- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06108726
A Study of Local Envafolimab Injection Combined With Chemotherapy in Non-small Cell Lung Cancer
October 29, 2023 updated by: xu xingxiang, Northern Jiangsu Province People's Hospital
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
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Estimated)
16
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: xu x xiang, Doctor
- Phone Number: 514 87373012
- Email: liuxy0229@163.com
Study Locations
-
-
Jiangsu
-
Suzhou, Jiangsu, China, 215163
- Recruiting
- Northern Jiangsu People's Hospital
-
Contact:
- xu x xiang, Doctor
- Phone Number: 514 87373012
- Email: liuxy0229@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: envafolimab plus chemotherapy
Local injection of Envafolimab 5mg/kg plus platinum-based chemotherapy under fiberoptic bronchoscopy, Q2W.
|
Local injection of Envafolimab 5mg/kg plus platinum-based chemotherapy under fiberoptic bronchoscopy, Q2W.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival(OS)
Time Frame: Up to 2 years
|
OS is defined as the time from randomization to death due to any cause.
|
Up to 2 years
|
Objective Response Rate(ORR)
Time Frame: Up to 2 years
|
ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1
|
Up to 2 years
|
Progression free survival(PFS)
Time Frame: Up to 2 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease control rate (DCR)
Time Frame: Up to 2 years
|
DCR is defined as the proportion of subjects with CR, PR, or SD based on RECIST v1.1.
|
Up to 2 years
|
Duration of response (DOR)
Time Frame: Up to 2 years
|
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
|
Treatment related adverse events (TRAEs)
Time Frame: from first dose to 30 days post the last dose
|
The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0
|
from first dose to 30 days post the last dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: xu X xiang, Doctor, Northern Jiangsu Province People's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 18, 2023
Primary Completion (Estimated)
January 18, 2025
Study Completion (Estimated)
October 18, 2025
Study Registration Dates
First Submitted
October 24, 2023
First Submitted That Met QC Criteria
October 29, 2023
First Posted (Actual)
October 31, 2023
Study Record Updates
Last Update Posted (Actual)
October 31, 2023
Last Update Submitted That Met QC Criteria
October 29, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- xxingxiang
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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