Non-small Cell Lung CancerPhase 2NCT01707329
Icotinib in Combination With Chemotherapy Versus Chemotherapy Alone in Patients Progressed After Icotinib Treatment
A Phase 2 study testing Chemotherapy and Icotinib+chemotherapy in people with Non-small Cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 6 sites in China.
Trial summary
This phase II randomised, double blind, placebo controlled, multicentre trial is designed to assess the efficacy and safety of continuous icotinib plus chemotherapy versus chemotherapy alone in patients who have progressed after benefiting from previous second or third-line icotinib treatment (more than 6 months) in… 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?
- Chemotherapy and Icotinib+chemotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 6 sitesChina
- Study dates
- Sep 2012to Dec 2016
- 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
- Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology)
- No previous targeted treatment such as gefitinib, erlotinib.
- With a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)and >=20mm with conventional CT) according to RECIST Criteria
- WHO performance status(PS)<= 2
- N>=1.5×109/L, Plt>=1.0×109/L,Hb>=10g/dL;AST\&ALT should <3ULN(without liver metastasis) or <5ULN(with liver metastasis).TBIL<=1.5ULN.
- Signed and dated informed consent before the start of specific protocol procedures.
Who cannot join
- Allergic to icotinib
- Patients with metastatic brain tumors with symptoms.
- Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab.
- Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 1 recruiting
- Active, not recruiting
Hunan Province Tumor Hospital
Changsha, Hunan, 410205
- Active, not recruiting
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310000
- Active, not recruiting
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang, 310000
- Active, not recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000
Zhang Yi Ping, M.D., 0086-13750881678, zyp@medmail.com.cn
Zhang Yi Ping, M.D.
- Active, not recruiting
The First Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325000
About this study
Official title: A Phase II Randomised, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Icotinib in Combination With Chemotherapy Versus Chemotherapy Alone in Patients Who Have Progressed After Icotinib Treatment in NSCLC
This phase II randomised, double blind, placebo controlled, multicentre trial is designed to assess the efficacy and safety of continuous icotinib plus chemotherapy versus chemotherapy alone in patients who have progressed after benefiting from previous second or third-line icotinib treatment (more than 6 months) in locally advanced or metastatic non-small cell lung cancer.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Chemotherapy, Icotinib+chemotherapy
- 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.
ChemotherapyDrug
Also called Taxotere, ALIMTA
Docetaxel 60-75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.
Icotinib+chemotherapyDrug
Also called Icotinib, Comana, BPI-2009
Icotinib: 125 mg is administered orally three times per day. Chemotherapy: docetaxel 75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Active comparator | Docetaxel 60-75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles. Receives: Drug: Chemotherapy |
| Icotinib+Chemotherapy | Experimental | Icotinib: 125 mg is administered orally three times per day. Chemotherapy: docetaxel 75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles. Receives: Drug: Icotinib+chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant
are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed.
Measured: 6 months
Secondary outcomes (1)
Overall survival
Overall Survival is assessed via calculation of the time to death due to any cause. If a participant is known to have died, the time to death is defined as the time from the date of randomization to the date of death. Otherwise, a participant will be censored at the last date they are known to be alive.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2016 (estimated)
- Study completionDec 2016 (estimated)
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 Betta Pharmaceuticals 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhang Yi Ping, M.D., Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707329
- Sponsor's protocol ID
- BD-IC-IV44
- Status last verified
- Sep 2015
- First submitted
- 11 Oct 2012
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomised, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Icotinib in Combination With Chemotherapy Versus Chemotherapy Alone in Patients Who Have Progressed After Icotinib Treatment in NSCLC
- ClinicalTrials.gov ID
- NCT01707329
- Acronym / sponsor ID
- BD-IC-IV44
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 16 Oct 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.
This phase II randomised, double blind, placebo controlled, multicentre trial is designed to assess the efficacy and safety of continuous icotinib plus chemotherapy versus chemotherapy alone in patients who have progressed after benefiting from previous second or third-line icotinib treatment (more than 6 months) in locally advanced or metastatic non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | Active comparator | Drug: ChemotherapyDocetaxel 60-75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles. |
| Icotinib+Chemotherapy | Experimental | Drug: Icotinib+chemotherapyIcotinib: 125 mg is administered orally three times per day. Chemotherapy: docetaxel 75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology)
- No previous targeted treatment such as gefitinib, erlotinib.
- With a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)and >=20mm with conventional CT) according to RECIST Criteria
- WHO performance status(PS)<= 2
- N>=1.5×109/L, Plt>=1.0×109/L,Hb>=10g/dL;AST\&ALT should <3ULN(without liver metastasis) or <5ULN(with liver metastasis).TBIL<=1.5ULN.
Key exclusion criteria (4 listed)
- Allergic to icotinib
- Patients with metastatic brain tumors with symptoms.
- Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab.
- Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
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 |
|---|---|---|
| ChemotherapyAlso: Taxotere, ALIMTADocetaxel 60-75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles. | Drug | Chemotherapy |
| Icotinib+chemotherapyAlso: Icotinib, Comana, BPI-2009Icotinib: 125 mg is administered orally three times per day. Chemotherapy: docetaxel 75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles. | Drug | Icotinib+Chemotherapy |
Primary outcome
Progression Free Survival
Time frame: 6 months
A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed.
1 secondary outcome
Overall survival
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 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.
Zhang Yi Ping, M.D. principal investigator
Zhejiang Cancer Hospital
6 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 Chemotherapy and Icotinib+chemotherapy in people with Non-small Cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 6 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 6 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 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhang Yi Ping, MD (0086-13750881678, zyp@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 6 months). 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 9 Sep 2015.