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

University of Chinese Academy Sciences

Status and phase

Enrolling

Phase 2

Conditions

SCLC,Extensive Stage

Treatments

Radiation: Thoracic radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

2022-TRT-SCLC-IIT

Details and patient eligibility

About

To Evaluate the Safety and Efficacy of Thoracic Radiotherapy for?ES-SCLC After First Line Treatment with Immune Checkpoint Inhibitors.

Enrollment

42 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.