A Study of Endostar Combined With Chemotherapy and Immunotherapy in Lung Squamous Cell Carcinom

A Single-arm, Exploratory Clinical Study of 3-day Continuous Intravenous Pump of Endostatin (Endostar) Combined With Chemotherapy and Immune Checkpoint Inhibitor in the Treatment of Advanced Lung Squamous Cell Carcinom

To explore the efficacy and safety of immune checkpoint inhibitor combined with endostar and chemotherapy in the treatment of advanced lung squamous cell carcinoma (stage IIIB-IV).

Study Overview

• Status: Recruiting
• Conditions: Lung Squamous Cell Carcinoma
• Intervention / Treatment: Drug: To explore the efficacy and safety of immune checkpoint inhibitor combined with endostar and chemotherapy in the treatment of advanced lung squamous cell carcinoma (stage IIIB-IV).

Detailed Description

This study is a prospective, single-arm, single-center phase II study to evaluate the efficacy and safety of immune checkpoint inhibitors in combination with chemotherapy and recombinant human endostatin in patients with advanced (stage IIIB-IV) squamous non-small cell lung cancer. Patients with locally advanced stage ⅢB/ⅢC, metastatic or recurrent stage IV squamous NSCLC who were not operable and could not receive radical concurrent chemoradiotherapy were selected after signing informed consent. Eligible subjects who met the inclusion criteria were screened for immune checkpoint inhibitor combined with chemotherapy and recombinant human endostatin. After cycles 4 to 6, maintenance therapy with an immune checkpoint inhibitor and endostatin was administered until disease progression, unacceptable toxicity, withdrawal of consent, initiation of additional antineoplastic therapy, death, or other protocol-specified discontinuation of treatment, whichever occurred first.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Min Liu; Phone Number: +86 66696891; Email: lmin89@163.com

Study Locations

• China
  • Jiangsu
    • Yancheng, Jiangsu, China, 224001
      • Recruiting
      • Yancheng Clinical College of Xuzhou Medical University
      • Contact: Xichao Dai; Phone Number: +8666696963; Email: rosefor1110@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1. Provided written informed consent before performing any trial-related procedures;

  2. Aged from 18 to 75 years old (including 75 years old);

  3. Patients with histologically or cytologically confirmed, locally advanced (stage IIIB/IIIC), metastatic, or recurrent (stage IV) squamous NSCLC according to the International Association for the Study of Lung Cancer and American Joint Committee on Classification of Cancer 8th Edition TNM classification of Lung cancer, who are inoperable and not amenable to definitive concurrent chemoradiotherapy;

  4. At least one radiographic measurable lesion according to response evaluation Criteria in Solid Tumors (RECIST, version 1.1);

Exclusion Criteria:

1. If the tumor had invaded large blood vessels on imaging (CT or MRI), or it was judged that the tumor was likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study;
2. Currently participating in an interventional clinical study treatment or receiving another study drug or study device within 4 weeks before the first dose;
3. Presence of active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction, and peritoneal metastasis requiring clinical intervention;
4. Grade III-IV congestive heart failure (New York Heart Association class) with poorly controlled clinically significant arrhythmias;
5. Any arterial thrombosis, embolism, or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack, occurred within 6 months before enrollment;
6. Known allergic reactions to the study drugs;
7. Patients requiring long-term systemic corticosteroids. Patients who required intermittent use of bronchodilators, inhaled corticosteroids, or topical corticosteroid injections due to COPD or asthma were eligible.
8. Symptomatic central nervous system metastases Patients with asymptomatic brain metastases or symptomatic stabilization of treated brain metastases were eligible to participate in the study if they met all the following criteria: measurable disease outside the central nervous system; No metastasis was found in midbrain, pons, cerebellum, meninges, medulla oblongata or spinal cord. Maintain a clinically stable state for at least 2 weeks; Hormone therapy was stopped 3 days before the first dose of study drug;
9. Active infection requiring treatment or use of systemic anti-infective agents within 1 week before the first dose;
10. Has not fully recovered from any intervention-related toxicity and/or complications before starting treatment (i.e., grade ≤1 or baseline, excluding fatigue or alopecia);
11. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive);
12. Untreated active hepatitis B (defined as both HBsAg positivity and HBV-DNA copies greater than the upper limit of normal in the laboratory of the participating center);

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: single arm; Recombinant human endostatin (CIV72h, D1-D3, 14 tubes) was administered by continuous intravenous infusion every 3 weeks. The drug was discontinued until disease progression or intolerable side effects.

Drug: To explore the efficacy and safety of immune checkpoint inhibitor combined with endostar and chemotherapy in the treatment of advanced lung squamous cell carcinoma (stage IIIB-IV).; immune checkpoint inhibitor combined with endostar and chemotherapy in the treatment of advanced lung squamous cell carcinoma (stage IIIB-IV).; Other Names: Endostar combined with immune checkpoint inhibitor and chemotherapy in the treatment of advanced lung squamous cell carcinoma (stage IIIB-IV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progression-free survival time	2months ~ 10 months
ORR	objective response rate	about 10months
AE	adverse reactions	about 10months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	overall survival	about 30 months

Collaborators and Investigators

• Sponsor: Xuzhou Medical University
• Investigators: Principal Investigator: Xichao Dai, Yancheng Clinical College of Xuzhou Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): May 30, 2025
• Study Completion (Anticipated): May 30, 2025

Study Registration Dates

• First Submitted: March 4, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Immune Checkpoint Inhibitors; Endostar protein
• Other Study ID Numbers: 2023-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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