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

Study Overview
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Brief Summary
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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

Detailed Description
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This study a single arm prospective phase II study. All the enrolled patients will be patients with ES-SCLC who did not have PD (determined as per the RECIST v1.1) after 4 cycle of platinum-based chemotherapy in combination with an anti-PD-1/L1. Then, those enrolled patients would be treated with thoracic radiotherapy concurrently with PD-1/PD-L1 maintenance therapy, and the total maintenance therapy time should at least more than 6 months.

Official Title
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Consolidative Thoracic Radiotherapy for Extensive-stage Small-cell Lung Cancer Treated With Chemo-immunotherapy Followed by PD-1/PD-L1 Maintenance Therapy：an Open Label, Single Arm Prospective Trial

Conditions
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Small-cell Lung Cancer

Intervention / Treatment
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* Radiation: thoracic radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 - Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>chemo-immunotherapy followed by thoracic radiotherapy and PD-1/PD-L1 maintenance therapy | Radiation: thoracic radiotherapy<br>* 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 4 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year overall survival |  | 12 months after last patient entry | 
| toxicities | Number of participants with treatment-related adverse events and the grade of adverse events as assessed by CTCAE v4.0 | 12 months after last patient entry | 
| 5-year overall survival |  | 5-year after last patient entry | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thoradic radiotherapy, immune checkpoint inhibitors, chemo-immunotherapy