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The purpose of this study is to assess the efficacy and safety of S1 combination with Anlotinib in patients with small cell lung cancer whose cancer has progression or recurrence after at least one standard chemotherapy.
Although SCLC is very responsive to initial treatment, most patients relapse with relatively resistant disease.These patients have a median survival of only 4 to 5 months when treated with further systemic therapy. Improvements in therapy for relapsed SCLC are much needed.The purpose of this study is to assess the efficacy and safety of S1 combination with Anlotinib in patients with small cell lung cancer whose cancer has progression or recurrence after at least one standard chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S1/Anlotinib | Experimental | Anlotinib 12mg qd, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until maximum 6 cyclesï¼› S1 60mg bid, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until it can not tolerate, or disease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S1/Anlotinib | Drug | Anlotinib 12mg qd, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until maximum 6 cyclesï¼› S1 60mg bid, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until it can not tolerate, or disease progression. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | measured by Response Evaluation Criteria in Solid Tumors version 1.1 | each 21 days up to the toxicity or PD (up to 6 months) |
| progression-free survival (PFS) | PFS will be estimated using standard Kaplan Meier survival analysis methods. | Duration of time from the start of treatment to the first documented disease progression according to RECIST 1.1 or death due to any cause, whichever occurs first, assessed up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | OS will be estimated using standard Kaplan Meier survival analysis methods. | Duration of time from the start of treatment to date of death, assessed up to 2 years |
| Incidence of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taizhou Hospital, Wenzhou Medical University | Taizhou | Zhejiang | 317000 | China | ||
| Enze Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39333988 | Derived | Wang W, Wu G, Luo W, Lin L, Zhou C, Yao G, Chen M, Wu X, Chen Z, Ye J, Yang H, Lv D. Anlotinib plus oral fluoropyrimidine S-1 in refractory or relapsed small-cell lung cancer (SALTER TRIAL): a multicenter, single-arm, phase II trial. BMC Cancer. 2024 Sep 27;24(1):1182. doi: 10.1186/s12885-024-12954-8. |
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Incidence of adverse events per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
| Up to 2 years |
| Taizhou |
| Zhejiang |
| China |
| Sanmen People's Hospital | Taizhou | Zhejiang | China |