NSCLCPhase 2NCT01690390
Dose Escalation of Icotinib in Advanced Non-small Cell Lung Carcinoma (NSCLC) Patients Evaluated as Stable Disease
A Phase 2 study testing Icotinib of routine dose and Icotinib of high dose in people with NSCLC, run by Betta Pharmaceuticals Co., Ltd. at 17 sites in China.
Trial summary
The primary purposes of this study are to assess the safety and efficacy of using high doses of the drug Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer that achieve stable disease after 8 weeks routine therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- Icotinib of routine dose and Icotinib of high dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 17 sitesChina
- Study dates
- Sep 2012to Jul 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) at least 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
17 sites in 1 country.
17 sites in 1 country
China17 sites, 15 recruiting
- Recruiting
Hunan Provincal Cancer Hospital
Changsha, Hunan, 410006
Wu Lin, M.D., 0086-13706671349
Wu Lin, M.D.
- Recruiting
The Second People's Hospital of Sichuan
Chengdu, Sichuan, 610041
Yu Jingrui, M.D., 0086-13551237583
Yu Jingrui, M.D.
- Recruiting
Fujian Hospital for Chest Tumors & Tuberculosis Diseases
Fuzhou, Fujian, 350000
Chen Qun, M.D., 0086-13860669883
Chen Qun, M.D.
- Recruiting
Fujian Provincal Hospital
Fuzhou, Fujian, 350001
Cui Tongjian, M.D., 0086-13905920326
Cui Tongjian, M.D.
- Recruiting
Fujian Provincal Cancer Hospital
Fuzhou, Fujian, 350014
Huang Cheng, M.D., 0086-13905010397
Huang Cheng, M.D.
- Recruiting
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310000
Pan Minghong, M.D., 0086-57186006 ext. 922, panhongming@tom.com
Pan Minghong, M.D.
- Recruiting
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang, 310000
Zhou Jianying, M.D., 0086-13750881678, drzjy@163.com
Zhou Jianying, M.D.
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Huang Jianjin, M.D., 0086-13989889688, hhjj@medmail.com.cn
Huang Jianjin, M.D.
- 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
Zhejiang Traditional Chinese Medical Hospital
Hangzhou, Zhejiang, 310006
- Active, not recruiting
Zhejiang Hospital
Hangzhou, Zhejiang, 310007
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
Lu Li Qin, M.D., 0086-13858039628, llq99999@yahoo.com.cn
Lu Li Qin, M.D.
- Recruiting
Yinzhou People's Hospital
Ningbo, Zhejiang, 315040
Guo Jianxin, M.D., 0086-13605741696
Guo Jianxin, M.D.
- Recruiting
Ningbo Medical Treatment Center Lihuili Hospital
Ningbo, Zhejiang, 315046
Shen Weiyu, M.D., 0086-13805876129
Shen Weiyu, M.D.
- Recruiting
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 317000
Hu Wei, M.D., 0086-13606657129
Hu Wei, M.D.
- Recruiting
The First Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325000
Li Wenfeng, M.D., 0086-13968840592
Li Wenfeng, M.D.
- Recruiting
The second hospital of Xiamen City
Xiamen, Fujian, 361024
Ke Mingyao, M.D., 0086-13860166866
Ke Mingyao, M.D.
About this study
Official title: An Open-label, Randomized, Multicenter, Phase II Trial to Evaluate the Safety and Efficacy of Dose Escalation of Icotinib in Advanced or Metastatic NSCLC Patients After 8 Weeks Routine Therapy Evaluated as Stable Disease
The primary purposes of this study are to assess the safety and efficacy of using high doses of the drug Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer that achieve stable disease after 8 weeks routine therapy.
Read the detailed description
This is a multi-center phase II randomized controlled study to assess the safety and efficacy of using high doses of the drug Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer that achieve stable disease after 8 weeks routine therapy by PFS, as well as OS and DCR. The adverse events and adverse reaction are evaluated as well.
- Conditions
- NSCLC
- Being tested
- Icotinib of routine dose, Icotinib of high dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Icotinib of routine doseDrug
Also called Icotinib, Comana, BPI-2009
Icotinib of routine dose: 125 mg is administered orally three times per day.
Icotinib of high doseDrug
Also called Icotinib, Comana, BPI-2009
Icotinib: 250 mg is administered orally three times per day.
| Study group | Role | What they receive |
|---|---|---|
| Icotinib of Routine Dose | Active comparator | Oral Drug icotinib 125 mg three times per day Receives: Drug: Icotinib of routine dose |
| Icotinib of High Dose | Experimental | Oral Drug icotinib 250 mg three times per day Receives: Drug: Icotinib of high dose |
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 (3)
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: 15 months
Transformation rate from stable disease to complete response or partial response
Number of participants with an stable disease previously achieve complete response or partial response after dose escalation. Either complete response (CR) or partial response (PR) will be evaluated by RECIST, confirmed at least 28 days following the date of the initial response.
Measured: 6 weeks
Incidence rate of adverse events
Number of patients with a adverse event, identified according to the Common Toxicity Criteria (CTC) in evaluable-for-safety population, which included all patients who received at least 1 dose of study medication.
Measured: 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2015 (estimated)
- Study completionJul 2016 (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 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
- NCT01690390
- Sponsor's protocol ID
- BD-IV-43
- Status last verified
- Dec 2013
- First submitted
- 18 Sep 2012
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Multicenter, Phase II Trial to Evaluate the Safety and Efficacy of Dose Escalation of Icotinib in Advanced or Metastatic NSCLC Patients After 8 Weeks Routine Therapy Evaluated as Stable Disease
- ClinicalTrials.gov ID
- NCT01690390
- Acronym / sponsor ID
- BD-IV-43
- Conditions
- NSCLC
- 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
- Dec 2015 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 21 Sep 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.
The primary purposes of this study are to assess the safety and efficacy of using high doses of the drug Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer that achieve stable disease after 8 weeks routine therapy.
Detailed description
This is a multi-center phase II randomized controlled study to assess the safety and efficacy of using high doses of the drug Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer that achieve stable disease after 8 weeks routine therapy by PFS, as well as OS and DCR. The adverse events and adverse reaction are evaluated as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Icotinib of Routine Dose | Active comparator | Drug: Icotinib of routine doseOral Drug icotinib 125 mg three times per day |
| Icotinib of High Dose | Experimental | Drug: Icotinib of high doseOral Drug icotinib 250 mg three times per day |
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) at least 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 |
|---|---|---|
| Icotinib of routine doseAlso: Icotinib, Comana, BPI-2009Icotinib of routine dose: 125 mg is administered orally three times per day. | Drug | Icotinib of Routine Dose |
| Icotinib of high doseAlso: Icotinib, Comana, BPI-2009Icotinib: 250 mg is administered orally three times per day. | Drug | Icotinib of High Dose |
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.
3 secondary outcomes
Overall survival
Time frame: 15 months
Transformation rate from stable disease to complete response or partial response
Time frame: 6 weeks
Incidence rate of adverse events
Time frame: 40 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2014.
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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
17 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 Icotinib of routine dose and Icotinib of high dose in people with NSCLC, run by Betta Pharmaceuticals Co., Ltd. at 17 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 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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, M.D. (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 30 Dec 2014.