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

An Open-label, Phase II Single Arm Trial of Thoracic Radiotherapy for?ES-SCLC After First Line Treatment With Immune Checkpoint Inhibitors

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

Study Overview

• Status: Recruiting
• Conditions: SCLC,Extensive Stage
• Intervention / Treatment: Radiation: Thoracic radiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Min Fang; Phone Number: 13738152645; Email: fangmin@zjcc.org.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: Xiaojing Lai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TRT; Patients with es-SCLC after first line treatment with immune checkpoint inhibitors will be treated with thoracic radiotherapy.	Radiation: Thoracic radiotherapy; Thoracic radiotherapy for ES-SCLC after first line immunecheckpoint inhibitors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progress free survival	From the date of enrollment to the date of disease progression	2 years
Overall survival	from the date of enrollment until death by any cause or last follow-up	2 years

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Anticipated): August 30, 2024
• Study Completion (Anticipated): August 30, 2025

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: September 14, 2022
• First Posted (Actual): September 16, 2022

Study Record Updates

• Last Update Posted (Actual): September 16, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2022-TRT-SCLC-IIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No