Non-small Cell Lung CancerPhase 2NCT02215356
Icotinib With Concurrent Radiotherapy Versus Chemotherapy With Concurrent Radiotherapy in Non-small Cell Lung Cancer
A Phase 2 study testing Icotinib with concurrent radiotherapy and Chemoradiotherapy in people with Non-small Cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 26 sites in China.
Trial summary
This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus chemotherapy with concurrent radiotherapy in 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?
- Icotinib with concurrent radiotherapy and Chemoradiotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 26 sitesChina
- Study dates
- Aug 2014to Feb 2019
- 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
- Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 mutation
- No previous systemic anticancer therapy
- Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site
- ECOG Performance Status of 0 to 1
Who cannot join
- Prior treatment with anti-EGFR (the epidermal growth factor receptor) monoclonal antibody or small molecular compounds therapy such as gefitinib, erlotinib or cetuximab
- Evidence of clinically active Interstitial Lung Diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
- Known severe hypersensitivity to icotinib or any of the excipients of this product
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
China26 sites
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing Municipality, 100021
People's Liberation Army 307 Hospital
Beijing, Beijing Municipality, 100039
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Beijing Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Tumor Hospital of Jilin Province
Changchun, Jilin, 130012
Hunan Provincial Tumor Hospital
Changsha, Hunan, 410013
Sichuan Provincial Tumor Hospital
Chengdu, Sichuan, 610041
Dongguan City People's Hospital
Dongguan, Guangdong, 523059
Sun Yat-sen Cancer Hospital
Guangzhou, Guangdong, 510060
Nanfang Hospital
Guangzhou, Guangdong, 510515
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310006
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, 150081
Tumor Hospital of Yunnan Province
Kunming, Yunnan, 650118
Jiangxi Provincial Cancer Hospital
Nanchang, Jiangxi, 330029
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009
Guangxi Zhuang Autonomous Region People's Hospital
Nanning, Guangxi, 530021
Nantong Tumor Hospital
Nantong, Jiangsu, 226361
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
Liaoning Provincial Tumor Hospital
Shenyang, Liaoning, 110042
Shanxi Tumor Hospital
Taiyuan, Shanxi, 030013
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000
Tongji Hospital
Wuhan, Hubei, 430030
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: Icotinib With Concurrent Radiotherapy Versus Etoposide/Cisplatin With Concurrent Radiotherapy in Stage III Non-small Cell Lung Cancer With EGFR 19/21 Mutation
This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus chemotherapy with concurrent radiotherapy in non-small cell lung cancer
Read the detailed description
This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus etoposide/cisplatin with concurrent radiotherapy in stage III non-small cell lung cancer with EGFR 19/21 Mutation, the primary endpoint is progression-free survival
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Icotinib with concurrent radiotherapy, Chemoradiotherapy
- 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.
Icotinib with concurrent radiotherapyDrug
Also called Icotinib, Comana, BPI-2009
Icotinib: 125 mg is administered orally three times per day.
ChemoradiotherapyDrug
Also called VP16, DDP
Etoposide 50mg/m2, ivgtt, d1-d5; cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles
| Study group | Role | What they receive |
|---|---|---|
| Chemoradiotherapy | Active comparator | Etoposide 50mg/m2, ivgtt, d1-d5, cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles, while chest radiotherapy (total dose 60-66Gy, 2Gy per time, once a day, five times a week, a total of 30-33 times). Progressive patients will be administered oral icotinib 125 mg three times daily. Receives: Drug: Chemoradiotherapy |
| Icotinib with concurrent radiotherapy | Experimental | Chest radiotherapy (total dose 60-66Gy, 2Gy per time, once a day, five times a week, a total of 30-33 times), while icotinib 125mg three times daily (375 mg per day) by mouth. Maintenance icotinib will be administered after radiotherapy. Progressive patients will receive chemotherapy, using the platinum-based two-drug chemotherapy regimen. Receives: Drug: Icotinib with concurrent radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 24 months
Secondary outcomes (3)
Overall survival
Measured: 36 months
Objective response rate
Measured: 8 weeks
Adverse events
Measured: 54 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2018 (estimated)
- Study completionFeb 2019 (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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lvhua Wang, MD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical SciencesXiaolong Fu, MD, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215356
- Sponsor's protocol ID
- BD-IC-IV66
- Status last verified
- Aug 2014
- First submitted
- 11 Aug 2014
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Icotinib With Concurrent Radiotherapy Versus Etoposide/Cisplatin With Concurrent Radiotherapy in Stage III Non-small Cell Lung Cancer With EGFR 19/21 Mutation
- ClinicalTrials.gov ID
- NCT02215356
- Acronym / sponsor ID
- BD-IC-IV66
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 13 Aug 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, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus chemotherapy with concurrent radiotherapy in non-small cell lung cancer
Detailed description
This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus etoposide/cisplatin with concurrent radiotherapy in stage III non-small cell lung cancer with EGFR 19/21 Mutation, the primary endpoint is progression-free survival
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemoradiotherapy | Active comparator | Drug: ChemoradiotherapyEtoposide 50mg/m2, ivgtt, d1-d5, cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles, while chest radiotherapy (total dose 60-66Gy, 2Gy per time, once a day, five times a week, a total of 30-33 times). Progressive patients will be administered oral icotinib 125 mg three times daily. |
| Icotinib with concurrent radiotherapy | Experimental | Drug: Icotinib with concurrent radiotherapyChest radiotherapy (total dose 60-66Gy, 2Gy per time, once a day, five times a week, a total of 30-33 times), while icotinib 125mg three times daily (375 mg per day) by mouth. Maintenance icotinib will be administered after radiotherapy. Progressive patients will receive chemotherapy, using the platinum-based two-drug chemotherapy regimen. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 mutation
- No previous systemic anticancer therapy
- Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site
- ECOG Performance Status of 0 to 1
Key exclusion criteria (3 listed)
- Prior treatment with anti-EGFR (the epidermal growth factor receptor) monoclonal antibody or small molecular compounds therapy such as gefitinib, erlotinib or cetuximab
- Evidence of clinically active Interstitial Lung Diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
- Known severe hypersensitivity to icotinib or any of the excipients of this product
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 with concurrent radiotherapyAlso: Icotinib, Comana, BPI-2009Icotinib: 125 mg is administered orally three times per day. | Drug | Icotinib with concurrent radiotherapy |
| ChemoradiotherapyAlso: VP16, DDPEtoposide 50mg/m2, ivgtt, d1-d5; cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles | Drug | Chemoradiotherapy |
Primary outcome
Progression-free survival
Time frame: 24 months
3 secondary outcomes
Overall survival
Time frame: 36 months
Objective response rate
Time frame: 8 weeks
Adverse events
Time frame: 54 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 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.
Lvhua Wang, MD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Xiaolong Fu, MD principal investigator
Shanghai Chest Hospital
26 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 with concurrent radiotherapy and Chemoradiotherapy in people with Non-small Cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 26 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 3 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 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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?
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 (time frame: 24 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 13 Aug 2014.