Small Cell Lung Cancer RecurrentPhase 2NCT03823118
S1 Plus Anlotinib in Treating Patients With Refractory or Relapsed Small-cell Lung Cancer
A Phase 2 study testing S1/Anlotinib in people with Small Cell Lung Cancer Recurrent, run by Taizhou Hospital at 3 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Cancer Recurrent
- What is being tested?
- S1/Anlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesChina
- Study dates
- 1 Mar 2019to 17 Apr 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Taizhou Hospital, Wenzhou Medical University
Taizhou, Zhejiang, 317000
Enze Hospital
Taizhou, Zhejiang
Sanmen People's Hospital
Taizhou, Zhejiang
About this study
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)
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.
Read the 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
- Being tested
- S1/Anlotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S1/AnlotinibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: S1/Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
measured by Response Evaluation Criteria in Solid Tumors version 1.1
Measured: 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.
Measured: 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)
OS will be estimated using standard Kaplan Meier survival analysis methods.
Measured: Duration of time from the start of treatment to date of death, assessed up to 2 years
Incidence of adverse events
Incidence of adverse events per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start1 Mar 2019
- Primary completion28 Jun 2020
- Study completion17 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Cell Lung Cancer RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taizhou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haihua Yang, Taizhou Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823118
- Sponsor's protocol ID
- SALTER Trial
- Status last verified
- Feb 2023
- First submitted
- 28 Jan 2019
- Last updated
- 23 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39333988
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03823118
- Acronym / sponsor ID
- SALTER Trial
- Conditions
- Small Cell Lung Cancer Recurrent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Taizhou HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 28 Jun 2020 (actual)
- Study completion
- 17 Apr 2021 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S1/Anlotinib | Experimental | Drug: S1/AnlotinibAnlotinib 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S1/AnlotinibAnlotinib 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 |
Primary outcome
Objective Response Rate (ORR)
Time frame: 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)
Time frame: 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.
2 secondary outcomes
Overall survival (OS)
Time frame: Duration of time from the start of treatment to date of death, assessed up to 2 years
Incidence of adverse events
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Derived from this study: PubMed 39333988Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S1/Anlotinib in people with Small Cell Lung Cancer Recurrent, run by Taizhou Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: each 21 days up to the toxicity or PD (up to 6 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03823118, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.