Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT06739928

Irinotecan Liposome (II) or Etoposide Combined With Adebrelimab and Carboplatin in the Treatment of ES-SCLC

Led by Guangzhou Institute of Respiratory Disease · Updated on 2024-12-18

120

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is a prospective, randomized, parallel, multicenter phase II study aimed at evaluating the efficacy and safety of irinotecan liposome (II) or etoposide combined with adebrelimab and carboplatin as first-line treatment for extensive stage small cell lung cancer. The primary endpoint of the study was the 1-year overall survival rate.

CONDITIONS

Official Title

Irinotecan Liposome (II) or Etoposide Combined With Adebrelimab and Carboplatin in the Treatment of ES-SCLC

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathologically confirmed extensive-stage small cell lung cancer (ES-SCLC) according to the VALG system
  • No prior systemic treatment for cancer
  • At least 6 months since last radiation or chemotherapy before ES-SCLC diagnosis
  • At least one target lesion not previously irradiated
  • Male or female aged 18 to 70 years
  • ECOG performance status of 0 or 1
  • Life expectancy of at least 12 weeks
  • Adequate blood, liver, kidney, and coagulation function
  • Agreement to use contraception from the first dose until 6 months after last dose
  • Negative pregnancy test within 7 days before enrollment for women of childbearing potential
  • Voluntary informed consent given by the patient
Not Eligible

You will not qualify if you...

  • Mixed small cell and non-small cell lung cancer
  • Prior treatment with immune checkpoint inhibitors, irinotecan, or other DNA topoisomerase inhibitors
  • Use of strong CYP3A4 inducers or inhibitors close to starting study drug
  • Symptomatic brain metastasis, leptomeningeal metastasis, or spinal cord compression
  • Blood cancers including lymphoma, leukemia, multiple myeloma, aplastic anemia, myelodysplastic syndrome
  • Uncontrolled fluid buildup like pericardial or pleural effusion or ascites
  • Active or suspected autoimmune disease
  • Recent use of corticosteroids above 10 mg/day prednisone or immunosuppressants
  • Recent live vaccines or planned live vaccine during study
  • Lung diseases including interstitial, drug-induced, radiation-induced pneumonia needing steroids, or severe lung dysfunction
  • Active or recent tuberculosis within 48 weeks
  • Unresolved toxicities from prior cancer therapies
  • Recent minor surgery within 48 hours before study drug
  • Uncontrolled heart symptoms or diseases
  • Allergy to study drugs or their ingredients
  • Other cancers within 5 years except treated non-melanoma skin cancer or in situ carcinoma
  • History of psychiatric or substance abuse issues
  • Positive hepatitis B or C infection beyond allowed levels, or HIV/AIDS
  • Participation in other clinical trials or use of investigational drugs within 4 weeks
  • History of bone marrow or solid organ transplantation
  • Any other condition deemed unsuitable by the investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Guangzhou Institute of Respiratory Disease (Responsible Party)

Guangzhou, Guangzhou, China, 510120

Actively Recruiting

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Research Team

C

Chengzhi Zhou, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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