Clinical trial NCT06108726: A Study of Local Envafolimab Injection Combined With Chemotherapy in Non-small Cell Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: NSCLC
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this single-arm, exploratory clinical study is to evaluate the safety and efficacy of local injection of envafolimab combined with chemotherapy in the first-line treatment of non-small cell lung cancer (NSCLC) patients, and to observe the changes of immune cells in the local immune microenvironment before and after immunotherapy, in order to find new indicators for immunotherapy evaluation.

Detailed description: In this study, 16 patients with NSCLC were enrolled to explore the clinical effect of chemotherapy combined with local injection of Envafolimab. To determine whether the treatment of metastatic/recurrent NSCLC with Envafolimab is effective, and whether the treatment of Envafolimab combined with chemotherapy can prolong the PFS\\OS of patients with NSCLC, and to screen for a more effective treatment mode for Chinese NSCLC patients.

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.

Primary outcomes:
measure: Overall Survival(OS)
timeFrame: Up to 2 years
measure: Objective Response Rate(ORR)
timeFrame: Up to 2 years
measure: Progression free survival(PFS)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Disease control rate (DCR)
timeFrame: Up to 2 years
measure: Duration of response (DOR)
timeFrame: Up to 2 years
measure: Treatment related adverse events (TRAEs)
timeFrame: from first dose to 30 days post the last dose
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
Study officials:
affiliation: Northern Jiangsu People's Hospital
name: xu X xiang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: