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Trial Title:
A Study of Local Envafolimab Injection Combined With Chemotherapy in Non-small Cell Lung Cancer
NCT ID:
NCT06108726
Condition:
NSCLC
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Envafolimab Injection
Description:
Local injection of Envafolimab 5mg/kg plus platinum-based chemotherapy under fiberoptic
bronchoscopy, Q2W.
Arm group label:
envafolimab plus chemotherapy
Other name:
KN035
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Northern Jiangsu People's Hospital
Address:
City:
Suzhou
Zip:
215163
Country:
China
Status:
Recruiting
Contact:
Last name:
xu x xiang, Doctor
Phone:
87373012
Phone ext:
514
Email:
liuxy0229@163.com
Start date:
October 18, 2023
Completion date:
October 18, 2025
Lead sponsor:
Agency:
Northern Jiangsu People's Hospital
Agency class:
Other
Source:
Northern Jiangsu People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06108726
