A Study of Local Envafolimab Injection Combined With Chemotherapy in Non-small Cell Lung Cancer

NSCLC Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06108726
• Other study ID #: xxingxiang
• Status: Recruiting
• Phase: Phase 2
• Start date: October 18, 2023
• Est. completion date: October 18, 2025

Study information

• Verified date: October 2023
• Source: Northern Jiangsu Province People's Hospital
• Contact: xu x xiang, Doctor
• Phone: 87373012
• Email: liuxy0229[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: October 18, 2025
• Est. primary completion date: January 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

Intervention

Drug:
• Envafolimab Injection
Local injection of Envafolimab 5mg/kg plus platinum-based chemotherapy under fiberoptic bronchoscopy, Q2W.

Locations

Country	Name	City	State
China	Northern Jiangsu People's Hospital	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Northern Jiangsu Province People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival(OS)	OS is defined as the time from randomization to death due to any cause.	Up to 2 years
Primary	Objective Response Rate(ORR)	ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1	Up to 2 years
Primary	Progression free survival(PFS)	Progression free survival (PFS) is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1).	Up to 2 years
Secondary	Disease control rate (DCR)	DCR is defined as the proportion of subjects with CR, PR, or SD based on RECIST v1.1.	Up to 2 years
Secondary	Duration of response (DOR)	DOR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST v1.1) or death due to any cause, whichever occurs first.	Up to 2 years
Secondary	Treatment related adverse events (TRAEs)	The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0	from first dose to 30 days post the last dose