Radiotherapy for advanced small-cell lung cancer after chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, single-arm Phase II study aims to evaluate the efficacy and safety of thoracic radiotherapy in patients with extensive-stage small-cell lung cancer (ES-SCLC) who have not progressed after receiving standard chemo-immunotherapy. Participants will receive thoracic radiotherapy alongside PD-1/PD-L1 maintenance therapy for a minimum of six months. The study focuses on patients with measurable thoracic lesions who meet specific eligibility criteria, including adequate organ function and performance status.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age between18 years and 80 years at time of study entry
2. ECOG performance status of 0 or 1
3. Body weight \>30 kg
4. Adequate bone marrow, liver and kidney function
5. Life expectancy of at least 3 months
6. At least one measurable (RECIST 1.1), thoracic lesion that can be irradiated with 45 Gy/15 fractions
7. Histologic or cytologic confirmation of small cell lung cancer
8. Stage III-IV disease (TNM v8)
9. Adequate pulmonary function with FEV1 \>1 L or \>30 % of predicted value and DLCO \>30 % of predicted value
10. 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 -

Exclusion Criteria:

1. Previous chemo-, immuno- or radiotherapy for SCLC
2. Major surgical procedure last 28 days
3. History of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis or HIV
4. Uncontrolled intercurrent illness
5. Other active malignancy
6. Leptomeningeal carcinomatosis
7. Immunosuppressive medication
8. Pregnant or breastfeeding women

Where it's running

• Ruijin Hospital, Shanghai jiaotong univestigy school of medicine
  Shanghai, Shanghai Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.