Intervention (CIETAI), which delivers PD-1/PD-L1 immune checkpoint inhibitors directly to the tumor through bronchial artery infusion. Following this intervention, patients will receive radiotherapy and maintenance therapy with PD-1/PD-L1 inhibitors. The goal is to enhance drug concentration in the tumor and improve treatment efficacy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with histologically confirmed T3-4 central-type squamous lung cancer who have not received prior systemic therapy.

Not a fit: Patients with resectable tumors or those who have received prior systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with advanced lung cancer who currently have limited options.

How similar studies have performed: While the use of PD-1/PD-L1 inhibitors has shown promise in other contexts, this specific approach of bronchial artery infusion is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Patients volunteered to participate in the study and signed the informed consent.
* Age 18-80, both male and female.
* Histologically or cytologically confirmed squamous lung cancer staging T3-4, Nany, and M0 (according to the American Joint Committee on Cancer Staging (AJCC) 2017 Edition 8 TNM Staging System). Central-type classified according to chest imaging or bronchoscopy.
* At least one measurable lesion according to RECIST 1.1.
* ECOG PS 0-1.
* Expected survival ≥ 6 months.
* Patients who never received systemic therapy in the past, including radiotherapy, chemotherapy, targeted therapy and immunotherapy, or patients who relapsed more than 6 months after adjuvant chemotherapy.
* The main organ functions accorded with the following criteria within 7 days before treatment:

  1. Blood routine examination ( without blood transfusion in 14 days): hemoglobin (HB) ≥ 90 g/L; neutrophil absolute value (ANC) ≥ 1.5 \*109/L; platelet (PLT) ≥80 \*109/L.
  2. Biochemical tests should meet the following criteria: 1) total bilirubin (TBIL) ≤1.5 times of upper limit of normal (ULN); 2) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 \*ULN, if accompanied by liver metastasis, ALT and AST ≤ 5\* ULN; 3) serum creatinine (Cr) ≤ 1.5\* ULN or creatinine clearance rate (CCr) ≥ 60 ml/min;4) Serum albumin (≥35g/L). (3) Doppler echocardiography: left ventricular ejection fraction (LVEF) ≥the low limit of normal value (50%).
* Tissue samples should be provided for biomarker analysis (such as PD-L1) Patients who could not provide new tissues could provide 5-8 paraffin sections of 3-5 μm by archival preservation. Blood sample should be collected at a pre-specified time point to complete the continuous dynamic MRD analysis. (non-mandatory).

Exclusion Criteria:

* Severe allergic reactions to humanized antibodies or fusion proteins in the past.
* Severe allergic reactions to component contained in contrast agent or granule embolism agent in the past.
* Metastasis to bone, brain, liver, pleural cavity, or any other distant organs.
* Diagnosed of immunodeficiency or received systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days before the study, allowing physiological doses of glucocorticoids (≤10mg/day prednisone or equivalent).
* Patients with active, known or suspected autoimmune diseases. Patients with type I diabetes, hypothyroidism requiring hormone replacement therapy, skin disorders requiring no systemic treatment (such as vitiligo, psoriasis or alopecia). Patients who would not triggers can be included.
* Serious heart disease, include congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction, and severe valvular disease.
* Patients received systemic antineoplastic therapy, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or mitomycin C within 6 weeks before the grouping),recieved over-extended-field radiotherapy (EF-RT) within 4 weeks before the grouping or limited-field radiotherapy to evaluate the tumor lesions within 2 weeks before the grouping.
* Positive hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus antibody (HCV Ab), indicating acute or chronic infection.
* Patients with active pulmonary tuberculosis (TB) infection judged by chest X-ray examination, sputum examination and clinical physical examination. Patients with active pulmonary tuberculosis infection in the previous year should be excluded even if they have been treated; Patients with active pulmonary tuberculosis infection more than a year ago should also be excluded unless the course and type of antituberculosis treatment previously were appropriate.
* Patients with brain metastases with symptoms or symptoms controlling less than 2 months.

Where this trial is running

Chongqing, Chongqing Municipality

• Daping Hospital, Third Military Medical University — Chongqing, Chongqing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Dong Wang, ph.D

Conditions Carcinoma, Non-Small-Cell Lung