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

Recruiting now · Not applicable

Conditions studied: Small-cell Lung Cancer

In brief

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

Key facts

Study ID

NCT05552846

Run by

Ruijin Hospital

People needed

104

Starts

2021-01-30

Expected to finish

2026-09-30

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Ruijin Hospital, Shanghai jiaotong univestigy school of medicine — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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