Clinical trial NCT03823118: S1 Plus Anlotinib in Treating Patients With Refractory or Relapsed Small-cell Lung Cancer
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Small Cell Lung Cancer Recurrent
Lead sponsor: Taizhou Hospital
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: each 21 days up to the toxicity or PD (up to 6 months)
measure: progression-free survival (PFS)
timeFrame: 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:
measure: Overall survival (OS)
timeFrame: Duration of time from the start of treatment to date of death, assessed up to 2 years
measure: Incidence of adverse events
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Taizhou
country: China
facility: Taizhou Hospital, Wenzhou Medical University
state: Zhejiang
city: Taizhou
country: China
facility: Enze Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Sanmen People's Hospital
state: Zhejiang
Study officials:
References: