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

Sponsor

Taizhou Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03823118

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

17.3

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Small Cell Lung Cancer Recurrent	Drug: S1/Anlotinib	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

52 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Mar 1, 2019

Anticipated Primary Completion Date :

Feb 28, 2020

Anticipated Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

Drug: S1/Anlotinib

Outcome Measures

Primary Outcome Measures

Objective Response Rate (ORR) [each 21 days up to the toxicity or PD (up to 6 months)]
measured by Response Evaluation Criteria in Solid Tumors version 1.1
progression-free survival (PFS) [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]
PFS will be estimated using standard Kaplan Meier survival analysis methods.

Secondary Outcome Measures

Overall survival (OS) [Duration of time from the start of treatment to date of death, assessed up to 2 years]
OS will be estimated using standard Kaplan Meier survival analysis methods.
Incidence of adverse events [Up to 2 years]
Incidence of adverse events per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taizhou Hospital, Wenzhou Medical University	Taizhou	Zhejiang	China	317000
2	Enze Hospital	Taizhou	Zhejiang	China
3	Sanmen People's Hospital	Taizhou	Zhejiang	China

Sponsors and Collaborators

Taizhou Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Haihua Yang, Head of Department of Radiation Oncology, Taizhou Hospital

ClinicalTrials.gov Identifier:

NCT03823118

Other Study ID Numbers:

SALTER Trial

First Posted:

Jan 30, 2019

Last Update Posted:

Apr 10, 2019

Last Verified:

Apr 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Neoplasms

Small Cell Lung Carcinoma

Study Results

No Results Posted as of Apr 10, 2019