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

NCT06108726 | Unknown Phase 2

• 1 other identifier: xxingxiang
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

NSCLC

Outcome Measures

Primary Outcomes (3)

• Overall Survival(OS)

  OS is defined as the time from randomization to death due to any cause.

  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

  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).

  Up to 2 years

Secondary Outcomes (3)

• Disease control rate (DCR)

  Up to 2 years

• Duration of response (DOR)

  Up to 2 years

• Treatment related adverse events (TRAEs)

  from first dose to 30 days post the last dose

Study Arms (1)

envafolimab plus chemotherapy

EXPERIMENTAL

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

Drug: Envafolimab Injection

Interventions

Envafolimab Injection DRUG

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

Also known as: KN035

envafolimab plus chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. The subjects volunteered to participate in the study, signed the informed consent form, and had good compliance;
• \. ECOG≤2 ;
• Life expectancy of ≥12 weeks；
• Age ≥18 years;
• \. Diagnosed by histological examination and/or cytology examination, and imaging evaluation (refer to RECIST 1.1) for advanced central NSCLC;
• \. He had not received systemic chemotherapy previously.
• 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；
• Have adequate organ function。

You may not qualify if:

• This study was conducted five years prior to the initiation of treatment or concurrently with other malignant tumors.
• \. Have family history of cancer.
• had previously undergone any form treatment, such as surgery, chemotherapy, radiation therapy, etc.
• 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.
• Subjects with severe and/or uncontrollable disease progression；
• Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
• Pregnant or lactating women;
• Other conditions considered unsuitable for this study by the investigator.

Sponsors & Collaborators

• Northern Jiangsu People's Hospital: lead

Study Sites (1)

Northern Jiangsu People's Hospital

Suzhou, Jiangsu, 215163, China

RECRUITING

MeSH Terms

Interventions

envafolimab

Study Officials

• xu X xiang, Doctor

  Northern Jiangsu People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xu x xiang, Doctor

CONTACT

87373012; liuxy0229@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 31, 2023
• Study Start: October 18, 2023
• Primary Completion: January 18, 2025
• Study Completion: October 18, 2025
• Last Updated: October 31, 2023

Record last verified: 2023-10

Locations

CN (1)