Non-small Cell Lung CancerPhase 3NCT03262948
Nab-Paclitaxel Versus Paclitaxel Plus Carboplatin in Advanced Squamous Cell Non Small Cell Lung Cancer
A Phase 3 study testing nab-paclitaxel, Paclitaxel and Carboplatin in people with Non-small Cell Lung Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Trial summary
This is a randomized, multicenter, open, controlled phase III trial. 388 subjects with stage IIIB who were not eligible for radical surgery or radiotherapy, stage IV or recurrent squamous cell NSCLC were enrolled in this study .The subjects will be randomly assigned to one of the two treatment groups at a 1: 1 ratio… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- nab-paclitaxel, Paclitaxel and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2017to 1 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Accepted the purpose of the trial, the contents , the predicted efficacy, pharmacological effects and the full explanation of the risk and was understood that the subject had signed the informed consent.
- Subjects had histopathologically or cytologically confirmed NSCLC type of squamous cell carcinoma and were documented; (must be provided without radiotherapy, fixed with formalin, paraffin At least 5 sheets of tumor tissue after embedding)
- Subjects were IIIB who were not suitable for radical surgery or radiotherapy, IV or recurrent NSCLC ; (according to the 7th edition of the International Lung Cancer Research Council (IASLC) classification)
- Subjects who were palliative radiotherapy for bone lesions other than the chest were given the study drug according to CTCAE 4.03 toxicity ≤1
- at least one measurable objective lesions according to RECIST1.1 standard
- ECOG score ≤ 1
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- Expected survival time ≥ 3 months
- Subjects are well-behaved, able to undergo treatment and follow-up, and voluntarily comply with this study
- ≥ 18 years old male and female
- The childbearing age subjects must agree to take effective contraceptive measures during the trial; the serum or urine pregnancy test must be negative before 24 hours of the start of chemotherapy
- Women must be non-lactating
Who cannot join
- There is brain metastases;
- The investigators believe that uncontrolled serious medical illnesses that affect the ability of subjects to receive research programs, such as severe medical illnesses, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled high blood pressure, Uncontrolled infections, active peptic ulcers;
- Will hinder the understanding or make informed consent or fill in the questionnaire of dementia, mental state changes or any mental illness;
- Any history of allergic or hypersensitivity to any treatment ingredient;
- In the first 5 years of randomization, there were malignant tumors other than NSCLC, except for the treatment of basal cells or squamous cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ
- Previously received treatment for advanced/metastatic NSCLC. Note: Allow chemotherapy and radiotherapy to be used as part of neoadjuvant/adjuvant therapy as long as the treatment has ended at least 12 months before the diagnosis of advanced or metastatic disease.
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- Received a taxane-based regimen as a neoadjuvant/adjuvant therapy for squamous cell carcinoma ;
- Subjects with ≥2 grade peripheral neuropathy according to CTCAE V 4.03;
- Physical examination and laboratory test results are abnormal ANC：<1.5×109 / L； PLT：<100×109/L； Hb: <90g/L
- Abnormal liver function is defined as:
- total bilirubin (TBil) level:> normal upper limit (ULN) 1.5 times; II) 2.5 times the rate of aspartate aminotransferase (AST) and alanine aminotransferase (ALT)> ULN, and> 5 times ULN if liver metastases are present
- Definition of renal dysfunction:
- Serum creatinine> ULN 1.5 times, or creatinine clearance <50ml/min
- Coagulation function abnormal definition:
- International Standardization Ratio (INR)> 1.5 times the ULN, and prothrombin time (PT) or activated partial coagulation Blood enzyme time (aPTT)> ULN 1.5 times, unless the subject is receiving anticoagulant therapy
- Hepatitis B surface antigen positive (HBsAg), and peripheral blood hepatitis B virus DNA (HBV-DNA) titer ≥ 1×103copy number / L of the subjects; if HBsAg positive, and peripheral blood HBV-DNA <1 × 103 copy number / L, if the researchers believe that the subjects in a stable phase of chronic hepatitis B and does not increase the risk of subjects, the subjects eligible to be selected
- Hepatitis C virus (HCV) antibody positive or human immunodeficiency virus (HIV) antibody positive
- need to merge other anti-tumor drug treatment
- Received any other test drug treatment or participated in another interventional clinical trial before 30 days of screening period;
- Researchers think it is not suitable for enrolling.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Randomized,Open, Multicenter Phase III Study to Compare the Effectiveness and Safety of Nab-Paclitaxel Versus Paclitaxel Plus Carboplatin First-Line Therapy Advanced Non Small Cell Lung Cancer Squamous Cell Carcinoma
This is a randomized, multicenter, open, controlled phase III trial. 388 subjects with stage IIIB who were not eligible for radical surgery or radiotherapy, stage IV or recurrent squamous cell NSCLC were enrolled in this study .The subjects will be randomly assigned to one of the two treatment groups at a 1: 1 ratio, and stratified by sex, ECOG physical status, smoking status, disease staging.
Read the detailed description
Subjects will receive one of two treatment regimens:
Group A: intravenous infusion of paclitaxel (albumin binding) 260 mg/m2, intravenous infusion, carboplatin area under curve （AUC) = 6, intravenous infusion, starting from randomization, once every 3 weeks, for 4-6 cycles,or progression, or intolerance, or deth or start a new anti-tumor treatment, whichever occurs first.
Group B: paclitaxel injection 175 mg/m2, intravenous infusion, carboplatin AUC= 6, intravenous infusion, starting from randomization, once every 3 weeks, for 4-6 cycles, or progression, or intolerance,or death or start a new anti-tumor treatment, whichever occurs first.The primary end point is overall response rate (ORR),the secondary endpoint is progression-free survival (PFS), overall survival (OS), safety and Quality of Life (QOL).
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- nab-paclitaxel, Paclitaxel, Carboplatin
- 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.
nab-paclitaxelDrug
Also called keaili
albumin-bound paclitaxel is 260 mg/m2 intravenously over 30 minutes on Days 1 of each 21-day cycle cycle immediately after albumin-bound paclitaxel
PaclitaxelDrug
Also called aosu
paclitaxel is 175 mg/m2 intravenously over 3 hours on Days 1 of each 21-day cycle cycle immediately after paclitaxel
CarboplatinDrug
Also called bobei
carboplatin is administered on Day 1 of each 21-day，followed by paclitaxel or nab-paclitaxel
| Study group | Role | What they receive |
|---|---|---|
| nab-paclitaxel plus carboplatin | Experimental | nab-paclitaxel 260mg/m2,i.v., plus carboplatin AUC = 6,i.v., starting from randomization, once every 3 weeks, for 4-6 cycles, or progression, or intolerance,or death or start a new anti-tumor treatment, whichever occurs first. Receives: Drug: nab-paclitaxel; Drug: Carboplatin |
| Paclitaxel plus carboplatin | Active comparator | paclitaxel 175 mg/m2,i.v., plus carboplatin AUC = 6,i.v., starting from randomization, once every 3 weeks, for 4-6 cycles, or progression, or intolerance,or death or start a new anti-tumor treatment, whichever occurs first. Receives: Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall respond rate
the rate of CR and PR
Measured: overall respond rate will be evaluated every 6 weeks until progression or new anti-cancer therapy initiation, up to 22 months.
Secondary outcomes (3)
PFS
progression free survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months
os
overall survival
Measured: From date of randomization until the date of death from any cause,assessed up to 18 months
Quality of life assessment
evaluate the QOL according to Functional Assessment of Cancer Therapy-lung (FACT-L)
Measured: It will be assessed before the administration of drugs at each first day of the chemotherapy cycle,up to 6 cycles,each cycle is 21 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start1 Dec 2017 (estimated)
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology 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
- 388 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- li zhang, doctor, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262948
- Sponsor's protocol ID
- NABP201706
- Status last verified
- Aug 2017
- First submitted
- 15 Aug 2017
- Last updated
- 13 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Socinski MA, Bondarenko I, Karaseva NA, Makhson AM, Vynnychenko I, Okamoto I, Hon JK, Hirsh V, Bhar P, Zhang H, Iglesias JL, Renschler MF. Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial. J Clin Oncol. 2012 Jun 10;30(17):2055-62. doi: 10.1200/JCO.2011.39.5848. Epub 2012 Apr 30.
PubMed 22547591
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Randomized,Open, Multicenter Phase III Study to Compare the Effectiveness and Safety of Nab-Paclitaxel Versus Paclitaxel Plus Carboplatin First-Line Therapy Advanced Non Small Cell Lung Cancer Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03262948
- Acronym / sponsor ID
- NABP201706
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 388 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 28 Aug 2017 (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.
This is a randomized, multicenter, open, controlled phase III trial. 388 subjects with stage IIIB who were not eligible for radical surgery or radiotherapy, stage IV or recurrent squamous cell NSCLC were enrolled in this study .The subjects will be randomly assigned to one of the two treatment groups at a 1: 1 ratio, and stratified by sex, ECOG physical status, smoking status, disease staging.
Detailed description
Subjects will receive one of two treatment regimens:
Group A: intravenous infusion of paclitaxel (albumin binding) 260 mg/m2, intravenous infusion, carboplatin area under curve （AUC) = 6, intravenous infusion, starting from randomization, once every 3 weeks, for 4-6 cycles,or progression, or intolerance, or deth or start a new anti-tumor treatment, whichever occurs first.
Group B: paclitaxel injection 175 mg/m2, intravenous infusion, carboplatin AUC= 6, intravenous infusion, starting from randomization, once every 3 weeks, for 4-6 cycles, or progression, or intolerance,or death or start a new anti-tumor treatment, whichever occurs first.The primary end point is overall response rate (ORR),the secondary endpoint is progression-free survival (PFS), overall survival (OS), safety and Quality of Life (QOL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nab-paclitaxel plus carboplatin | Experimental | Drug: nab-paclitaxel, Drug: Carboplatinnab-paclitaxel 260mg/m2,i.v., plus carboplatin AUC = 6,i.v., starting from randomization, once every 3 weeks, for 4-6 cycles, or progression, or intolerance,or death or start a new anti-tumor treatment, whichever occurs first. |
| Paclitaxel plus carboplatin | Active comparator | Drug: Paclitaxel, Drug: Carboplatinpaclitaxel 175 mg/m2,i.v., plus carboplatin AUC = 6,i.v., starting from randomization, once every 3 weeks, for 4-6 cycles, or progression, or intolerance,or death or start a new anti-tumor treatment, whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Accepted the purpose of the trial, the contents , the predicted efficacy, pharmacological effects and the full explanation of the risk and was understood that the subject had signed the informed consent.
- Subjects had histopathologically or cytologically confirmed NSCLC type of squamous cell carcinoma and were documented; (must be provided without radiotherapy, fixed with formalin, paraffin At least 5 sheets of tumor tissue after embedding)
- Subjects were IIIB who were not suitable for radical surgery or radiotherapy, IV or recurrent NSCLC ; (according to the 7th edition of the International Lung Cancer Research Council (IASLC) classification)
- Subjects who were palliative radiotherapy for bone lesions other than the chest were given the study drug according to CTCAE 4.03 toxicity ≤1
- at least one measurable objective lesions according to RECIST1.1 standard
Key exclusion criteria (20 listed)
- There is brain metastases;
- The investigators believe that uncontrolled serious medical illnesses that affect the ability of subjects to receive research programs, such as severe medical illnesses, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled high blood pressure, Uncontrolled infections, active peptic ulcers;
- Will hinder the understanding or make informed consent or fill in the questionnaire of dementia, mental state changes or any mental illness;
- Any history of allergic or hypersensitivity to any treatment ingredient;
- In the first 5 years of randomization, there were malignant tumors other than NSCLC, except for the treatment of basal cells or squamous cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ
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 |
|---|---|---|
| nab-paclitaxelAlso: keailialbumin-bound paclitaxel is 260 mg/m2 intravenously over 30 minutes on Days 1 of each 21-day cycle cycle immediately after albumin-bound paclitaxel | Drug | nab-paclitaxel plus carboplatin |
| PaclitaxelAlso: aosupaclitaxel is 175 mg/m2 intravenously over 3 hours on Days 1 of each 21-day cycle cycle immediately after paclitaxel | Drug | Paclitaxel plus carboplatin |
| CarboplatinAlso: bobeicarboplatin is administered on Day 1 of each 21-day，followed by paclitaxel or nab-paclitaxel | Drug | Paclitaxel plus carboplatin, nab-paclitaxel plus carboplatin |
Primary outcome
overall respond rate
Time frame: overall respond rate will be evaluated every 6 weeks until progression or new anti-cancer therapy initiation, up to 22 months.
the rate of CR and PR
3 secondary outcomes
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months
os
Time frame: From date of randomization until the date of death from any cause,assessed up to 18 months
Quality of life assessment
Time frame: It will be assessed before the administration of drugs at each first day of the chemotherapy cycle,up to 6 cycles,each cycle is 21 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
- Results publication: PubMed 22547591Socinski MA, Bondarenko I, Karaseva NA, Makhson AM, Vynnychenko I, Okamoto I, Hon JK, Hirsh V, Bhar P, Zhang H, Iglesias JL, Renschler MF. Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial. J Clin Oncol. 2012 Jun 10;30(17):2055-62. doi: 10.1200/JCO.2011.39.5848. Epub 2012 Apr 30.
- Individual participant dataSharing planned: No
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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, doctor principal investigator
Sun Yat-Sen University Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nab-paclitaxel, Paclitaxel and Carboplatin in people with Non-small Cell Lung Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
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 11 inclusion and 20 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 13 Nov 2017. 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 yumei wang, docter (+86 0311-67808816, wyumei73@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall respond rate (time frame: overall respond rate will be evaluated every 6 weeks until progression or new anti-cancer therapy initiation, up to 22 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03262948, which also lists 1 linked publication.
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 13 Nov 2017.