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

NCT03823118 | Completed Phase 2

• 1 other identifier: SALTER Trial
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

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.

Conditions

Small Cell Lung Cancer Recurrent

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (2)

• Overall survival (OS)

  Duration of time from the start of treatment to date of death, assessed up to 2 years

• Incidence of adverse events

  Up to 2 years

Study Arms (1)

S1/Anlotinib

EXPERIMENTAL

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

Interventions

S1/Anlotinib 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.

S1/Anlotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taizhou Hospital: lead

Study Sites (3)

Taizhou Hospital, Wenzhou Medical University

Taizhou, Zhejiang, 317000, China

Location

Enze Hospital

Taizhou, Zhejiang, China

Location

Sanmen People's Hospital

Taizhou, Zhejiang, China

Location

Related Publications (1)

• 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.

  PMID: 39333988 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Radiation Oncology

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: January 30, 2019
• Study Start: March 1, 2019
• Primary Completion: June 28, 2020
• Study Completion: April 17, 2021
• Last Updated: February 23, 2023

Record last verified: 2023-02

Locations

CN (3)