Lung CancerPhase 3NCT02283476
The Comparative Study on Rh-Endostatin (Endostar®) Continuous Intravenous Infusion and Routine i.v in Combination With GP Regimens for Phase III B/IV Squamous Cell Lung Cancer and Biological Markers Exploration.
A Phase 3 study testing Endostar continuous intravenous infusion, Endostar routine intravenous infusion and Gemcitabine in people with Lung Cancer, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
Endostar is a anti-angiogenesis product and has been launched in China . The efficacy and safety have been defined. However, the compliance is unsatisfactory since routine i.v of Endostar is needed for 3 to 4 hours daily during one cycle of 14 days. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Endostar continuous intravenous infusion, Endostar routine intravenous infusion and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Nov 2017
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary lung squamous carcinoma confirmed by cytology and histology, excluding sputum examination.
- phase IIIB /IV based on IASLC 2009 TNM criteria.
- at least one measurable tumor based on RECIST 1.1 ( longest diameter: ≥20 mm by CT scan or 10 mm by spiral CT )
- male or female, age≥18 or ≤75 years old
- ECOG PS: 0 or 1
- estimated time of survival: ≥ 3 months
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- suitable hematologic function: ANC≥2×109/L, PLC≥100×109/L and Hb≥9 g/dL
- suitable liver function: Total bilirubin≤normal ULN, AST and ALT≤2.5×normal ULN, ALP≤5×normal ULN.
- suitable renal function: Cr≤normal ULN,or Ccr≥60 ml/min
- EKG normal
- without no healing wound
- no history of anti-cancer therapy, or adjuvant/neo-adjuvant chemotherapy for non-metastatic tumor finished for more than 6 months before enrolment.
- for the female subject with productive ability, urine pregnancy test must be done and is negative within 7 days before enrolment.
- no history of serious allergic to biologic agents, especially E.Coli products
- the authorized ICF must be signed
Who cannot join
- Woman in pregnancy and breast-feeding, or having productive ability without contraception.
- Having the serious acute infection uncontrolled or purulent/chronic infection with unhealed wound.
- Having the serious heart disease, including congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, valvular disease, and refractory hypertension.
- Having uncontrolled nervous or mental disease with low compliance and reluctance to description of response; uncontrolled primary brain tumor or other metastatic brain cancer with obvious intracranial hypertension or mental symptoms.
- Having the tendency of bleeding, such as FIB<2G/L
- Being receiving adjuvant chemotherapy.
- On other conditions investigator considers, the subject is not fitful to participate the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Cancer Hospital
Tianjin, 300060
Jinhuai Xue, Master, 8613502065304, xuejh1210@sina.com
Kai Li, Doctor
About this study
Endostar is a anti-angiogenesis product and has been launched in China . The efficacy and safety have been defined. However, the compliance is unsatisfactory since routine i.v of Endostar is needed for 3 to 4 hours daily during one cycle of 14 days. The continuous intravenous infusion by using venous pump can improve the compliance.The comparative study in efficacy and safety has not been done concerning continuous and routine i.v.In addition, what patient can be benefited from Endostar have not been investigated. The biological markers, such as circulating endothelial cells，CECs, will be explored in the study.
- Conditions
- Lung Cancer
- Being tested
- Endostar continuous intravenous infusion, Endostar routine intravenous infusion, Gemcitabine, Cisplatin
- Keywords
- efficacy and safety
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endostar continuous intravenous infusionDrug
Endostar,7.5mg/m2, continuous intravenous infusion for 14 days each cycle, 21 days as one cycle, 4 cycles in total.
Endostar routine intravenous infusionDrug
Endostar,7.5mg/m2, routine intravenous infusion 3-4 hours daily each cycle,21 days as one cycle, 4 cycles in total
GemcitabineDrug
Gemcitabine,1000-1250mg/m2,i.v d1,d8 in each cycle,21 days as one cycle, 4 cycles in total
CisplatinDrug
Cisplatin,75mg/m2,i.v d1 or d1-3 in each cycle,21 days as one cycle, 4 cycles in total
| Study group | Role | What they receive |
|---|---|---|
| Endostar continuous intravenous infusion | Experimental | Endostar continuous intravenous infusion in combination with Gemcitabine and Cisplatin Receives: Drug: Endostar continuous intravenous infusion; Drug: Gemcitabine; Drug: Cisplatin |
| Endostar routine intravenous infusion | Active comparator | Endostar routine intravenous infusion in combination with Gemcitabine and Cisplatin Receives: Drug: Endostar routine intravenous infusion; Drug: Gemcitabine; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate based on Recist 1.1 edition
Measured: 3 months
progress free survival
Measured: 18 months
Secondary outcomes (2)
overall survival
Measured: 24 months
Quality of life (QoL) Questionnaire
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 posted5 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu Simcere Pharmaceutical Co., Ltd.The 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
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02283476
- Sponsor's protocol ID
- SIM-ED-1302
- Status last verified
- Oct 2014
- First submitted
- 3 Nov 2014
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Study on Rh-Endostatin (Endostar®) Continuous Intravenous Infusion and Routine i.v in Combination With GP Regimens for Phase III B/IV Squamous Cell Lung Cancer and Biological Markers Exploration.
- ClinicalTrials.gov ID
- NCT02283476
- Acronym / sponsor ID
- SIM-ED-1302
- Conditions
- Lung Cancer
- Keywords
- efficacy and safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 5 Nov 2014 (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.
Endostar is a anti-angiogenesis product and has been launched in China . The efficacy and safety have been defined. However, the compliance is unsatisfactory since routine i.v of Endostar is needed for 3 to 4 hours daily during one cycle of 14 days. The continuous intravenous infusion by using venous pump can improve the compliance.The comparative study in efficacy and safety has not been done concerning continuous and routine i.v.In addition, what patient can be benefited from Endostar have not been investigated. The biological markers, such as circulating endothelial cells，CECs, will be explored in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endostar continuous intravenous infusion | Experimental | Drug: Endostar continuous intravenous infusion, Drug: Gemcitabine, Drug: CisplatinEndostar continuous intravenous infusion in combination with Gemcitabine and Cisplatin |
| Endostar routine intravenous infusion | Active comparator | Drug: Endostar routine intravenous infusion, Drug: Gemcitabine, Drug: CisplatinEndostar routine intravenous infusion in combination with Gemcitabine and Cisplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- primary lung squamous carcinoma confirmed by cytology and histology, excluding sputum examination.
- phase IIIB /IV based on IASLC 2009 TNM criteria.
- at least one measurable tumor based on RECIST 1.1 ( longest diameter: ≥20 mm by CT scan or 10 mm by spiral CT )
- male or female, age≥18 or ≤75 years old
- ECOG PS: 0 or 1
Key exclusion criteria (7 listed)
- Woman in pregnancy and breast-feeding, or having productive ability without contraception.
- Having the serious acute infection uncontrolled or purulent/chronic infection with unhealed wound.
- Having the serious heart disease, including congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, valvular disease, and refractory hypertension.
- Having uncontrolled nervous or mental disease with low compliance and reluctance to description of response; uncontrolled primary brain tumor or other metastatic brain cancer with obvious intracranial hypertension or mental symptoms.
- Having the tendency of bleeding, such as FIB<2G/L
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 |
|---|---|---|
| Endostar continuous intravenous infusionEndostar,7.5mg/m2, continuous intravenous infusion for 14 days each cycle, 21 days as one cycle, 4 cycles in total. | Drug | Endostar continuous intravenous infusion |
| Endostar routine intravenous infusionEndostar,7.5mg/m2, routine intravenous infusion 3-4 hours daily each cycle,21 days as one cycle, 4 cycles in total | Drug | Endostar routine intravenous infusion |
| GemcitabineGemcitabine,1000-1250mg/m2,i.v d1,d8 in each cycle,21 days as one cycle, 4 cycles in total | Drug | Endostar continuous intravenous infusion, Endostar routine intravenous infusion |
| CisplatinCisplatin,75mg/m2,i.v d1 or d1-3 in each cycle,21 days as one cycle, 4 cycles in total | Drug | Endostar continuous intravenous infusion, Endostar routine intravenous infusion |
Primary outcome
objective response rate based on Recist 1.1 edition
Time frame: 3 months
progress free survival
Time frame: 18 months
2 secondary outcomes
overall survival
Time frame: 24 months
Quality of life (QoL) Questionnaire
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 6 Nov 2014.
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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.
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 Endostar continuous intravenous infusion, Endostar routine intravenous infusion and Gemcitabine in people with Lung Cancer, run by Jiangsu Simcere Pharmaceutical Co., Ltd. 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 15 inclusion and 7 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 6 Nov 2014. 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 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 Zhao Yan, Doctor (18622221369, yanzhao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate based on Recist 1.1 edition (time frame: 3 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?
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 6 Nov 2014.