Small Cell Lung CancerPhase 3NCT03651219
Mesylate Apatinib Combined With Irinotecan in Treatment of Recurrent Small Cell Lung Cancer
A Phase 3 study testing Apatinib and Irinotecan in people with Small Cell Lung Cancer, run by Beijing Chest Hospital.
Trial summary
The aim of the study is to evaluate the safety and efficacy of apatinib mesylate tablets and chemotherapy drug Irinotecan in treatment of recurrent SCLC stage IIIB\&IV patients. It is a randomized controlled clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Apatinib and Irinotecan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 8 Sep 2018to 8 Aug 2020
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Locally advanced/metastatic small lung cancer (IIIb / IV) confirmed by pathology with measurable lesions ；
- Patients was treated by platinum chemotherapy drugs and was diagnosed to PD；
- ECOG：0-2；
- Anticipated survival time more than 3 months；
- Fertile woman must perform a pregnancy test (serum or urine) 7 days before screened, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib. For man, surgical sterilization should be performed, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib；
- Patients voluntarily entered the study and signed informed consent form (ICF).
- The function in main organs of patients is normal.
Who cannot join
- Blend cancer type with NSCLC or else；
- Brain MRI, CT or venography confirmed that there are brain hemorrhage symptoms;
- MRI, CT or venography confirmed that tumor invaded big vessels;
- Patients with uncontrollable hypertension (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg, despite optimal drug therapy).；
- Patients with with grade Ⅱ myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male ≥ 450 ms, female ≥470 ms)；
- Abnormal coagulation (INR>1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or receiving coagulation therapy;
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- Urine protein≥++, or urine protein in 24 hours≥1.0g;
- Received big surgery, had bone fracture or ulcer in 4 weeks;
- Unhealed bone fracture or wound for long time;
- Patients with active hepatitis B virus or hepatitis C virus infection；
- Patients who received systemic antibiotic treatment of serious infections;
- Pregnant and lactational woman or patients do not receive contraception;
- Patients who are prone to bleed or use anticoagulant drugs.
- Patients who have other uncured malignant tumors.
- Patients who experienced bleeding symptoms of clinical significance within 3 months before screening, or with confirmed bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer, baseline occult blood in stool ++ and above, or vasculitis, etc；
- Random 12 months before the artery/vein thrombosis events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.；
- Known history of hypersensitivity to apatinib or any of it components.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Mesylate Apatinib Combined With Irinotecan in Treatment of Recurrent Small Cell Lung Cancer: A Randomized Controlled Clinical Trial
The aim of the study is to evaluate the safety and efficacy of apatinib mesylate tablets and chemotherapy drug Irinotecan in treatment of recurrent SCLC stage IIIB\&IV patients. It is a randomized controlled clinical trial.
Read the detailed description
Apatinib mesylate is a new inhibitor of VEGFR-2 tyrosine kinase targeting the intracellular ATPbinding site of the receptor.
This research needs participants satisfied following criteria:
- Aged between 18 and 70；
- Locally advanced/metastatic small lung cancer (IIIB/IV) confirmed by pathology with measurable lesions；
- Patients who was treated by platinum chemotherapy drugs（including sensitive recurrency and resistant recurrency）
- ECOG：0-2；
- the function of primary organs is normal.
- Patients voluntarily entered the study and signed informed consent form (ICF).
The primary goal of this research choose ORR, DCR and adverse effects as main curative effect criteria. PFS, OS and QoL as secondary curative effect criteria.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Apatinib, Irinotecan
- Keywords
- SCLC, apatinib, Irinotecan
- 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.
ApatinibDrug
Apatinib Mmesylate tablets 250mg/d, po, there's totally 4-6 cycles(21days per cycle)
IrinotecanDrug
Irinotecan 80mg/m2 d1, d8, vi, there's totally 4-6 cycles(21days per cycle)
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Patients use Apatinib Mesylate tablets combined with Irinotecan. Receives: Drug: Apatinib; Drug: Irinotecan |
| controlled group | Active comparator | Patients use Irinotecan Receives: Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of treatment
time from take apatinib to withdrawal from experiment due to adverse reaction of apatinib
Measured: two years
Secondary outcomes (1)
progress free survival and overall survival
Secondary study endpoint
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start8 Sep 2018 (estimated)
- Primary completion8 Aug 2019 (estimated)
- Study completion8 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- experimental group: Irinotecan 80mg/m2 d1,d8 vi, apatinib mesylate tablets(250mg/d) po, 4-6 cycle（21d per cycle）; controlled group: Irinotecan 80mg/m2 d1,d8 vi, 4-6 cycle（21d per cycle）;
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651219
- Sponsor's protocol ID
- 20171301
- Status last verified
- Aug 2018
- First submitted
- 3 Aug 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesylate Apatinib Combined With Irinotecan in Treatment of Recurrent Small Cell Lung Cancer: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03651219
- Acronym / sponsor ID
- 20171301
- Conditions
- Small Cell Lung Cancer
- Keywords
- SCLC, apatinib, Irinotecan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Beijing Chest HospitalUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 8 Sep 2018 (estimated)
- Primary completion
- 8 Aug 2019 (estimated)
- Study completion
- 8 Aug 2020 (estimated)
- First posted
- 29 Aug 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.
The aim of the study is to evaluate the safety and efficacy of apatinib mesylate tablets and chemotherapy drug Irinotecan in treatment of recurrent SCLC stage IIIB\&IV patients. It is a randomized controlled clinical trial.
Detailed description
Apatinib mesylate is a new inhibitor of VEGFR-2 tyrosine kinase targeting the intracellular ATPbinding site of the receptor.
This research needs participants satisfied following criteria:
- Aged between 18 and 70；
- Locally advanced/metastatic small lung cancer (IIIB/IV) confirmed by pathology with measurable lesions；
- Patients who was treated by platinum chemotherapy drugs（including sensitive recurrency and resistant recurrency）
- ECOG：0-2；
- the function of primary organs is normal.
- Patients voluntarily entered the study and signed informed consent form (ICF).
The primary goal of this research choose ORR, DCR and adverse effects as main curative effect criteria. PFS, OS and QoL as secondary curative effect criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- experimental group: Irinotecan 80mg/m2 d1,d8 vi, apatinib mesylate tablets(250mg/d) po, 4-6 cycle（21d per cycle）; controlled group: Irinotecan 80mg/m2 d1,d8 vi, 4-6 cycle（21d per cycle）;
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Apatinib, Drug: IrinotecanPatients use Apatinib Mesylate tablets combined with Irinotecan. |
| controlled group | Active comparator | Drug: IrinotecanPatients use Irinotecan |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Locally advanced/metastatic small lung cancer (IIIb / IV) confirmed by pathology with measurable lesions ；
- Patients was treated by platinum chemotherapy drugs and was diagnosed to PD；
- ECOG：0-2；
- Anticipated survival time more than 3 months；
- Fertile woman must perform a pregnancy test (serum or urine) 7 days before screened, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib. For man, surgical sterilization should be performed, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib；
Key exclusion criteria (17 listed)
- Blend cancer type with NSCLC or else；
- Brain MRI, CT or venography confirmed that there are brain hemorrhage symptoms;
- MRI, CT or venography confirmed that tumor invaded big vessels;
- Patients with uncontrollable hypertension (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg, despite optimal drug therapy).；
- Patients with with grade Ⅱ myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male ≥ 450 ms, female ≥470 ms)；
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 |
|---|---|---|
| ApatinibApatinib Mmesylate tablets 250mg/d, po, there's totally 4-6 cycles(21days per cycle) | Drug | experimental group |
| IrinotecanIrinotecan 80mg/m2 d1, d8, vi, there's totally 4-6 cycles(21days per cycle) | Drug | controlled group, experimental group |
Primary outcome
duration of treatment
Time frame: two years
time from take apatinib to withdrawal from experiment due to adverse reaction of apatinib
1 secondary outcome
progress free survival and overall survival
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apatinib and Irinotecan in people with Small Cell Lung Cancer, run by Beijing Chest Hospital.
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 7 inclusion and 17 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 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Hui Zhang, Vice Director (010-89509281, bjchzhanghui@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of treatment (time frame: two years). 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 29 Aug 2018.