Clinical trial · Interventional
S1 Plus Anlotinib in Treating Patients With Refractory or Relapsed Small-cell Lung Cancer
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)
NCT03823118CI-TRIAL-00064215completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| S1/Anlotinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- S1/Anlotinib
- description
- 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.
- interventionNames
- Drug: S1/Anlotinib
Primary outcomes (2)
- measure
- Objective Response Rate (ORR)
- timeFrame
- each 21 days up to the toxicity or PD (up to 6 months)
- description
- measured by Response Evaluation Criteria in Solid Tumors version 1.1
- measure
- progression-free survival (PFS)
- timeFrame
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDWang 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. PMID 39333988