Study on Serplulimab and Chemotherapy for Extensive Stage Small Cell Lung Cancer in US Patients

Sponsor: Shanghai Henlius Biotech

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05468489

Provider View

This clinical trial is comparing two treatment options for US patients with extensive stage small cell lung cancer (ES-SCLC) who have not received prior treatment. The study will evaluate the effectiveness and safety of Serplulimab combined with chemotherapy against Atezolizumab combined with chemotherapy.

Patient Parameters

Program Overview

This study is testing two different treatment combinations for patients with extensive stage small cell lung cancer (ES-SCLC) who have not been treated before. Participants will be randomly assigned to one of two groups: one group will receive Serplulimab with chemotherapy drugs carboplatin and etoposide, and the other group will receive Atezolizumab with the same chemotherapy drugs. The goal is to see which combination works better and is safer for patients.

Eligibility Criteria

Inclusion Criteria

  • Willing to participate in the study.
  • Men and women aged 18 years or older.
  • Diagnosed with extensive stage small cell lung cancer (ES-SCLC).
  • No previous treatment for ES-SCLC.
  • Have at least one tumor that can be measured by scans.
  • Major organs are working well.
  • Provide tumor tissue samples for testing if possible.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Expected to live at least 12 more weeks.
  • If previously using denosumab for bone metastases, must switch to bisphosphonate therapy before starting the study.
  • Must use effective birth control during the study.

Exclusion Criteria

  • Diagnosed with a mixed type of small cell lung cancer.
  • Severe allergy to any monoclonal antibody.
  • Allergic to carboplatin or etoposide.
  • Recent heart attack or poorly controlled heart rhythm problems.
  • Pregnant or breastfeeding women.
  • History of drug abuse or addiction.
  • Any other condition that might cause the study to end early, as determined by the study doctor.

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