Local injection of envafolimab with chemotherapy for lung cancer

A Single-arm, Exploratory Clinical Trial Investigating the Efficacy of Local Envafolimab Injection Under Fiberoptic Bronchoscopy Combined With Chemotherapy in Non-small Cell Lung Cancer

This study is testing if local injections of a new drug called envafolimab, combined with chemotherapy, can help people with non-small cell lung cancer live longer and feel better.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Northern Jiangsu People's Hospital (other)
• Drugs / interventions: chemotherapy, radiation, envafolimab, immunotherapy
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT06108726 on ClinicalTrials.gov

What this trial studies

This exploratory clinical study aims to evaluate the safety and efficacy of local injections of envafolimab combined with chemotherapy in patients with non-small cell lung cancer (NSCLC). Sixteen patients will be enrolled to assess the treatment's effectiveness in prolonging progression-free survival (PFS) and overall survival (OS). The study will also observe changes in immune cells within the local immune microenvironment before and after treatment to identify new indicators for immunotherapy evaluation. The goal is to find a more effective treatment approach for NSCLC patients in China.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced central NSCLC who have not received prior systemic chemotherapy.

Not a fit: Patients with a history of other malignant tumors or those who have previously undergone any form of cancer treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with non-small cell lung cancer.

How similar studies have performed: While this approach is exploratory, similar studies combining immunotherapy with chemotherapy have shown promise in treating various cancers.

Eligibility criteria

Inclusion Criteria:

* 1. The subjects volunteered to participate in the study, signed the informed consent form, and had good compliance;
* 2. ECOG≤2 ;
* 3.Life expectancy of ≥12 weeks；
* 4.Age ≥18 years;
* 5. Diagnosed by histological examination and/or cytology examination, and imaging evaluation (refer to RECIST 1.1) for advanced central NSCLC;
* 6. He had not received systemic chemotherapy previously.
* 7.Had at least one measurable tumor lesion according to RECIST v1.1；That is, in CT or MRI detection, the longest diameter of a single lesion is ≥10mm, or the lymph node is pathologically enlarged, and the short diameter of a single lymph node on CT scan is ≥15mm；
* 8.Have adequate organ function。

Exclusion Criteria:

* 1.This study was conducted five years prior to the initiation of treatment or concurrently with other malignant tumors.
* 2. Have family history of cancer.
* 3.had previously undergone any form treatment, such as surgery, chemotherapy, radiation therapy, etc.
* 4.Only individuals experiencing grade 1 or higher unmitigated toxic effects (excluding alopecia and fatigue) resulting from previous therapies were eligible for enrollment; neurologic toxicity needed to return to grade 1 or lower or baseline before participation.
* 5.Subjects with severe and/or uncontrollable disease progression；
* 6.Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
* 7.Pregnant or lactating women;
* 8.Other conditions considered unsuitable for this study by the investigator.

Where this trial is running

Suzhou, Jiangsu

• Northern Jiangsu People's Hospital — Suzhou, Jiangsu, China (RECRUITING)

Study contacts

• Principal investigator: xu X xiang, Doctor — Northern Jiangsu People's Hospital
• Study coordinator: xu x xiang, Doctor

Conditions: NSCLC