Recombinant Human Endostatin Combined With Envafolimab and Synchronal Radiochemotherapy

Recombinant Human Endostatin Combined With Evafolimab Injection and Synchronal Radiochemotherapy for First-line Treatment of Locally Advanced Stage III Squamous Non-small Cell Lung Cancer

This study is a prospective, single arm, single center open clinical study aimed at evaluating the efficacy and safety of recombinant human endostatin and envafolimab combined with synchronal radiochemotherapy in patients with locally advanced squamous non-small cell lung cancer who cannot undergo surgery in stage III.

Study Overview

• Status: Not yet recruiting
• Conditions: Locally Advanced Squamous Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Recombinant Human Endostatin Injection

Detailed Description

This study is a prospective, single arm, single center open clinical study aimed at evaluating the efficacy and safety of recombinant human endostatin and envafolimab combined with synchronal radiochemotherapy in patients with locally advanced squamous non-small cell lung cancer who cannot undergo surgery in stage III.

Patients with locally advanced stage III squamous non-small cell lung cancer who have not received systematic treatment in the past and cannot be treated surgically, after signing informed consent, qualified subjects who meet the inclusion criteria will be screened. They will receive 2 cycles of recombinant human endostatin combined with envafolimab and platinum containing chemotherapy. Radiotherapy will be carried out simultaneously in cycles 1-2, and after 2 cycles, they will receive maintenance treatment with envafolimab until the disease progresses and intolerable toxicity is detected, The treatment period does not exceed 12 months

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The patient voluntarily participated in this study, voluntarily underwent treatment and follow-up, and signed an informed consent form;
• According to the International Association for the Study of Lung Cancer and the Joint Committee on Cancer Classification, 8th edition of the TNM staging classification for lung cancer, locally advanced and unresectable stage III non-small cell lung cancer with histopathological diagnosis;
• According to the criteria for evaluating the efficacy of solid tumors (RECIST 1.1), there should be at least one imaging measurable lesion; Patients who have not received PD-1/PD-L1 antibody treatment in the past.
• 18-70 years old; ECOG PS score: 0-1 points; Expected survival period exceeding 3 months;
• Main organ functions meet treatment standards
• Women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study period and within 6 months after the end of the study; Within 7 days prior to enrollment in the study, the serum or urine pregnancy test was negative and must be a non lactating patient; Men should agree to patients who must use contraceptive measures during the study period and within 6 months after the end of the study period.

Exclusion Criteria:

• Patients who have previously received PD-1/PD-L1 antibody treatment;
• Respiratory syndrome caused by pleural effusion or ascites (according to NCICTCAE classification ≥ grade 2 dyspnea;
• Patients with brain metastases accompanied by symptoms or symptom control time less than 2 months;
• Has experienced or currently suffers from other malignant tumors within 5 years;
• Within the first 4 weeks of grouping or during the medication period of this study, it is planned to undergo systemic anti-tumor therapy, including cytotoxic therapy and targeted drug therapy. Received radiotherapy within 4 weeks prior to grouping;
• Patients with any severe and/or uncontrolled diseases
• Received significant surgical treatment, open biopsy, or obvious traumatic injury within 28 days prior to grouping;
• Patients with any signs of bleeding or medical history, regardless of severity; Within the first 4 weeks of grouping, patients with any bleeding or bleeding events ≥ CTCAE level 3, with unhealed wounds, ulcers, or fractures;
• Individuals who have experienced arterial/venous thrombosis events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis, and pulmonary embolism;
• Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders;
• Participated in clinical trials of other anti-tumor drugs within four weeks;
• According to the researcher's judgment, there are accompanying diseases that seriously endanger patient safety or affect patient completion of the study;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: recombinant human endostatin Group; Recombinant human endostatin and enrolizumab injection combined with Synchronal Radiochemotherapy	Drug: Recombinant Human Endostatin Injection; Recombinant Human Endostatin Injection：210 mg, intravenous infusion for 72 hours, once every three weeks cycle Evafolimab Injection：Subcutaneous injection on day 1, 8, and 15, once every three weeks cycle; Other Names: Evafolimab Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
objective response rate	After treatment, the ratio of patients assessed as CR and PR according to RECIST 1.1	After 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	The time from the start of treatment to death or last follow-up	The time from the start of treatment to death or last follow-up
Progression-free survival	The time from the start of treatment to the first recording of disease progression.	The time from the start of treatment to the first recording of disease progression

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Xinxiang Medical College

Study record dates

Study Major Dates

• Study Start (Estimated): February 18, 2024
• Primary Completion (Estimated): June 18, 2024
• Study Completion (Estimated): December 18, 2025

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: envafolimab; recombinant human endostatin; synchronal radiochemotherapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Endostatins
• Other Study ID Numbers: ZLXGBXKYXM-031-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Share mid-term data results and final data analysis results
• IPD Sharing Time Frame: Half a year to one year after the start of the research
• IPD Sharing Access Criteria: All can be accessed
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No