Non-small-cell Lung CancerPhase 2NCT01929200
Icotinib as Adjuvant Therapy in Treating Non-small-cell Lung Cancer Patients With Positive EGFR Mutation
A Phase 2 study testing 1-year treatment with icotinib and 2-year treatment with icotinib in people with Non-small-cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating such patients. The primary endpoint is to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib. 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?
- 1-year treatment with icotinib and 2-year treatment with icotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Aug 2013to Aug 2017
- 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
- The patients signed the written informed consent
- The patients present with operable stage II-IIIA non-small-cell lung cancers with 19 or 21 exon mutation
- The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy
- The patients' Eastern Cooperative Oncology Group scores are ≤ 0-2
Who cannot join
- Patients with unresected tumor
- Wild EGFR type
- Allergic to the study drug
- Patients have severe non-cancerous diseases
- Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer hospital
Beijing, 100142
Yue Yang, MD, 86-10-88196568, zlyangyue@bjmu.edu.cn
Yue Yang, MD
About this study
Official title: Randomized, Open-label, Multicenter Study of Icotinib as Adjuvant Therapy in Treating Stage II-IIIA Non-small-cell Lung Cancer Patients With Positive EGFR Mutation
This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating such patients. The primary endpoint is to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib.
Read the detailed description
Adjuvant therapy has been proved effective in treating stage II-IIIA non-small-cell lung cancer. However, few data on the treating time of adjuvant therapy is available. Here we conduct a randomized, prospective study to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib in EGFR-mutated non-small cell lung cancer patients.
- Conditions
- Non-small-cell Lung Cancer
- Being tested
- 1-year treatment with icotinib, 2-year treatment with icotinib
- 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.
1-year treatment with icotinibDrug
Also called Commana, BPI-2009
Icotinib is administered orally with a dose 125 mg 3 times daily within 4-6 weeks after operation for 1 year.
2-year treatment with icotinibDrug
Also called Commana, BPI-2009
Icotinib is administered orally with a dose 125 mg 3 times daily within 4-6 weeks after operation for 2 years.
| Study group | Role | What they receive |
|---|---|---|
| 1-year treatment with icotinib | Experimental | Patients will receive 1-year treatment with icotinib after operation. Receives: Drug: 1-year treatment with icotinib |
| 2-year treatment with icotinib | Experimental | Patients will receive 2-year treatment with icotinib after operation. Receives: Drug: 2-year treatment with icotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free Survival
Measured: 6 months
Secondary outcomes (1)
Overall survival
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2015 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Yue Yang, MD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929200
- Sponsor's protocol ID
- BD-IC-IV50
- Status last verified
- May 2015
- First submitted
- 21 Aug 2013
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lv C, Ma Y, Feng Q, Fang F, Bai H, Zhao B, Yan S, Wu N, Zheng Q, Li S, Chen J, Wang J, Feng Y, Wang Y, Pei Y, Fang J, Yang Y. A pilot study: sequential gemcitabine/cisplatin and icotinib as induction therapy for stage IIB to IIIA non-small-cell lung adenocarcinoma. World J Surg Oncol. 2013 Apr 26;11:96. doi: 10.1186/1477-7819-11-96.
PubMed 23621919Lv C, Wang R, Li S, Yan S, Wang Y, Chen J, Wang L, Liu Y, Guo Z, Wang J, Pei Y, Yu L, Wu N, Lu F, Gao F, Chen J, Liu Y, Wang X, Li S, Han B, Zhang L, Ma Y, Ding L, Wang Y, Yuan X, Yang Y. Randomized phase II adjuvant trial to compare two treatment durations of icotinib (2 years versus 1 year) for stage II-IIIA EGFR-positive lung adenocarcinoma patients (ICOMPARE study). ESMO Open. 2023 Aug;8(4):101565. doi: 10.1016/j.esmoop.2023.101565. Epub 2023 Jun 20.
PubMed 37348348
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-label, Multicenter Study of Icotinib as Adjuvant Therapy in Treating Stage II-IIIA Non-small-cell Lung Cancer Patients With Positive EGFR Mutation
- ClinicalTrials.gov ID
- NCT01929200
- Acronym / sponsor ID
- BD-IC-IV50
- 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 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 27 Aug 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.
This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating such patients. The primary endpoint is to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib.
Detailed description
Adjuvant therapy has been proved effective in treating stage II-IIIA non-small-cell lung cancer. However, few data on the treating time of adjuvant therapy is available. Here we conduct a randomized, prospective study to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib in EGFR-mutated non-small cell lung cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-year treatment with icotinib | Experimental | Drug: 1-year treatment with icotinibPatients will receive 1-year treatment with icotinib after operation. |
| 2-year treatment with icotinib | Experimental | Drug: 2-year treatment with icotinibPatients will receive 2-year treatment with icotinib after operation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patients signed the written informed consent
- The patients present with operable stage II-IIIA non-small-cell lung cancers with 19 or 21 exon mutation
- The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy
- The patients' Eastern Cooperative Oncology Group scores are ≤ 0-2
Key exclusion criteria (5 listed)
- Patients with unresected tumor
- Wild EGFR type
- Allergic to the study drug
- Patients have severe non-cancerous diseases
- Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials
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 |
|---|---|---|
| 1-year treatment with icotinibAlso: Commana, BPI-2009Icotinib is administered orally with a dose 125 mg 3 times daily within 4-6 weeks after operation for 1 year. | Drug | 1-year treatment with icotinib |
| 2-year treatment with icotinibAlso: Commana, BPI-2009Icotinib is administered orally with a dose 125 mg 3 times daily within 4-6 weeks after operation for 2 years. | Drug | 2-year treatment with icotinib |
Primary outcome
Recurrence-free Survival
Time frame: 6 months
1 secondary outcome
Overall survival
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
- Background: PubMed 23621919Lv C, Ma Y, Feng Q, Fang F, Bai H, Zhao B, Yan S, Wu N, Zheng Q, Li S, Chen J, Wang J, Feng Y, Wang Y, Pei Y, Fang J, Yang Y. A pilot study: sequential gemcitabine/cisplatin and icotinib as induction therapy for stage IIB to IIIA non-small-cell lung adenocarcinoma. World J Surg Oncol. 2013 Apr 26;11:96. doi: 10.1186/1477-7819-11-96.
- Derived from this study: PubMed 37348348Lv C, Wang R, Li S, Yan S, Wang Y, Chen J, Wang L, Liu Y, Guo Z, Wang J, Pei Y, Yu L, Wu N, Lu F, Gao F, Chen J, Liu Y, Wang X, Li S, Han B, Zhang L, Ma Y, Ding L, Wang Y, Yuan X, Yang Y. Randomized phase II adjuvant trial to compare two treatment durations of icotinib (2 years versus 1 year) for stage II-IIIA EGFR-positive lung adenocarcinoma patients (ICOMPARE study). ESMO Open. 2023 Aug;8(4):101565. doi: 10.1016/j.esmoop.2023.101565. Epub 2023 Jun 20.
Related trials for Non-small-cell Lung Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2/3
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
RecruitingPhase 3
A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)
Non-small Cell Lung Cancer
Recruiting
Understanding the Feasibility of a Co-designed Pre-radiotherapy Exercise Programme - A Single-arm Study
Lung Cancer
RecruitingPhase 2
Adjuvant ctDNA-Adapted Personalized Treatment in Early Stage NSCLC (ADAPT-E)
Non-small Cell Lung Cancer, Non-small Cell Lung Cancer Stage I
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.
Yue Yang, MD principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1-year treatment with icotinib and 2-year treatment with icotinib in people with Non-small-cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 1 site 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 5 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 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Yue Yang, MD (86-10-88196568, zlyangyue@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-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?
On the ClinicalTrials.gov record for NCT01929200, which also lists 2 linked publications.
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 22 May 2015.