Advanced Lung Squamous CarcinomaPhase 4NCT02513342
Endostar First-line Treatment of Advanced Non-small Cell Lung Squamous Carcinoma
A Phase 4 study testing Endostar, Docetaxel and Cisplatin in people with Advanced Lung Squamous Carcinoma, run by Nanjing NingQi Medicine Science and Technology Co., Ltd. at 2 sites in China.
Trial summary
Explore the efficacy and safety of the treatment of Endostar continuous intravenous injection pump combined DP scheme for first-line advanced lung squamous carcinoma and maintenance treatment., and explore the predicted biomarkers. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Lung Squamous Carcinoma
- What is being tested?
- Endostar, Docetaxel and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesChina
- Study dates
- Mar 2015to Apr 2018
- Phase
- Phase 4
- 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
- Cytological and histological confirmation（Do not accept single sputum cytology in the diagnosis of patients） in patients diagnosed of lung squamous carcinoma;
- According to a new IASLC2009 lung cancer TNM stages judged stage IIIB or IV non-small cell lung cancer.
- Must have at least one evaluated lesion,according to the RRECIST version 1.1 standard (the longest diameter on spiral CT at least 10 mm,the longest diameter on plain CT at least 20 mm);
- Male or female, age between 18 and 75 years old ;
- ECOG PS 0~1；
- Expected survival period ≥ 3 months or more
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- Enough blood function: absolute neutrophil count (ANC)≥2 x 109 / L and the platelet count≥ 100 x 109 / L and hemoglobin ≥9 g/dL;
- Enough liver function: total bilirubin acuities≤the upper limit of normal (ULN); AST and ALT acuities ≤2.5 times of the upper limit of normal (ULN); Alkaline phosphatase ≤5 times of the upper limit of normal(ULN);
- Enough renal function：serum creatinine ≤the limit of normal(ULN) or calculated creatinine clearance≥60 mL/min.
- The electrocardiogram (ecg) basicaly normal,the body had no to heal wounds
- No previous anti-tumor drug therapy, or only received for non metastatic tumor of adjuvant or neoadjuvant chemotherapy, but has ended more than six months before the study start.
- Patients had surgery before,but have more than 4 weeks before the study star, and the patient has recovered;
- Women with cmpleted uterus before intact in the group within 28 days must have a negative pregnancy test results (unles amenorrhea for 24 months). If the pregnancy test from the first time for more than 7 days,the patients need for urine pregnancy test(within 7 days before the first delivery).
- Prior to biological agents, especially e. coli genetically engineered products without severe allergic reactions;
- Sign the informed consent.
Who cannot join
- Pregnancy, nursing mothers, or female patients with fertility but no contraception.
- Existing serious acute infection, and can not be controlled; Or with fester sex and chronic infection,or wound in delay;
- Original serious heart disease, including: congestive heart failure, uncontroled high risk arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension;
- With uncontroled nerve, mental illness or mental disorders, compliance is poor, can't cooperate and response to treatment; Uncontroled primary brain tumors or CNS metastases illness, with obvious symptoms in cranial hypertension or nerve spirit;
- With a bleeding tendency
- Researchers believe that patients should not participate in this test.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Jinling Hospital
Nanjing, Jiangsu, 210002
Yin Qingfeng, Manager, 0086013912903257, y_qingfeng@163.com
Zhou Xiaolei, Manager, 0086013776639377, zhouxiaolei@simcere.com
- Recruiting
The first affiliated hospital of soochow university
Suzhou, Jiangsu, 215006
Yin Qingfeng, mananger, 08613912903257, y_qingfeng@163.com
Zhou Xiaolei, mananger, 08613776639377, zhouxiaolei@simcere.com
About this study
Official title: Endostar First-line Treatment of Advanced Non-small Cell Lung Squamous Carcinoma Based on Chemotherapy for Advanced Non-small Cell Lung Squamous Carcinoma Patients：a Randomized Controlled,Open, Multicenter Clinical Study
Explore the efficacy and safety of the treatment of Endostar continuous intravenous injection pump combined DP scheme for first-line advanced lung squamous carcinoma and maintenance treatment., and explore the predicted biomarkers.
- Conditions
- Advanced Lung Squamous Carcinoma
- Keywords
- Endostar,Advanced lung squamous carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndostarBiological
Endostar 30mg continuous intravenous injection pump,d1-d7；
DocetaxelDrug
d4 Docetaxel，75（mg/m2），iv；
CisplatinDrug
d4，cisplatin，75（mg/m2），iv；
| Study group | Role | What they receive |
|---|---|---|
| Endostar+Docetaxel+Cisplatin | Experimental | Patients in this group will be given conventional chemotherapy medicine: Docetaxel+Cisplatin chemotherapy recommended by treatment guidelines for Advanced Non-small Cell Lung Squamous Carcinoma , and the Endostar-Recombinant human endostatin injection is injected by 30mg continuous intravenous injection pump,d1-d7. Receives: Biological: Endostar; Drug: Docetaxel; Drug: Cisplatin |
| Docetaxel+Cisplatin | Active comparator | Patients in this group will be given conventional chemotherapy medicine: Docetaxel+Cisplatin chemotherapy recommended by treatment guidelines for Advanced Non-small Cell Lung Squamous Carcinoma. Receives: Drug: Docetaxel; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
FS is a tumor progression or death time of a patient who has an objective record on the date of enrollment. PFS calculation end if the patient was lost, unknow death , or other anti tumor therapy was used.
Measured: up to month 36
Secondary outcomes (3)
overall remission rate(ORR)
Measured: change from Baseline at the week 6, 12 of the treatment phase, the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase.
Disease control rate （DCR）
Measured: change from Baseline at the week 6, 12 of the treatment phase, the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase.
Overall survival（OS）
Measured: change from Baseline at the week 6, 12 of the treatment phase, the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2017 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Lung Squamous CarcinomaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing NingQi Medicine Science and Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513342
- Sponsor's protocol ID
- JSLCG-001
- Status last verified
- Mar 2015
- First submitted
- 17 Jul 2015
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endostar First-line Treatment of Advanced Non-small Cell Lung Squamous Carcinoma Based on Chemotherapy for Advanced Non-small Cell Lung Squamous Carcinoma Patients：a Randomized Controlled,Open, Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT02513342
- Acronym / sponsor ID
- JSLCG-001
- Conditions
- Advanced Lung Squamous Carcinoma
- Keywords
- Endostar,Advanced lung squamous carcinoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Nanjing NingQi Medicine Science and Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 31 Jul 2015 (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.
Explore the efficacy and safety of the treatment of Endostar continuous intravenous injection pump combined DP scheme for first-line advanced lung squamous carcinoma and maintenance treatment., and explore the predicted biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endostar+Docetaxel+Cisplatin | Experimental | Biological: Endostar, Drug: Docetaxel, Drug: CisplatinPatients in this group will be given conventional chemotherapy medicine: Docetaxel+Cisplatin chemotherapy recommended by treatment guidelines for Advanced Non-small Cell Lung Squamous Carcinoma , and the Endostar-Recombinant human endostatin injection is injected by 30mg continuous intravenous injection pump,d1-d7. |
| Docetaxel+Cisplatin | Active comparator | Drug: Docetaxel, Drug: CisplatinPatients in this group will be given conventional chemotherapy medicine: Docetaxel+Cisplatin chemotherapy recommended by treatment guidelines for Advanced Non-small Cell Lung Squamous Carcinoma. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Cytological and histological confirmation（Do not accept single sputum cytology in the diagnosis of patients） in patients diagnosed of lung squamous carcinoma;
- According to a new IASLC2009 lung cancer TNM stages judged stage IIIB or IV non-small cell lung cancer.
- Must have at least one evaluated lesion,according to the RRECIST version 1.1 standard (the longest diameter on spiral CT at least 10 mm,the longest diameter on plain CT at least 20 mm);
- Male or female, age between 18 and 75 years old ;
- ECOG PS 0~1；
Key exclusion criteria (6 listed)
- Pregnancy, nursing mothers, or female patients with fertility but no contraception.
- Existing serious acute infection, and can not be controlled; Or with fester sex and chronic infection,or wound in delay;
- Original serious heart disease, including: congestive heart failure, uncontroled high risk arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension;
- With uncontroled nerve, mental illness or mental disorders, compliance is poor, can't cooperate and response to treatment; Uncontroled primary brain tumors or CNS metastases illness, with obvious symptoms in cranial hypertension or nerve spirit;
- With a bleeding tendency
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 |
|---|---|---|
| EndostarEndostar 30mg continuous intravenous injection pump,d1-d7； | Biological | Endostar+Docetaxel+Cisplatin |
| Docetaxeld4 Docetaxel，75（mg/m2），iv； | Drug | Docetaxel+Cisplatin, Endostar+Docetaxel+Cisplatin |
| Cisplatind4，cisplatin，75（mg/m2），iv； | Drug | Docetaxel+Cisplatin, Endostar+Docetaxel+Cisplatin |
Primary outcome
Progression-free Survival (PFS)
Time frame: up to month 36
FS is a tumor progression or death time of a patient who has an objective record on the date of enrollment. PFS calculation end if the patient was lost, unknow death , or other anti tumor therapy was used.
3 secondary outcomes
overall remission rate(ORR)
Time frame: change from Baseline at the week 6, 12 of the treatment phase, the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase.
Disease control rate （DCR）
Time frame: change from Baseline at the week 6, 12 of the treatment phase, the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase.
Overall survival（OS）
Time frame: change from Baseline at the week 6, 12 of the treatment phase, the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Endostar, Docetaxel and Cisplatin in people with Advanced Lung Squamous Carcinoma, run by Nanjing NingQi Medicine Science and Technology Co., Ltd. at 2 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 15 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: status not confirmed, as of the sponsor's last update on 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Yin Qingfeng, manager (0086-02585632992, y_qingfeng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: up to month 36). 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 31 Jul 2015.