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

NCT05544149 | Unknown Phase 2

• 1 other identifier: 2022-TRT-SCLC-IIT
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

SCLC,Extensive Stage

Outcome Measures

Primary Outcomes (2)

• Local recurrence free survival

  From the date of enrollment to the date of local recurrence

  2 years

• Adverse events

  Treatment-related adverse events according to CTCAE 5.0.

  2 years

Secondary Outcomes (2)

• Progress free survival

  2 years

• Overall survival

  2 years

Study Arms (1)

TRT

EXPERIMENTAL

Patients with es-SCLC after first line treatment with immune checkpoint inhibitors will be treated with thoracic radiotherapy.

Radiation: Thoracic radiotherapy

Interventions

Thoracic radiotherapy RADIATION

Thoracic radiotherapy for ES-SCLC after first line immunecheckpoint inhibitors

TRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Study Officials

• Xiaojing Lai

  Department of Thoracic Radiotherapy, Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaojing Lai

CONTACT

13819480002; laixj@zjcc.org.cn

Min Fang

CONTACT

13738152645; fangmin@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 16, 2022
• Study Start: September 1, 2022
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2025
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)