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

Taizhou Hospital

Status and phase: Completed; Phase 2

Conditions: Small Cell Lung Cancer Recurrent

Treatments: Drug: S1/Anlotinib

Study type: Interventional

Funder types: Other

Identifiers

NCT03823118

SALTER Trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

S1/Anlotinib

Experimental group

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.

Treatment:

Drug: S1/Anlotinib