Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT05552846

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

Led by Ruijin Hospital · Updated on 2024-09-19

104

Participants Needed

1

Research Sites

295 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 years and 80 years at time of study entry
  • ECOG performance status of 0 or 1
  • Body weight greater than 30 kg
  • Adequate bone marrow, liver, and kidney function
  • Life expectancy of at least 3 months
  • At least one measurable thoracic lesion suitable for 45 Gy/15 fractions radiotherapy
  • Histologic or cytologic confirmation of small cell lung cancer
  • Stage III-IV disease (TNM version 8)
  • Adequate pulmonary function with FEV1 >1 L or >30% of predicted value and DLCO >30% of predicted value
  • Patients with brain metastases eligible if asymptomatic or stable on treatment prior to study start
Not Eligible

You will not qualify if you...

  • Previous chemotherapy, immunotherapy, or radiotherapy for small-cell lung cancer
  • Major surgery within the last 28 days
  • History of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis, or HIV
  • Uncontrolled intercurrent illness
  • Other active malignancy
  • Leptomeningeal carcinomatosis
  • Use of immunosuppressive medication
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ruijin Hospital, Shanghai jiaotong univestigy school of medicine

Shanghai, Shanghai Municipality, China, 200025

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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