Study on the Therapeutic Effect of Irinotecan Liposomes in Small Cell Lung Cancer

NCT06467786 | Recruiting Phase 4

• 1 other identifier: 202402-30
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, multicenter, single arm Phase II exploratory study. It is expected to include 24 first-line patients with small cell lung cancer who have progressed after 6 months of treatment with platinum containing regimens, and receive treatment with irinotecan liposomes combined with cisplatin or carboplatin regimens.

Conditions

Small Cell Lung Cancer

Keywords

Small Cell Lung Cancer; Platinum sensitive; Irinotecan liposomes; Second-Line Therapy

Outcome Measures

Primary Outcomes (1)

• Intracranial Objective response rate

  Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments, is defined as the number (%) of patients with response of Complete Response or Partial Response, will be assessed up to 1 years.

  Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 years.

Secondary Outcomes (4)

• Progression-free survival

  Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 4 years

• Duration of Response

  Duration of Response（DoR）analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 4 years

• Overall Survival

  The maximum time from receiving treatment to dying for any reason is 4 years.

• Safety/Adverse event

  From the first recorded chemotherapy to 4 weeks after the last recorded chemotherapy

Study Arms (1)

Experimental administration group

EXPERIMENTAL

Irinotecan hydrochloride liposome injection: 70mg/m2, intravenous infusion CISPLATIN: 60mg/m2, intravenous infusion or carboplatin: AUC=5, intravenous infusion

Drug: Irinotecan hydrochloride liposome injection

Interventions

Irinotecan hydrochloride liposome injection DRUG

Irinotecan hydrochloride liposome injection combined with platinum

Experimental administration group

Eligibility Criteria

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

You may qualify if:

• The patient fully understands this study, voluntarily participates and signs an informed consent form (ICF).
• Age ≥ 18 years old;
• Patients with extensive stage small cell lung cancer diagnosed by pathology or histology;
• According to RECIST 1.1 standard, patients have at least one measurable target lesion; For lesions that have undergone radiation therapy in the past, they can only be included as measurable lesions if there is clear disease progression after radiation therapy;
• Progression confirmed by imaging examination after 6 months of first-line radiotherapy and chemotherapy containing platinum drugs or platinum regimen radiotherapy and chemotherapy ± immunotherapy;
• Eastern Cancer Collaborative Group (ECOG) physical fitness score: 0-2 points;
• Estimated survival time ≥ 3 months;
• Absolute neutrophil count (ANC) ≥ 1.5 x 10 \^ 9/L, platelet count ≥ 90 x 10 \^ 9/L, and hemoglobin count ≥ 90 g/L (no blood transfusion, blood products, use of granulocyte colony-stimulating factor or other hematopoietic stimulating factor correction within 14 days prior to laboratory examination);
• Liver and kidney function: serum creatinine ≤ 1.5 times the upper limit of normal value; AST and ALT ≤ 2.5 times the upper limit of normal values (≤ 5 times the upper limit of normal values for patients with liver invasion); Total bilirubin ≤ 1.5 times the upper limit of normal value (≤ 3 times the upper limit of normal value for patients with liver invasion);
• Women of childbearing age must undergo a pregnancy test (serum) within 7 days before enrollment, and the result is negative. They are willing to use appropriate methods of contraception during the trial period and 6 months after the last administration of the trial drug;

You may not qualify if:

• Patients with large cell neuroendocrine tumors and mixed small cell carcinoma;
• Patients with active brain metastasis or central nervous system invasion confirmed by imaging evaluation and/or biopsy (prednisone equivalent dose ≥ 10mg);
• There is an hypersensitivity reaction to any investigational drug or its components;
• Severe uncontrolled concurrent infections or other serious uncontrolled concomitant diseases, moderate or severe kidney injury; (such as progressive infection, uncontrollable hypertension, diabetes, etc.);
• Heart function and disease meet one of the following conditions:
• Long QTc syndrome or QTc interval\>480 ms;
• Complete left bundle branch block, II or III degree atrioventricular block;
• Severe and uncontrolled arrhythmias that require medication treatment;
• The New York College of Cardiology has a classification of ≥ III;
• Cardiac ejection fraction (LVEF) below 50%;
• A history of myocardial infarction, unstable angina, severe unstable ventricular arrhythmias, or any other arrhythmias requiring treatment, a history of clinically severe pericardial disease, or evidence of acute ischemic or active conduction system abnormalities on electrocardiogram within the 6 months prior to recruitment.
• Active infection of hepatitis B and hepatitis C (hepatitis B B virus surface antigen is positive and hepatitis B B virus DNA exceeds 1x103 copies/mL; hepatitis C virus RNA exceeds 1x103 copies/mL);
• Human Immunodeficiency Virus (HIV) infection (HIV antibody positive);
• Has previously or currently suffered from other malignant tumors (except for effectively controlled non melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ, and other malignant tumors that have not been treated and have been effectively controlled within the past five years);
• Pregnant and lactating women, as well as patients of childbearing age who are unwilling to take contraceptive measures;

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tangdu Hospital

Xi'an, Shannxi, 710038, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Haichuan Su, PhD

  Tang-Du Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haichuan Su, PhD

CONTACT

18629190366; such@fmmu.edu.cn

Jie Min, PhD

CONTACT

13709202616; minjie1504@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 21, 2024
• Study Start: March 15, 2024
• Primary Completion: September 15, 2025
• Study Completion (Estimated): September 15, 2028
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)