TRT for ES-SCLC After First Line Treatment With Immune Checkpoint Inhibitors

Launched by ZHEJIANG CANCER HOSPITAL · Sep 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the use of thoracic radiotherapy, a type of targeted radiation treatment, for patients with extensive stage small cell lung cancer (ES-SCLC) who have already received initial treatment with immune checkpoint inhibitors and chemotherapy. The goal is to evaluate how safe and effective this additional treatment is for improving patient outcomes.

To be eligible for the trial, participants must be at least 18 years old and have a good performance status, meaning they are relatively healthy and can carry out daily activities. They should have no signs of cancer progression after receiving four doses of immunotherapy combined with chemotherapy and must have some remaining cancer in the chest area. Participants will need to meet certain health criteria and agree to use effective birth control during the trial. Those who are pregnant, have other active cancers, or certain severe health issues may not qualify. If you decide to join, you will receive further details about what to expect during the trial, including the treatment and follow-up care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age at least 18 years.
• • ECOG PS 0-1.
• • Histological or cytological syndrome of small cell lung cancer, imaging evaluation staging is extensive
• • Life expectancy \>= 3 months.
• • Patients are non-progressed after 4 dosed of immunotherapy plus platinum based chemotherapy, with residual thoracic lesions
• • Palliative radiotherapy were allowed except for TRT, the interval \> 4 weeks
• * Adequate organ function prior to enrollment:
• • Adequate bone marrow function: white blood cell (WBC) count ≥ 3.0 \* 10 \^ 9/L or neutrophil count ≥ 1.5 \* 10 \^ 9/L, platelet count ≥ 100 \* 10 \^ 9/L and hemoglobin ≥90g/L,;
• • Adequate hepatic function: total bilirubin, urea nitrogen and serum creatinine≤ 1.5 x upper limit of normal (ULN). Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.0 ULN;
• • Sufficient heart and lung function, EF\>55%FEV1\>50%
• • Ability to understand and willingness to provide the informed consent.
• • Women of childbearing age and men must agree to use effective contraception during the trial.
• Exclusion Criteria:
• • History of another malignancy or concurrent malignancy;
• • Mixed small cell with non-small cell lung cancer histology;
• • History of thoracic radiotherapy;
• • Malignant pleural or ascites;
• • Patients with leptomeningeal metastasis or uncontrolled brain;
• • Severe autoimmune disease: inflammatory bowel disease (including Crohn's disease and ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Wegener's granulomatosis and related vasculitides.
• • Symptomatic interstitial lung disease or clinically active infectious/non-infectious pneumonitis.
• • Active infection, congestive heart failure, or any evidence of myocardial infarction, unstable angina pectoris or cardiac arrhythmia within 6 months prior to enrollment.
• • The patient is pregnant (confirmed by serum b-HCG if applicable) or is breastfeeding.
• • Mental disorders, drug abuse, and social condition that may negatively impact compliance in the investigator's opinion.