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

Small Cell Lung Cancer Recurrent Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03823118
• Other study ID #: SALTER Trial
• Status: Completed
• Phase: Phase 2
• Start date: March 1, 2019
• Est. completion date: April 17, 2021

Study information

• Verified date: February 2023
• Source: Taizhou Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 17, 2021
• Est. primary completion date: June 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer Recurrent
• Small Cell Lung Carcinoma

Intervention

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.

Locations

Country	Name	City	State
China	Enze Hospital	Taizhou	Zhejiang
China	Sanmen People's Hospital	Taizhou	Zhejiang
China	Taizhou Hospital, Wenzhou Medical University	Taizhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Taizhou Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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
Secondary	Incidence of adverse events	Incidence of adverse events per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	Up to 2 years