NSCLCPhase 2NCT06108726
A Study of Local Envafolimab Injection Combined With Chemotherapy in Non-small Cell Lung Cancer
A Phase 2 study testing Envafolimab Injection in people with NSCLC, run by Northern Jiangsu People's Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Envafolimab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2023to 18 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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。
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Northern Jiangsu People's Hospital
Suzhou, Jiangsu, 215163
xu x xiang, Doctor, 87373012 ext. 514, liuxy0229@163.com
About this study
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
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.
Read the 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.
- Conditions
- NSCLC
- Being tested
- Envafolimab Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Envafolimab InjectionDrug
Also called KN035
Local injection of Envafolimab 5mg/kg plus platinum-based chemotherapy under fiberoptic bronchoscopy, Q2W.
| Study group | Role | What they receive |
|---|---|---|
| envafolimab plus chemotherapy | Experimental | Local injection of Envafolimab 5mg/kg plus platinum-based chemotherapy under fiberoptic bronchoscopy, Q2W. Receives: Drug: Envafolimab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival(OS)
OS is defined as the time from randomization to death due to any cause.
Measured: Up to 2 years
Objective Response Rate(ORR)
ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1
Measured: Up to 2 years
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).
Measured: Up to 2 years
Secondary outcomes (3)
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or SD based on RECIST v1.1.
Measured: Up to 2 years
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.
Measured: Up to 2 years
Treatment related adverse events (TRAEs)
The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0
Measured: from first dose to 30 days post the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start18 Oct 2023
- Primary completion18 Jan 2025 (estimated)
- Study completion18 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xu xingxiang, Northern Jiangsu People's Hospital
- Investigators
- xu X xiang, Doctor, Principal investigator, Northern Jiangsu People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108726
- Sponsor's protocol ID
- xxingxiang
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06108726
- Acronym / sponsor ID
- xxingxiang
- Conditions
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 18 Jan 2025 (estimated)
- Study completion
- 18 Oct 2025 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| envafolimab plus chemotherapy | Experimental | Drug: Envafolimab InjectionLocal injection of Envafolimab 5mg/kg plus platinum-based chemotherapy under fiberoptic bronchoscopy, Q2W. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (8 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Envafolimab InjectionAlso: KN035Local injection of Envafolimab 5mg/kg plus platinum-based chemotherapy under fiberoptic bronchoscopy, Q2W. | Drug | envafolimab plus chemotherapy |
Primary outcome
Overall Survival(OS)
Time frame: Up to 2 years
OS is defined as the time from randomization to death due to any cause.
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
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).
3 secondary outcomes
Disease control rate (DCR)
Time frame: Up to 2 years
Duration of response (DOR)
Time frame: Up to 2 years
Treatment related adverse events (TRAEs)
Time frame: from first dose to 30 days post the last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
xu X xiang, Doctor principal investigator
Northern Jiangsu People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Envafolimab Injection in people with NSCLC, run by Northern Jiangsu People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xu x xiang, Doctor (87373012 ext. 514, liuxy0229@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival(OS) (time frame: Up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.