Combining Endostar with Chemotherapy and Immunotherapy for Lung Cancer

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

This study is testing if a new combination of chemotherapy, immunotherapy, and a drug called Endostar can help people with advanced lung cancer feel better and live longer.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 78 Years
• Sex: All
• Sponsor: Xuzhou Medical University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Yancheng, Jiangsu)
• Trial ID: NCT05782764 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of combining immune checkpoint inhibitors with chemotherapy and recombinant human endostatin in patients with advanced lung squamous cell carcinoma (stage IIIB-IV). It is a prospective, single-arm, single-center phase II study that targets patients who are inoperable and not suitable for radical concurrent chemoradiotherapy. Eligible participants will receive treatment until disease progression or other specified discontinuation criteria are met, with maintenance therapy following initial cycles of treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with advanced, inoperable squamous non-small cell lung cancer who have measurable lesions.

Not a fit: Patients with tumors that have invaded large blood vessels or those currently participating in other interventional clinical studies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new effective treatment option for patients with advanced lung squamous cell carcinoma.

How similar studies have performed: While this approach is innovative, similar studies combining immunotherapy with chemotherapy have shown promise in treating various cancers.

Eligibility criteria

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);

Where this trial is running

Yancheng, Jiangsu

• Yancheng Clinical College of Xuzhou Medical University — Yancheng, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: Xichao Dai — Yancheng Clinical College of Xuzhou Medical University
• Study coordinator: Min Liu

Conditions Lung Squamous Cell Carcinoma