Phase II Trial of Consolidative Thoracic Radiotherapy for ES-SCLC After Standard Care of Chemo-immunotherapy

NCT05552846 | Recruiting

• 1 other identifier: 2021（212）
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single arm Phase II study designed to evaluate the efficacy and safety of thoracic radiotherapy for extensive-stage small-cell lung cancer treated with PD-1/PD-L1 plus etoposide platinum followed by PD-1/PD-L1 maintenance therapy

Conditions

Small-cell Lung Cancer

Keywords

thoradic radiotherapy; immune checkpoint inhibitors; chemo-immunotherapy

Outcome Measures

Primary Outcomes (1)

• 1-year progression-free survival

  PFS is defined as the period from the start of receiving the first EC/EP chemotherapy plus PD-1/PD-L1 inhibitor to disease progression.

  12 months after last patient entry

Secondary Outcomes (3)

• 1-year overall survival

  12 months after last patient entry

• toxicities

  12 months after last patient entry

• 5-year overall survival

  5-year after last patient entry

Study Arms (1)

experimental group

EXPERIMENTAL

chemo-immunotherapy followed by thoracic radiotherapy and PD-1/PD-L1 maintenance therapy

Radiation: thoracic radiotherapy

Interventions

thoracic radiotherapy RADIATION

Four courses of carboplatin/etoposide/anti-PD-1/PD-L1 every 3 weeks All the enrolled patients will be patients with ES-SCLC who did not have PD (determined as per the RECIST v1.1) after 6 cycle of platinum-based chemotherapy in combination with an anti-PD-1/L1. Then, thoracic radiotherapy of 45 Gy/15 fractions. PD-1/PD-L1 maintenance therapy concurrently and after thoracic radiotherapy at least more than 6 months, or until intolerable toxicity, progressive disease leading to a need for other treatment, or until the patient no longer wishes to continue treatment.

experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between18 years and 80 years at time of study entry
• ECOG performance status of 0 or 1
• Body weight \>30 kg
• Adequate bone marrow, liver and kidney function
• Life expectancy of at least 3 months
• At least one measurable (RECIST 1.1), thoracic lesion that can be irradiated with 45 Gy/15 fractions
• Histologic or cytologic confirmation of small cell lung cancer
• Stage III-IV disease (TNM v8)
• Adequate pulmonary function with FEV1 \>1 L or \>30 % of predicted value and DLCO \>30 % of predicted value
• Patients with brain metastases are eligible provided they are asymptomatic or treated and stable on steroids and/or anticonvulsants prior to the start of treatment -

You may not qualify if:

• Previous chemo-, immuno- or radiotherapy for SCLC
• Major surgical procedure last 28 days
• History of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis or HIV
• Uncontrolled intercurrent illness
• Other active malignancy
• Leptomeningeal carcinomatosis
• Immunosuppressive medication
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai jiaotong univestigy school of medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 23, 2022
• Study Start: January 30, 2021
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 19, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)