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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-18

Study Completion Date

2025-10-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Envafolimab Combined With Endostar in the First-line Treatment of Advanced NSCLC

NCT05203276

Lung Neoplasms

UNKNOWN PHASE2

A Clinical Study of Immunotherapy Combined With Chemotherapy and Anti-angiogenic Therapy in Operable NSCLC

NCT05360979

Non-small Cell Lung Cancer

UNKNOWN PHASE2

First-line Replacement Maintenance of Envafolimab in Advanced NSCLC

NCT05465733

Non-Small-Cell Lung

UNKNOWN PHASE2

Envafolimab Combined With Chemotherapy and Recombinant Human Endostatin in the First-line Treatment of Sq-NSCLC

NCT05243355

Squamous Non-small Cell Lung Cancer

UNKNOWN PHASE2

Efficacy and Safety of First-line Treatment for Extensive-stage Small Cell Lung Cancer Using a Combination Therapy of Trilaciclib, Envafolimab, Etoposide, and Carboplatin

NCT06698965

Lung Cancer, Small Cell

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

NSCLC

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

envafolimab plus chemotherapy

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

Group Type EXPERIMENTAL

Envafolimab Injection

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Envafolimab Injection

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

KN035

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No