Non-small-cell Lung CancerPhase 2NCT01836679
Chidamide in Combination With Carboplatin and Paclitaxel in Advanced Non-small Cell Lung Cancer
A Phase 2 study testing Chidamide, Paclitaxel and Carboplatin in people with Non-small-cell Lung Cancer, run by Chipscreen Biosciences, Ltd. at 8 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Chidamide combined with paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small-cell Lung Cancer
- What is being tested?
- Chidamide, Paclitaxel and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 8 sitesChina
- Study dates
- Apr 2013to Dec 2015
- Phase
- Phase 2
- 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
- Patients with histology or cytology confirmed non-small-cell lung cancer,stage IIIb or IV. Newly diagnosed or relapsed after surgery but have not received systemic drug therapy.Adjuvant chemotherapy after surgery should have completed for more than one year at study entry.
- Aged 18~75 years
- Epidermal growth factor receptor (EGFR) mutation negative or EGFR status is unknown
- With at least one measurable lesion
- White blood cell count≥4×10^9/L,platelet count≥100×10^9/L and hemoglobin≥11g/L
- Life expectancy >3 months
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- Eastern Cooperative Oncology Group performance status of ≤1 at study entry
- Women of childbearing age should have pregnancy test negative and would like to conduct birth control during the study
- Have signed informed consent
Who cannot join
- Patients with clinically significant corrected QT interval prolongation, or ventricular tachycardia,or auricular fibrillation, or ≥Grade 2 sino-auricular heart-block,or ≥Grade 3 atrioventricular block,or myocardial infarction within one year, or congestive heart failure,or patients with symptomatic coronary disease which need to be treated by drug
- The size of fluid area detected by cardiac ultrasonography in cavum pericardium is ≥10mm during diastolic period
- Organ transplant patients
- Patients with active bleeding or new thrombotic diseases
- Patients with body temperature >38.5℃ for more than 3 days
- Total bilirubin >1.5 fold of upper limit of normal (ULN), ALT/AST>1.5 fold of ULN or serum creatine >1.5 fold of ULN
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- Patients with symptomatic brain-metastasis
- Pregnant or lactating women
- Patients with mental disorder
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, 101149
The Second People's Hospital of Sichuan
Chengdu, Sichuan, 82816
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009
Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200030
The first Hospital of China Medical University
Shenyang, Liaoning, 110001
Hebei Provincial Tumor Hospital
Shijiazhuang, Hebei, 050011
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
About this study
Official title: A Phase II Study of Chidamide or Placebo in Combination With Carboplatin and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer
The purpose of this study is to evaluate the efficacy and safety of Chidamide combined with paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer.
Read the detailed description
The study is to evaluate efficacy which includes the progression free survival (PFS), PFS at 6 months, objective response rate, duration of response rate, overall survival and time to progression, and safety which include adverse events, vital signs, laboratory tests, of the treatment of chidamide plus paclitaxel and carboplatin in patients with advanced non small cell lung cancer.
- Conditions
- Non-small-cell Lung Cancer
- Being tested
- Chidamide, Paclitaxel, Carboplatin, Placebo
- Keywords
- Chidamide,lung cancer
- 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.
ChidamideDrug
Also called CS055
Given orally
PaclitaxelDrug
Also called Taxol, TAX
Given IV
CarboplatinDrug
Also called CBDCA, Paraplatin
Given IV
PlaceboDrug
Also called PLB
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.The chemotherapy cycles are repeated every 3 weeks to a maximum of 4 cycles. Patients also receive Chidamide 20mg orally twice a week until disease progression,or unacceptable toxicities,or withdrawal of consent occurred. Receives: Drug: Chidamide; Drug: Paclitaxel; Drug: Carboplatin |
| Arm 2 | Placebo comparator | Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.The chemotherapy cycles are repeated every 3 weeks to a maximum of 4 cycles. Patients also receive placebo orally twice a week until disease progression,or unacceptable toxicities,or withdrawal of consent occurred. Receives: Drug: Paclitaxel; Drug: Carboplatin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS is measured from the start of treatment until progression or death,whichever is first met
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 76 weeks
Secondary outcomes (5)
Progression-Free Survival Rate at 6 Months (6-M-PFS)
6-M-PFS is defined as the percentage of participants whose disease is still progression-free at the 6th month
Measured: 6 months
Object Response Rate (ORR)
ORR is defined as percentage of participants with Complete Response and Partial Response,assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: Response is assessed once every 6 weeks (combination therapy period) for up to 12 weeks, and once every 8 weeks (maintenance therapy period) for up to 64 weeks
Duration of Response (DOR)
DOR is measured from the first date when criteria for response is met until the first date when the criteria for progression is met
Measured: From the first date of response until the date of first documented progression, assessed up to 70 weeks
Overall Survival (OS)
OS is measured from the start of treatment until death
Measured: From date of randomization until the date of death from any cause, followed for up to 76 weeks
Time To Progression (TTP) during the maintenance therapy period
TTP is assessed for patients who complete the 12 weeks of combination therapy. It is measured from the start of maintenance therapy until the criteria of progression is met
Measured: From the start date of maintenance therapy until the date of first documented progression, assessed up to 64 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionMay 2015
- Study completionDec 2015
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 Chipscreen Biosciences, 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chipscreen Biosciences, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuankai Shi, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836679
- Sponsor's protocol ID
- CDM204
- Status last verified
- Jan 2016
- First submitted
- 12 Apr 2013
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Chidamide or Placebo in Combination With Carboplatin and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01836679
- Acronym / sponsor ID
- CDM204
- Conditions
- Non-small-cell Lung Cancer
- Keywords
- Chidamide,lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Chipscreen Biosciences, Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Apr 2013 (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.
The purpose of this study is to evaluate the efficacy and safety of Chidamide combined with paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer.
Detailed description
The study is to evaluate efficacy which includes the progression free survival (PFS), PFS at 6 months, objective response rate, duration of response rate, overall survival and time to progression, and safety which include adverse events, vital signs, laboratory tests, of the treatment of chidamide plus paclitaxel and carboplatin in patients with advanced non small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Chidamide, Drug: Paclitaxel, Drug: CarboplatinPatients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.The chemotherapy cycles are repeated every 3 weeks to a maximum of 4 cycles. Patients also receive Chidamide 20mg orally twice a week until disease progression,or unacceptable toxicities,or withdrawal of consent occurred. |
| Arm 2 | Placebo comparator | Drug: Paclitaxel, Drug: Carboplatin, Drug: PlaceboPatients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.The chemotherapy cycles are repeated every 3 weeks to a maximum of 4 cycles. Patients also receive placebo orally twice a week until disease progression,or unacceptable toxicities,or withdrawal of consent occurred. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with histology or cytology confirmed non-small-cell lung cancer,stage IIIb or IV. Newly diagnosed or relapsed after surgery but have not received systemic drug therapy.Adjuvant chemotherapy after surgery should have completed for more than one year at study entry.
- Aged 18~75 years
- Epidermal growth factor receptor (EGFR) mutation negative or EGFR status is unknown
- With at least one measurable lesion
- White blood cell count≥4×10^9/L,platelet count≥100×10^9/L and hemoglobin≥11g/L
Key exclusion criteria (9 listed)
- Patients with clinically significant corrected QT interval prolongation, or ventricular tachycardia,or auricular fibrillation, or ≥Grade 2 sino-auricular heart-block,or ≥Grade 3 atrioventricular block,or myocardial infarction within one year, or congestive heart failure,or patients with symptomatic coronary disease which need to be treated by drug
- The size of fluid area detected by cardiac ultrasonography in cavum pericardium is ≥10mm during diastolic period
- Organ transplant patients
- Patients with active bleeding or new thrombotic diseases
- Patients with body temperature >38.5℃ for more than 3 days
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 |
|---|---|---|
| ChidamideAlso: CS055Given orally | Drug | Arm 1 |
| PaclitaxelAlso: Taxol, TAXGiven IV | Drug | Arm 1, Arm 2 |
| CarboplatinAlso: CBDCA, ParaplatinGiven IV | Drug | Arm 1, Arm 2 |
| PlaceboAlso: PLBGiven orally | Drug | Arm 2 |
Primary outcome
Progression-Free Survival (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 76 weeks
PFS is measured from the start of treatment until progression or death,whichever is first met
5 secondary outcomes
Progression-Free Survival Rate at 6 Months (6-M-PFS)
Time frame: 6 months
Object Response Rate (ORR)
Time frame: Response is assessed once every 6 weeks (combination therapy period) for up to 12 weeks, and once every 8 weeks (maintenance therapy period) for up to 64 weeks
Duration of Response (DOR)
Time frame: From the first date of response until the date of first documented progression, assessed up to 70 weeks
Overall Survival (OS)
Time frame: From date of randomization until the date of death from any cause, followed for up to 76 weeks
Time To Progression (TTP) during the maintenance therapy period
Time frame: From the start date of maintenance therapy until the date of first documented progression, assessed up to 64 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2016.
- 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.
Yuankai Shi principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chidamide, Paclitaxel and Carboplatin in people with Non-small-cell Lung Cancer, run by Chipscreen Biosciences, Ltd. at 8 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 9 inclusion and 9 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: finished, as of the sponsor's last update on 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 76 weeks). 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 1 Feb 2016.