EGFR Positive Non-small Cell Lung CancerPhase 4NCT02103257
Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma
A Phase 4 study testing Sequential Icotinib Plus Chemotherapy and Icotinib in people with EGFR Positive Non-small Cell Lung Cancer and Adenocarcinoma, run by Betta Pharmaceuticals Co., Ltd. at 31 sites in China.
Trial summary
This randomised, controlled, multicentre trial is designed to assess the efficacy and safety of sequential icotinib plus chemotherapy versus single icotinib as first-line treatment in stage IIIB/IV lung adenocarcinoma patients with EGFR mutation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- EGFR Positive Non-small Cell Lung Cancer, Adenocarcinoma
- What is being tested?
- Sequential Icotinib Plus Chemotherapy and Icotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 31 sitesChina
- Study dates
- Mar 2014to Sep 2017
- Phase
- Phase 4
- 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
- Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT)
- Patients must have previously untreated locally advanced or metastatic NSCLC
- EGFR activating mutation (exon 19 deletion, L858R) is required
- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1
Who cannot join
- Prior chemotherapy or treatment with gefitinib, erlotinib, or other drugs that target EGFR
- Patients with wild-type EGFR
- Any other investigational agents are not permitted
- Any evidence of interstitial lung disease
Trial locations and contacts
31 sites in 1 country.
Helong Zhang, MD contact
31 sites in 1 country
China31 sites, 1 recruiting
- Active, not recruiting
Baoji Central Hospital
Baoji, Shanxi, 721008
- Active, not recruiting
General Hospital of Guangzhou Military Command
Guangzhou, Guangdong, 510010
- Active, not recruiting
Cancer Hospital of Sun Yat-sen
Guangzhou, Guangdong, 510060
- Active, not recruiting
First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, 510120
- Active, not recruiting
Hainan Provincal Nong Ken Hospital
Haikou, Hainan, 570311
- Active, not recruiting
Hainan Provincial People's Hospital
Haikou, Hainan, 570311
- Active, not recruiting
3201 Hospital, Hanzhong, Shanxi
Hanzhong, Shanxi, 723000
- Active, not recruiting
Jiangmen central hospital
Jiangmen, Guangdong, 529030
- Active, not recruiting
First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
- Active, not recruiting
Lanzhou military region general hospital
Lanzhou, Gansu, 730050
- Active, not recruiting
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
- Active, not recruiting
The university of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, 518000
- Active, not recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
- Active, not recruiting
Medical Oncology,Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035
- Active, not recruiting
Thoracic Surgery,Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035
- Active, not recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
- Active, not recruiting
Urumqi General Hospital of Lanzhou Military Region General Hospital
Ürümqi, Xinjiang, 830000
- Active, not recruiting
Xinjiang medical university affiliated tumor hospital
Ürümqi, Xinjiang, 830000
- Active, not recruiting
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054
- Active, not recruiting
Autonome Region Xinjiang Uygur Chinese medicine hospital
Ürümqi, Xinjiang, 830099
- Active, not recruiting
Shaanxi province people's hospital
Xi’an, Shanxi, 710000
- Active, not recruiting
Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710004
- Active, not recruiting
Xi'an Chang'an Hospital
Xi’an, Shanxi, 710018
- Recruiting
Tangdu Hospital，Fourth Military Medical University
Xi’an, Shanxi, 710038
Helong Zhang, MD, 13709202616
Helong Zhang, MD
- Active, not recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
- Active, not recruiting
Shanxi Cancer Hospital
Xi’an, Shanxi, 710061
- Active, not recruiting
Medical Oncology，General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
- Active, not recruiting
Radiation Oncology，General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
- Active, not recruiting
Respiratory medicine，General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
- Active, not recruiting
Guangdong Agribusiness Center Hospital
Zhanjiang, Guangdong, 524009
- Active, not recruiting
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma: a Randomized, Open-label, Multicenter Study
This randomised, controlled, multicentre trial is designed to assess the efficacy and safety of sequential icotinib plus chemotherapy versus single icotinib as first-line treatment in stage IIIB/IV lung adenocarcinoma patients with EGFR mutation.
- Being tested
- Sequential Icotinib Plus Chemotherapy, Icotinib
- Medical subject headings
- Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential Icotinib Plus ChemotherapyDrug
Also called ALIMTA, DDP, Comana, BPI-2009
Sequential icotinib plus chemotherapy: pemetrexed 500mg/m2 iv d1, cisplatin 75mg/m2 d1, icotinib 125 mg is administered orally three times per day d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4 cycles treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity.
IcotinibDrug
Also called Comana, BPI-2009
Icotinib 125 mg is administered orally three times per day until disease progression or intolerable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Sequential icotinib plus chemotherapy | Experimental | Sequential icotinib plus chemotherapy : pemetrexed 500mg/m2 iv d1, cisplatin 75mg/m2 d1, icotinib 125 mg is administered orally three times per day d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4 cycles treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity. Receives: Drug: Sequential Icotinib Plus Chemotherapy |
| Icotinib | Active comparator | Icotinib 125 mg is administered orally three times per day until disease progression or intolerable toxicity. Receives: Drug: Icotinib |
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: 15 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: 24 months
Objective response rate
Number of subjects with confirmed objective response according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Measured: 15 months
Adverse events
The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2016 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR Positive Non-small Cell Lung CancerStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helong Zhang, MD, Principal investigator, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103257
- Sponsor's protocol ID
- BD-IC-IV62
- Status last verified
- Apr 2015
- First submitted
- 31 Mar 2014
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma: a Randomized, Open-label, Multicenter Study
- ClinicalTrials.gov ID
- NCT02103257
- Acronym / sponsor ID
- BD-IC-IV62
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 3 Apr 2014 (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 randomised, controlled, multicentre trial is designed to assess the efficacy and safety of sequential icotinib plus chemotherapy versus single icotinib as first-line treatment in stage IIIB/IV lung adenocarcinoma patients with EGFR mutation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequential icotinib plus chemotherapy | Experimental | Drug: Sequential Icotinib Plus ChemotherapySequential icotinib plus chemotherapy : pemetrexed 500mg/m2 iv d1, cisplatin 75mg/m2 d1, icotinib 125 mg is administered orally three times per day d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4 cycles treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity. |
| Icotinib | Active comparator | Drug: IcotinibIcotinib 125 mg is administered orally three times per day until disease progression or intolerable toxicity. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT)
- Patients must have previously untreated locally advanced or metastatic NSCLC
- EGFR activating mutation (exon 19 deletion, L858R) is required
- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1
Key exclusion criteria (4 listed)
- Prior chemotherapy or treatment with gefitinib, erlotinib, or other drugs that target EGFR
- Patients with wild-type EGFR
- Any other investigational agents are not permitted
- Any evidence of interstitial lung disease
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 |
|---|---|---|
| Sequential Icotinib Plus ChemotherapyAlso: ALIMTA, DDP, Comana, BPI-2009Sequential icotinib plus chemotherapy: pemetrexed 500mg/m2 iv d1, cisplatin 75mg/m2 d1, icotinib 125 mg is administered orally three times per day d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4 cycles treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity. | Drug | Sequential icotinib plus chemotherapy |
| IcotinibAlso: Comana, BPI-2009Icotinib 125 mg is administered orally three times per day until disease progression or intolerable toxicity. | Drug | Icotinib |
Primary outcome
Progression Free Survival
Time frame: 15 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: 24 months
Objective response rate
Time frame: 15 months
Adverse events
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 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.
Helong Zhang, MD contact
Helong Zhang, MD principal investigator
Tang-Du Hospital
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sequential Icotinib Plus Chemotherapy and Icotinib in people with EGFR Positive Non-small Cell Lung Cancer and Adenocarcinoma, run by Betta Pharmaceuticals Co., Ltd. at 31 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 4 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 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Helong Zhang, MD (13709202616), 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: 15 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 29 Apr 2015.