Non-small Cell Lung CancerPhase 2ICAPENCT02044328
Icotinib as an Adjuvant Therapy for Patients With Stage IIA-IIIA Adenocarcinoma With EGFR Mutation
A Phase 2 study testing Icotinib in people with Non-small Cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
Adjuvant therapy has been proved effective in treating earlier stage or less advanced non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating stage IIA-IIIA adenocarcinoma patients with EGFR mutation. The primary endpoint is disease-free survival. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Oct 2021
- 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 present with operable stage IIA-IIIA (N0-1) lung adenocarcinoma 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 ≤ 0-1
- The patients signed the written informed consent
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
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
About this study
Official title: Icotinib as an Adjuvant Therapy for Patients With Stage IIA-IIIA Adenocarcinoma With EGFR Mutation: a Prospective, Exploratory Study
Adjuvant therapy has been proved effective in treating earlier stage or less advanced non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating stage IIA-IIIA adenocarcinoma patients with EGFR mutation. The primary endpoint is disease-free survival.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- 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.
IcotinibDrug
Also called Commana, BPI-2009
Icotinib is administered 125 mg three times per day.
| Study group | Role | What they receive |
|---|---|---|
| Icotinib | Experimental | Patients receive icotinib 125 mg three times daily as adjuvant chemotherapy with for 18 months after surgery. Receives: Drug: Icotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Measured: 2 years
Secondary outcomes (3)
1-year Survival Rates
Measured: 1 year
3-year Survival Rates
Measured: 3 years
Number of patients suffered adverse events
Adverse events are evaluated and coded by Common Terminology Criteria for Adverse Events version 4.0
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2018
- Study completionOct 2021
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhang Yi, MD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044328
- Sponsor's protocol ID
- BD-IC-IV57
- Acronym
- ICAPE
- Status last verified
- Jan 2022
- First submitted
- 21 Jan 2014
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Icotinib as an Adjuvant Therapy for Patients With Stage IIA-IIIA Adenocarcinoma With EGFR Mutation: a Prospective, Exploratory Study
- ClinicalTrials.gov ID
- NCT02044328
- Acronym / sponsor ID
- ICAPE / BD-IC-IV57
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2014 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Oct 2021 (actual)
- First posted
- 23 Jan 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.
Adjuvant therapy has been proved effective in treating earlier stage or less advanced non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating stage IIA-IIIA adenocarcinoma patients with EGFR mutation. The primary endpoint is disease-free survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Icotinib | Experimental | Drug: IcotinibPatients receive icotinib 125 mg three times daily as adjuvant chemotherapy with for 18 months after surgery. |
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 present with operable stage IIA-IIIA (N0-1) lung adenocarcinoma 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 ≤ 0-1
- The patients signed the written informed consent
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 |
|---|---|---|
| IcotinibAlso: Commana, BPI-2009Icotinib is administered 125 mg three times per day. | Drug | Icotinib |
Primary outcome
Disease-free survival
Time frame: 2 years
3 secondary outcomes
1-year Survival Rates
Time frame: 1 year
3-year Survival Rates
Time frame: 3 years
Number of patients suffered adverse events
Time frame: 42 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
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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, MD principal investigator
Xuanwu Hospital, Beijing
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 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: finished, as of the sponsor's last update on 8 Feb 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Disease-free survival (time frame: 2 years). 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 8 Feb 2022.