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Small Cell Lung cancer (SCLC) is a highly aggressive tumor that accounts for about 15 percent of all lung cancer cases. SCLC disease progresses rapidly, and about 2/3 of the patients have extensive stage (ES-SCLC) at the time of diagnosis, with extremely poor prognosis. However, the overall survival (OS) of ES-SCLC patients was not significantly prolonged, with platinum combined with etoposide chemotherapy as the standard treatment. In recent years, the emergence of Immune checkpoint inhibitor (ICI) has made the treatment of ES-SCLC appear at the dawn. In Impower133 study, Atezolizumab combined with chemotherapy significantly prolonged OS(median OS 12.3 months vs 10.3 months, HR=0.70, 95%CI 0.54-0.91, P = 0.007). Durvalumab combined with chemotherapy (CASPIAN study) is the first study in 20 years in which the total survival time of ES-SCLC treated by first-line therapy is 13 months, and there is no significant increase in adverse reactions compared with chemotherapy. Therefore, in 2019, NCCN also recommended Atezolizumab or Durvalumab+ EC regimens as a category 1 preferred option for first-line treatment of ES-SCLC.
Small Cell Lung cancer (SCLC) is a highly aggressive tumor that accounts for about 15 percent of all lung cancer cases. SCLC disease progresses rapidly, and about 2/3 of the patients have extensive stage (ES-SCLC) at the time of diagnosis, with extremely poor prognosis. However, the overall survival (OS) of ES-SCLC patients was not significantly prolonged, with platinum combined with etoposide chemotherapy as the standard treatment. In recent years, the emergence of Immune checkpoint inhibitor (ICI) has made the treatment of ES-SCLC appear at the dawn. In Impower133 study, Atezolizumab combined with chemotherapy significantly prolonged OS(median OS 12.3 months vs 10.3 months, HR=0.70, 95%CI 0.54-0.91, P = 0.007). Durvalumab combined with chemotherapy (CASPIAN study) is the first study in 20 years in which the total survival time of ES-SCLC treated by first-line therapy is 13 months, and there is no significant increase in adverse reactions compared with chemotherapy. Therefore, in 2019, NCCN also recommended Atezolizumab or Durvalumab+ EC regimens as a category 1 preferred option for first-line treatment of ES-SCLC.
Although THE TMB of SCLC is higher in solid tumors, the objective remission rate (ORR) of SCLC using PD-1 or PD-L1 inhibitors is slightly lower than that of non-small cell lung cancer, and frequent drug resistance becomes the bottleneck of treatment. Some recent studies have shown that anti-angiogenesis drugs can also reverse the immunosuppressive state of tumor microenvironment while anti-tumor therapy, and improve the efficacy of ICI, so as to play a synergistic role. Therefore, anti-angiogenesis therapy combined with immunotherapy is expected to be a new strategy for the treatment of SCLC. Amlotinib is a multi-target anti-angiogenic drug, which has been approved for third-line treatment of SCLC with mild adverse reactions. Anlotinib combined with Durvalumab may have a synergistic antitumor effect, but no studies have been reported so far. Therefore, on the basis of the CASPIAN research study, we designed the Durvalumab + chemotherapy + ernesto, first-line treatment for extensive stage small cell lung cancer with single arm, open, multicenter, phase II clinical research, expected in domestic five cancer center, into the group of 120 ES - SCLC patients with untreated, research Durvalumab + chemotherapy + ROM for efficacy and safety of Ann, and further explore the curative effect of predictive biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outcome of Durvalumab-Etoposide-platinum in untreated ES-SCLC(CASPIAN trial) | Other | The outcome of CASPIAN |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib Plus Durvalumab-Platinum-Etoposide in First-line Treatment Extensive Small-cell Lung Cancer | Drug | This trial is single-armed IIb stage clinical trial to study the efficacy and safety of Alotinib Plus Durvalumab-Platinum-Etoposide in First-line Treatment Extensive Small-cell Lung Cancer . We use the outcome of CASPIAN trial as control group. The primary endpoint is ORR according to the RECIST 1.1, and secondary endpoints are PFS, OS, satety and life quality. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | From date of the first dose of induction to date of objective disease progression or death, whichever came first, | Assessed up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR ) | Proportion of patients with reduction in stable in tumor burden of a predefined amount,Baseline until partial response (PR) or complete response (CR), whichever occurs first,assessed up to 12 months | From the date of first dose until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 60 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanqiu Zhao, MS | Henan Tumor Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sixth People's Hospital of Luoyang | Luoyang | Henan | 471000 | China | ||
| Henan Tumor Hospital |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
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| Disease Control Rate (DCR) | Proportion of patients with reduction in stable in tumor burden of a predefined amount,Baseline until partial response (PR) ,complete response (CR) or stable disease (SD), whichever occurs first,assessed up to 12 months | From the date of first dose until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 60 months. |
| overall survival (OS ) | Time from the first treatment to death from any cause or the end of the study | From date of randomization until the date of first documented date of death from any cause, assessed up to 60 months |
| Time To Response (TTR) | Time from the initiation of treatment to the first observation of disease response | Up to 60 months |
| Duration of response (DoR) | Time from first documented evidence of CR or PR until PD or death, whichever occurred first | Up to 60 month |
| PFS Rate | The percentage of participants with no progression or death at 12 or 24 months | UP to 60 months |
| OS rate | The percentage of participants still alive at 12 or 24 months | Up to 60 months |
| Safety | Adverse events (AEs) were monitored and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0). | Up to 60 months |
| Zhengzhou |
| Henan |
| 450000 |
| China |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |