Recurrent Small Cell Lung CancerPhase 2NCT03732846
Anlotinib in Treatment of Recurrent Small Cell Lung Cancer
A Phase 2 study testing Anlotinib in people with Recurrent Small Cell Lung Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
Exploring the efficacy and safety of Anlotinib in patients with relapsed small cell lung cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Small Cell Lung Cancer
- What is being tested?
- Anlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2018to 1 May 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old;
- Histological or cytologically confirmed small cell lung cancer;
- Systemic chemotherapy that has previously received at least two or more lines regimen, followed by disease progression or recurrence;
- According to the RECIST 1.1 standard, there is at least one measurable target lesion;
- ECOG physical score 0-1 points; expected survival time ≥ 3 months;
- The main organ function meets the following criteria:
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- blood routine: absolute value of neutrophils ≥ 1.5 × 109 / L, platelets ≥ 75 × 109 / L, hemoglobin ≥ 80 g / L;
- Blood biochemistry: 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;
- Subjects voluntarily joined the study and signed informed consent, with good adherence and follow-up.
Who cannot join
- Subjects who have previously used Anlotinib;
- Systematic anti-tumor treatments have been performed for the past 2 weeks, including chemotherapy, radiotherapy (except for metastatic lesions other than thoracic radiation), targeted therapy, immunotherapy, and biotherapy;
- Imaging (CT or MRI) shows central tumors in which tumor lesions invade local large blood vessels; imaging (CT or MRI) shows significant pulmonary cavitary or necrotizing tumors; or other factors identified by the investigator that may cause hemoptysis disease;
- A history of active bleeding within the first 6 months of screening, or receiving thrombolysis or anticoagulant therapy, or the investigator believes that there is a clear tendency to gastrointestinal bleeding (such as esophageal varices with bleeding risk, local activity) Ulcer lesions, etc.) or active hemoptysis;
- A thrombotic event occurs within 6 months (including arteriovenous thrombosis, pulmonary embolism, cerebrovascular accident, including transient ischemic attack, etc.);
- Cardiac diseases with obvious clinical symptoms, such as: congestive heart failure, coronary heart disease with obvious symptoms, arrhythmia with difficult drug control (including clinically significant QTc interval prolongation history, or screening period QTc interval women >470ms, Male > 450ms), had myocardial infarction within 6 months, or cardiac insufficiency;
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- Hypertension, which is uncontrolled by the drug, is defined as: systolic blood pressure ≥ 160 mmHg, or diastolic blood pressure ≥ 100 mmHg;
- Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or patients with total gastrectomy;
- Surgery (<28 days) before the study was selected or the surgical incision did not completely heal, or there were other unhealed wounds;
- Active or uncontrolled serious infections;
- Pregnant or lactating women; those who have fertility are unwilling or unable to take effective contraceptive measures;
- Increasing the risk associated with participating in a study or study drug, and at the discretion of the investigator, may lead to other conditions in which the patient is not eligible for inclusion in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jian Fang, +86-010-88196459, bcht2_mj@163.com
Di Wu, +86-010-88196459, lucia8810@sina.com
About this study
Official title: One-arm, Phase II, Single-center Clinical Study of Anlotinib in the Treatment of Recurrent Small Cell Lung Cancer
Exploring the efficacy and safety of Anlotinib in patients with relapsed small cell lung cancer
Read the detailed description
This is an one-arm, phase II, single-center clinical study of Anlotinib in the treatment of recurrent small cell lung cancer, the objection is to exploring the efficacy and safety of Anlotinib in patients with relapsed small cell lung cancer.It is going to enroll 43 patients.
- Conditions
- Recurrent Small Cell Lung Cancer
- Being tested
- Anlotinib
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnlotinibDrug
Take Anlotinib 12mg once daily for two weeks, stop for one week, the program repeats every 21 days until it can not tolerate, or disease progression
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib | Experimental | Take Anlotinib 12mg once daily for two weeks, stop for one week, the program repeats every 21 days until it can not tolerate, or disease progression. Receives: Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS (Progression-Free survival)
From the date Into this study (signed ICF) to tumor progression or death for any reason.
Measured: From the date Into this study (signed ICF) to tumor progression or death for any reason, up to 18 months.
Secondary outcomes (3)
OS (Overall survival)
From the date Into this study (signed ICF) to death for any reason.
Measured: From the date Into this study (signed ICF) to death for any reason, up to 18months.
DCR (Disease control rate)
The rate of CR, PR plus SD
Measured: From the beginning of treatment, CT and ultrasound examinations are performed every six weeks to assess changes in the disease until the disease progression or death, up to 18 months.
ORR (Objective control rate)
The rate of CR and PR
Measured: From the beginning of treatment, CT and ultrasound examinations are performed every six weeks to assess changes in the disease until the disease progression or death, up to 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start1 Nov 2018
- Primary completion1 May 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- 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
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Fang, Peking University Cancer Hospital & Institute
- Investigators
- Jian Fang, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732846
- Sponsor's protocol ID
- ALTN-SCLC-BCH
- Status last verified
- Nov 2018
- First submitted
- 29 Oct 2018
- Last updated
- 7 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-arm, Phase II, Single-center Clinical Study of Anlotinib in the Treatment of Recurrent Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03732846
- Acronym / sponsor ID
- ALTN-SCLC-BCH
- Conditions
- Recurrent Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 7 Nov 2018 (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.
Exploring the efficacy and safety of Anlotinib in patients with relapsed small cell lung cancer
Detailed description
This is an one-arm, phase II, single-center clinical study of Anlotinib in the treatment of recurrent small cell lung cancer, the objection is to exploring the efficacy and safety of Anlotinib in patients with relapsed small cell lung cancer.It is going to enroll 43 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anlotinib | Experimental | Drug: AnlotinibTake Anlotinib 12mg once daily for two weeks, stop for one week, the program repeats every 21 days until it can not tolerate, or disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years old;
- Histological or cytologically confirmed small cell lung cancer;
- Systemic chemotherapy that has previously received at least two or more lines regimen, followed by disease progression or recurrence;
- According to the RECIST 1.1 standard, there is at least one measurable target lesion;
- ECOG physical score 0-1 points; expected survival time ≥ 3 months;
Key exclusion criteria (12 listed)
- Subjects who have previously used Anlotinib;
- Systematic anti-tumor treatments have been performed for the past 2 weeks, including chemotherapy, radiotherapy (except for metastatic lesions other than thoracic radiation), targeted therapy, immunotherapy, and biotherapy;
- Imaging (CT or MRI) shows central tumors in which tumor lesions invade local large blood vessels; imaging (CT or MRI) shows significant pulmonary cavitary or necrotizing tumors; or other factors identified by the investigator that may cause hemoptysis disease;
- A history of active bleeding within the first 6 months of screening, or receiving thrombolysis or anticoagulant therapy, or the investigator believes that there is a clear tendency to gastrointestinal bleeding (such as esophageal varices with bleeding risk, local activity) Ulcer lesions, etc.) or active hemoptysis;
- A thrombotic event occurs within 6 months (including arteriovenous thrombosis, pulmonary embolism, cerebrovascular accident, including transient ischemic attack, etc.);
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 |
|---|---|---|
| AnlotinibTake Anlotinib 12mg once daily for two weeks, stop for one week, the program repeats every 21 days until it can not tolerate, or disease progression | Drug | Anlotinib |
Primary outcome
PFS (Progression-Free survival)
Time frame: From the date Into this study (signed ICF) to tumor progression or death for any reason, up to 18 months.
From the date Into this study (signed ICF) to tumor progression or death for any reason.
3 secondary outcomes
OS (Overall survival)
Time frame: From the date Into this study (signed ICF) to death for any reason, up to 18months.
DCR (Disease control rate)
Time frame: From the beginning of treatment, CT and ultrasound examinations are performed every six weeks to assess changes in the disease until the disease progression or death, up to 18 months.
ORR (Objective control rate)
Time frame: From the beginning of treatment, CT and ultrasound examinations are performed every six weeks to assess changes in the disease until the disease progression or death, up to 18 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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.
Jian Fang principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib in people with Recurrent Small Cell Lung Cancer, run by Peking University Cancer Hospital & Institute at 1 site 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 9 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Di Wu (010-88196478, lucia8810@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (Progression-Free survival) (time frame: From the date Into this study (signed ICF) to tumor progression or death for any reason, up to 18 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2018; AzTrials last refreshed its copy on 8 Nov 2026.