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

NCT ID: NCT03823118

Last Updated: 2023-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2021-04-17

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

S1/Anlotinib

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taizhou Hospital

OTHER

Sponsor Role: lead

Responsible Party

Haihua Yang

Head of Department of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Taizhou Hospital, Wenzhou Medical University

Taizhou, Zhejiang, China

Enze Hospital

Taizhou, Zhejiang, China

Sanmen People's Hospital

Taizhou, Zhejiang, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 39333988 (View on PubMed)

Other Identifiers

SALTER Trial

Identifier Type: -

Identifier Source: org_study_id