NCT03823118

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Taizhou Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Small Cell Lung Cancer Recurrent

Interventions

Type	Name	Description
DRUG	S1/Anlotinib	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.

Timeline

• Start date: 2019-03-01
• Primary completion: 2020-06-28
• Completion: 2021-04-17
• First posted: 2019-01-30
• Last updated: 2023-02-23

Locations

3 sites across 1 country: China