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| Name | Class |
|---|---|
| Hunan Cancer Hospital | OTHER |
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Etoposide-cisplatin/ -carboplatin in combination with PD-L1 inhibitor for 4 cycles followed by maintenance therapy with PD-L1 inhibitor is currently the world-wide first-line treatment for extensive-stage small cell lung cancer. When 4 cycles of EC/EP chemotherapy combined with PD-L1 inhibitor are effective, guidelines recommend additional thoracic radiotherapy.
In our study, the investigators bring radiotherapy forward, which means that after 2 cycles of EC/EP chemotherapy plus Atezolizumab, participants with response(PR/CR/SD)will receive concurrent radiotherapy and 2 cycles of EC/EP chemotherapy plus Atezolizumab, then maintenance therapy with Atezolizumab (Q3W).
The purpose of this study is to explore the safety and efficacy of Atezolizumab combined with concurrent chemoradiotherapy in untreated participants with extensive-stage small cell lung cancer.
participants receive EC/EP chemotherapy combined with Atezolizumab for 2 cycles, and the efficacy will be evaluated. If the efficacy evaluation is SD/PR/CR, concurrent chemoradiotherapy comined with EC/EP(2 cycles) +Atezolizumab will be initiated. After concurrent chemoradiotherapy +Atezolizumab, Atezolizumab was maintained until PD or intolerance or for at most 2 years.
participants with brain metastases will receive radiotherapy for brain metastases during the first 2 cycles of chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (etoposide, cisplatin, carboplatin, radiation, Atezolizumab) | Experimental | Participants receive EC/EP chemotherapy combined with Atezolizumab( PD-L1 inhibitor)for 2 cycles, and the efficacy is evaluated 2 weeks after the treatment. If the efficacy evaluation is SD/PR/CR, concurrent chemoradiotherapy with EC/EP(2 cycles) + Atezolizumab) will be initiated. After concurrent chemoradiotherapy+ Atezolizumab, Atezolizumab was maintained until PD or intolerance or for at most 2 years. Participants with brain metastases will receive radiotherapy forbrain metastases during the first 2 cycles of chemotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation Therapy | Procedure | Thoracic Radiation Dose: 3Gy, QD, total dose: 30-45Gy; Particpants with brain metastases:metastatic lesions≤3:whole brain radiotherapy with local simultaneous PGTV:50Gy/10F;metastatic lesions>3:whole brain radiotherapy PTV:30Gy/10F. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events and the grade of adverse events as assessed by CTCAE v4.0. | 0-36month |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1 | PFS is defined as the period from the start of receiving the first EC/EP chemotherapy plus PD-L1 inhibitor to disease progression.PFS is assessed by the Investigator Using RECIST v1.1. | 0-120 months |
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Inclusion Criteria:
1.Histologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system) 2.Must sign a written informed consent form prior to any study specific procedures 3. No prior treatment for ES-SCLC 4.Measurable disease, as defined by RECIST v1.1 5.Can tolerate radiotherapy, no contraindication of radiotherapy 6.Weight≥40kg 7.Life expectancy>12 weeks 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1. 9.Systemic immunosuppressive doses of corticosteroids (prednisone>10 mg/d or equivalent) was discontinued at least 2 weeks before registration for protocol therapy.
10. Be willing to provide 20 tissue sections(4-6 micron thickness) from a newly obtained core or excisional biopsy of a tumor lesion, for biomarker exploration; newly-obtained is defined as a specimen obtained within 3 months before initiation of treatment on day 1; newly-obtained samples must be core needle biopsy, excision, or incision 11.Must have adequate organ function defined by the following laboratory results:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan cancer hospital | Changsha | Hunan | 410000 | China | ||
| the second Xiangya hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37350968 | Derived | Liu C, Zeng L, Deng C, Jiang W, Wang Y, Zhou Y, Liu L, Wang S, Zhou C, Qiu Z, Zeng F, Wu F, Weng J, Liu X, Yang N, Ma F. Hypofractionated radiotherapy with immunochemotherapy for extensive-stage small-cell lung cancer. Front Immunol. 2023 Jun 7;14:1175960. doi: 10.3389/fimmu.2023.1175960. eCollection 2023. |
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To assess safety and tolerability of Atezolizumab Combined with Concurrent Chemoradiotherapy and maintenance therapy with Atezolizumab in untreated participants with extensive-disease small cell lung cancer.
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| Changsha |
| Hunan |
| 410000 |
| China |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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