NSCLCPhase 3NCT01560195
A Study of Pegylated rhG-CSF as Support to Advanced Non-Small-Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy Receiving Chemotherapy
A Phase 3 study testing Pegylated rhG-CSF: 100µg/kg and Pegylated rhG-CSF: 6mg in people with NSCLC and Neutropenia, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- NSCLC, Neutropenia, Febrile Neutropenia
- What is being tested?
- Pegylated rhG-CSF: 100µg/kg and Pegylated rhG-CSF: 6mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Apr 2012to Jan 2013
- 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
- Investigator diagnosis of staged III or IV NSCLC
- Age 18 to 70 years
- ECOG performance status ≤ 1
- Chemotherapy naïve
- Body weight ≥ 45kg
- Hemoglobin ≥ 100g/L; white blood cell ≥ 4.0×109/L; absolute neutrophil count ≥1.5 × 109/L; platelet count ≥ 100 × 109/L
- Alanine transarninase ≤1.5×ULN; aspartate aminotransferase ≤1.5×ULN; serum creatinine ≤1.5×ULN; total bilirubin ≤1.5×ULN
Who cannot join
- History of systematic chemotherapy or radical radiation therapy
- Prior bone marrow or stem cell transplantation
- Received systemic antibiotics treatment within 72 h of chemotherapy
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Caicun Zhou, M. D., caicunzhou@yahoo.com.cn
About this study
Official title: A Double-Blind, Placebo-Controlled, Multicenter, Randomized Study Evaluating the Prophylactic Use of Pegylated Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) on the Incidence of Neutropenia in Subjects With Advanced Non-Small-Cell Lung Cancer (NSCLC) Treated With Myelosuppressive Chemotherapy
Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with filgrastim. The purpose of this study is to determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following chemotherapy in patients with advanced NSCLC.
- Conditions
- NSCLC, Neutropenia, Febrile Neutropenia
- Being tested
- Pegylated rhG-CSF: 100µg/kg, Pegylated rhG-CSF: 6mg, placebo and rhG-CSF 5ug/kg/d
- Keywords
- neutropenia, febrile neutropenia, chemotherapy
- Medical subject headings
- Neutropenia, Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated rhG-CSF: 100µg/kgDrug
Patients were administered pegylated rhG-CSF 100 ug/kg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: docetaxel 75 mg/m2; carboplatin area under curve[AUC] 5 or cisplatin 75 mg/m2.
Pegylated rhG-CSF: 6mgDrug
Patients were administered pegylated rhG-CSF 6mg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: docetaxel 75 mg/m2; carboplatin area under curve[AUC] 5 or cisplatin 75 mg/m2.
placebo and rhG-CSF 5ug/kg/dDrug
Patients receiving chemotherapy and placebo in cycle 1 and rhG-CSF 5ug/kg/d in cycle 2 to 4. Chemotherapy regimen: docetaxel 75 mg/m2; carboplatin area under curve[AUC] 5 or cisplatin 75 mg/m2.
| Study group | Role | What they receive |
|---|---|---|
| Pegylated rhG-CSF: 100µg/kg | Experimental | Staged III or IV NSCLC patients receiving chemotherapy and Pegylated rhG-CSF 100µg/kg Receives: Drug: Pegylated rhG-CSF: 100µg/kg |
| Pegylated rhG-CSF: 6mg | Experimental | Staged III or IV NSCLC patients receiving chemotherapy and pegylated rhG-CSF 6mg Receives: Drug: Pegylated rhG-CSF: 6mg |
| Placebo | Placebo comparator | Staged III or IV NSCLC patients receiving chemotherapy and placebo in cycle 1 and rhG-CSF in cycle 2 to 4 Receives: Drug: placebo and rhG-CSF 5ug/kg/d |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of grade 3/4 neutropenia in cycle 1
the rate of ANC lower than 1.0 × 109/L
Measured: 21 days
Secondary outcomes (8)
Incidence of febrile neutropenia in cycle 1
rate of ANC<1.0×109/L and auxiliary temperature>38.5℃
Measured: 21 days
Rate of grade 3/4 neutropenia and incidence of febrile neutropenia in cycle 2 to 4
The rate of ANC lower than 1.0 × 109 /L and rate of ANC<1.0×109/L and auxiliary temperature>38.5℃
Measured: Through 2 to 4 cycles
Time to neutrophil recovery in the 4 chemotherapy cycles
After chemotherapy administration the time from the expected nadir until the patient's ANC increased to 2.0 × 109/L
Measured: Through 4 cycles
Duration of 3/4 neutropenia in the 4 chemotherapy cycles
duration of ANC lower than 1.0 × 109/L
Measured: Through 4 cycles
Objective response rate
Measured: Through 4 cycles
Progress free survival
Measured: Through 4 cycles
Overall survival
Measured: Through 4 cycles
Exploratory biomarkers research
Relationship between SNP and microRNA with myelosuppression and tumor response rate
Measured: Through 4 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Caicun Zhou, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560195
- Sponsor's protocol ID
- HHPG-19K -III-02
- Status last verified
- Nov 2012
- First submitted
- 8 Mar 2012
- Last updated
- 6 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Multicenter, Randomized Study Evaluating the Prophylactic Use of Pegylated Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) on the Incidence of Neutropenia in Subjects With Advanced Non-Small-Cell Lung Cancer (NSCLC) Treated With Myelosuppressive Chemotherapy
- ClinicalTrials.gov ID
- NCT01560195
- Acronym / sponsor ID
- HHPG-19K -III-02
- Conditions
- NSCLC, Neutropenia, Febrile Neutropenia
- Keywords
- neutropenia, febrile neutropenia, chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jan 2013 (estimated)
- First posted
- 22 Mar 2012 (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.
Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with filgrastim. The purpose of this study is to determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following chemotherapy in patients with advanced NSCLC.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pegylated rhG-CSF: 100µg/kg | Experimental | Drug: Pegylated rhG-CSF: 100µg/kgStaged III or IV NSCLC patients receiving chemotherapy and Pegylated rhG-CSF 100µg/kg |
| Pegylated rhG-CSF: 6mg | Experimental | Drug: Pegylated rhG-CSF: 6mgStaged III or IV NSCLC patients receiving chemotherapy and pegylated rhG-CSF 6mg |
| Placebo | Placebo comparator | Drug: placebo and rhG-CSF 5ug/kg/dStaged III or IV NSCLC patients receiving chemotherapy and placebo in cycle 1 and rhG-CSF in cycle 2 to 4 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Investigator diagnosis of staged III or IV NSCLC
- Age 18 to 70 years
- ECOG performance status ≤ 1
- Chemotherapy naïve
- Body weight ≥ 45kg
Key exclusion criteria (4 listed)
- History of systematic chemotherapy or radical radiation therapy
- Prior bone marrow or stem cell transplantation
- Received systemic antibiotics treatment within 72 h of chemotherapy
- Pregnancy or lactation
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 |
|---|---|---|
| Pegylated rhG-CSF: 100µg/kgPatients were administered pegylated rhG-CSF 100 ug/kg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: docetaxel 75 mg/m2; carboplatin area under curve[AUC] 5 or cisplatin 75 mg/m2. | Drug | Pegylated rhG-CSF: 100µg/kg |
| Pegylated rhG-CSF: 6mgPatients were administered pegylated rhG-CSF 6mg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: docetaxel 75 mg/m2; carboplatin area under curve[AUC] 5 or cisplatin 75 mg/m2. | Drug | Pegylated rhG-CSF: 6mg |
| placebo and rhG-CSF 5ug/kg/dPatients receiving chemotherapy and placebo in cycle 1 and rhG-CSF 5ug/kg/d in cycle 2 to 4. Chemotherapy regimen: docetaxel 75 mg/m2; carboplatin area under curve[AUC] 5 or cisplatin 75 mg/m2. | Drug | Placebo |
Primary outcome
Rate of grade 3/4 neutropenia in cycle 1
Time frame: 21 days
the rate of ANC lower than 1.0 × 109/L
8 secondary outcomes
Incidence of febrile neutropenia in cycle 1
Time frame: 21 days
Rate of grade 3/4 neutropenia and incidence of febrile neutropenia in cycle 2 to 4
Time frame: Through 2 to 4 cycles
Time to neutrophil recovery in the 4 chemotherapy cycles
Time frame: Through 4 cycles
Duration of 3/4 neutropenia in the 4 chemotherapy cycles
Time frame: Through 4 cycles
Objective response rate
Time frame: Through 4 cycles
Progress free survival
Time frame: Through 4 cycles
Overall survival
Time frame: Through 4 cycles
Exploratory biomarkers research
Time frame: Through 4 cycles
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2012.
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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.
Caicun Zhou principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
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 Pegylated rhG-CSF: 100µg/kg and Pegylated rhG-CSF: 6mg in people with NSCLC and Neutropenia, run by Jiangsu HengRui Medicine 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 7 inclusion and 4 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 2012. 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?
Contact Caicun Zhou, M. D. (862165115006 ext. 1053, caicunzhou@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of grade 3/4 neutropenia in cycle 1 (time frame: 21 days). 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 2012.