NCT05544149UnknownPhase 2
An Open-label, Phase II Single Arm Trial of Thoracic Radiotherapy for?ES-SCLC After First Line Treatment With Immune Checkpoint Inhibitors
Zhejiang Cancer Hospital1 site in 1 country42 target enrollmentStarted: September 1, 2022Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Zhejiang Cancer Hospital
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Adverse events
Study Overview
Brief Summary
To Evaluate the Safety and Efficacy of Thoracic Radiotherapy for?ES-SCLC After First Line Treatment with Immune Checkpoint Inhibitors.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age at least 18 years.
- •ECOG PS 0-
- •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.
Arms & Interventions
TRT
Experimental
Patients with es-SCLC after first line treatment with immune checkpoint inhibitors will be treated with thoracic radiotherapy.
Intervention: Thoracic radiotherapy (Radiation)
Outcomes
Primary Outcomes
Adverse events
Time Frame: 2 years
Treatment-related adverse events according to CTCAE 5.0.
Local recurrence free survival
Time Frame: 2 years
From the date of enrollment to the date of local recurrence
Secondary Outcomes
- Overall survival(2 years)
- Progress free survival(2 years)
Investigators
Xiaojing Lai
Clinical Professor
Zhejiang Cancer Hospital
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Not Applicable
Phase II Trial of Consolidative Thoracic Radiotherapy for ES-SCLC After Standard Care of Chemo-immunotherapySmall-cell Lung CancerNCT05552846Ruijin Hospital104
Recruiting
Phase 2
First-line Treatment for ES-SCLC with Chemotherapy Combined with PD-1/PD-L1 Inhibitor Sequential Thoracic RadiotherapyExtensive-stage Small-cell Lung CancerNCT06586697Henan Cancer Hospital47
Recruiting
Phase 1
Phase I/II Trial in ES-SCLC to Enhance Response to Atezolizumab Plus Chemotherapy With Total Body IrradiationStage IV Lung CancerExtensive Stage Lung Small Cell CarcinomaNCT06110572Vanderbilt-Ingram Cancer Center18
Recruiting
Phase 1
Thoracic Consolidation Radiotherapy for ES-SCLC Treated With Chemo-immunotherapySmall Cell Lung Cancer Extensive StageNCT06187740Fudan University28
Terminated
Phase 2
Concurrent EGFR-TKIs and Thoracic Radiation Therapy in Active EGFR Mutation for 1st Line Treatment of Stage IV NSCLCNon Small Cell Lung CancerNCT02353741Xinqiao Hospital of Chongqing10