Non-small Cell Lung CancerPhase 3NCT01287962
Apatinib in the Treatment of Advanced Non-squamous Non-small Cell Lung Cancer
A Phase 3 study testing apatinib in people with Non-small Cell Lung Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
Apatinib is a new kind of Vascular endothelial growth factor receptor(VEGFR) tyrosine kinase inhibitors (TKIs). The investigators have finished the preclinical and phase I and phase II clinical study for apatinib and found its satisfactory anti-tumor activity and tolerated toxicities. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- apatinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- Apr 2011to Mar 2014
- 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
- Patients 18 to 70 years of age
- Documented pathological evidence of advanced non-squamous non-small cell lung cancer with measurable lesions
- Failure of epidermal-growth-factor receptor (EGFR) TKIs target treatment and second-line or more regimens of chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 1
- Patients had to have recovered from any toxic effects of therapy
- Patients with brain/meninges metastasis should keep stable disease for 2 months before randomisation
- Adequate hematologic and biochemical values were required
Who cannot join
- Presence of small-cell lung cancer alone or with NSCLC
- Pregnant or breast-feeding women
- Severe or uncontrolled systemic disease such as clinically significant hypertension(systolic pressure > 140 mmHg，diastolic pressure > 90 mmHg), cardiac ischemia and infarction, ventricular arrhythmias(QT ≥ 440ms) and grade 1 cardiac insufficiency
- Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction)
- Coagulation disfunction,hemorrhagic tendency or receiving anticoagulant therapy
- ≥ CTCAE 2 pneumorrhagia or ≥ CTCAE 3 hemorrhage in other organs within 4 weeks
Show all 12Show fewer
- Bone fracture or wounds that was not cured for a long time
- Arterial thrombus or phlebothrombosis within 6 months and taking anticoagulant agents
- Mental diseases and psychotropic substances abuse
- Previous treatment with an experimental agent within 4 weeks
- Previous treatment with VEGFR、platelet derived growth factor receptor(PDGFR) TKIS
- Other coexisting malignant disease (apart from basal-cell carcinoma and carcinoma in situ of uterine cervix)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Apatinib in the Treatment of Advanced Non-squamous Non-small Cell Lung Cancer:a Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study
Apatinib is a new kind of Vascular endothelial growth factor receptor(VEGFR) tyrosine kinase inhibitors (TKIs). The investigators have finished the preclinical and phase I and phase II clinical study for apatinib and found its satisfactory anti-tumor activity and tolerated toxicities. A disease-control rate of 75% was found in lung cancer patients. In the present phase III trial, the investigators will further evaluate the efficacy and toxicities of apatinib in the treatment of advanced non-squamous non-small cell lung cancer.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- apatinib, placebo
- Keywords
- Apatinib, Non-small Cell Lung Cancer, VEGFR TKIs
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apatinibDrug
750 mg，po，QD； 28 days every cycle
placeboDrug
po，QD； 28 days every cycle
| Study group | Role | What they receive |
|---|---|---|
| Apatinib | Experimental | 750 mg，po，QD； 28 days every cycle Receives: Drug: apatinib |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Progression-free survival as the time from randomization to documented disease progression according to response evaluation criteria in solid tumors (RECIST) or death.
Measured: 24 months
Secondary outcomes (3)
Objective Response Rate(ORR)
ORR was the percentage of patients who got partial or complete response
Measured: 24 months
Overall Survival(OS)
OS was determined from date of enrollment until death or the date the patient was recorded alive of last follow-up
Measured: 24 months
Toxicity
Adverse events (AEs) were recorded, graded for toxicity using the NCI-CTC, and assessed by the investigator for any relationship with treatment.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2013
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zhang, Sun Yat-sen University
- Investigators
- Li Zhang, MD, Study chair, Cancer Center of Sun Yat-Sen University (CCSU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287962
- Sponsor's protocol ID
- HENGRUI 20110301
- Status last verified
- Jan 2012
- First submitted
- 31 Jan 2011
- Last updated
- 9 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apatinib in the Treatment of Advanced Non-squamous Non-small Cell Lung Cancer:a Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study
- ClinicalTrials.gov ID
- NCT01287962
- Acronym / sponsor ID
- HENGRUI 20110301
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Apatinib, Non-small Cell Lung Cancer, VEGFR TKIs
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Mar 2014 (estimated)
- First posted
- 2 Feb 2011 (estimated)
- 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.
Apatinib is a new kind of Vascular endothelial growth factor receptor(VEGFR) tyrosine kinase inhibitors (TKIs). The investigators have finished the preclinical and phase I and phase II clinical study for apatinib and found its satisfactory anti-tumor activity and tolerated toxicities. A disease-control rate of 75% was found in lung cancer patients. In the present phase III trial, the investigators will further evaluate the efficacy and toxicities of apatinib in the treatment of advanced non-squamous non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apatinib | Experimental | Drug: apatinib750 mg，po，QD； 28 days every cycle |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients 18 to 70 years of age
- Documented pathological evidence of advanced non-squamous non-small cell lung cancer with measurable lesions
- Failure of epidermal-growth-factor receptor (EGFR) TKIs target treatment and second-line or more regimens of chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 1
- Patients had to have recovered from any toxic effects of therapy
Key exclusion criteria (12 listed)
- Presence of small-cell lung cancer alone or with NSCLC
- Pregnant or breast-feeding women
- Severe or uncontrolled systemic disease such as clinically significant hypertension(systolic pressure > 140 mmHg，diastolic pressure > 90 mmHg), cardiac ischemia and infarction, ventricular arrhythmias(QT ≥ 440ms) and grade 1 cardiac insufficiency
- Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction)
- Coagulation disfunction,hemorrhagic tendency or receiving anticoagulant therapy
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 |
|---|---|---|
| apatinib750 mg，po，QD； 28 days every cycle | Drug | Apatinib |
| placebopo，QD； 28 days every cycle | Drug | Placebo |
Primary outcome
Progression free survival (PFS)
Time frame: 24 months
Progression-free survival as the time from randomization to documented disease progression according to response evaluation criteria in solid tumors (RECIST) or death.
3 secondary outcomes
Objective Response Rate(ORR)
Time frame: 24 months
Overall Survival(OS)
Time frame: 24 months
Toxicity
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2013.
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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.
Li Zhang, MD study chair
Cancer Center of Sun Yat-Sen University (CCSU)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing apatinib in people with Non-small Cell Lung Cancer, run by Sun Yat-sen University 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 7 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 9 Dec 2013. 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. Some participants in this study may receive a placebo. 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?
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?
Progression free survival (PFS) (time frame: 24 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 9 Dec 2013.