S1 Plus Anlotinib in Treating Patients With Refractory or Relapsed Small-cell Lung Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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S1 Plus Anlotinib in Treating Patients With Refractory or Relapsed Small-cell Lung Cancer：An One-arm, Phase Ⅱ, Multi-center Clinical Study (SALTER TRIAL)

Conditions
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Small Cell Lung Cancer Recurrent

Intervention / Treatment
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* Drug: S1/Anlotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological or cytologically confirmed small cell lung cancer; Systemic chemotherapy that has previously received at least one or more lines regimen, followed by disease progression or recurrence; Age 18-75 years,ECOG PS:0-2,Life expectancy of more than 3 months participants had at least one measurable target lesion by RECIST1.1 The main organ function meets the following criteria:absolute value of neutrophils ≥ 1.5 × 109 / L, platelets ≥80 × 109 / L, hemoglobin ≥ 80 g / L;total bilirubin ≤ 1.5 times the upper limit of normal value, aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit of normal value (if liver metastasis, ≤ upper limit of normal value 5 times), serum creatinine ≤ 1.5 times the upper limit of normal; Patients should participate in the study voluntarily and sign informed consent Exclusion Criteria: Patients who have been used anti-angiogenesis inhibitors,such as (such as sunitinib,bevacizumab,endostar et al. Subjects with symptomatic brain metastases; Patients whose primary lesion with active bleeding within 4 months Hypertension, which is uncontrolled by the drug, is defined as: systolic blood pressure ≥ 160 mmHg, or diastolic blood pressure ≥ 100 mmHg Patients with active or unable to control serious infections Patients who are pregnant or breastfeeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: S1/Anlotinib<br>Anlotinib 12mg qd, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until maximum 6 cycles； 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. | Drug: S1/Anlotinib<br>* Anlotinib 12mg qd, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until maximum 6 cycles； 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Incidence of adverse events per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | Up to 2 years |