EGFR Positive Non-small Cell Lung CancerPhase 3ICWIPNCT02125240
Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma
A Phase 3 study testing Icotinib in people with EGFR Positive Non-small Cell Lung Cancer and Adenocarcinoma, run by Betta Pharmaceuticals Co., Ltd. at 11 sites in China.
Trial summary
The purpose of this study is to compare 3years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma. 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?
- Icotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 11 sitesChina
- Study dates
- Sep 2014to Jul 2021
- Phase
- Phase 3
- 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
- Pathologically confirmed lung adenocarcinoma after surgical resection
- Stage II-IIIA disease according to 7th edition of TNM staging
- Patients must harbor sensitive EGFR gene mutation (19/21)
- Received four cycles of platinum-based adjuvant chemotherapy.There are many different kinds of chemotherapy regimens including vinorelbine, gemcitabine, docetaxel, paclitaxel, pemetrexed plus cisplatin or carboplatin.The first cycle of chemotherapy with cisplatin dose of 75 mg / m2 ± 10% or carboplatin AUC = 5 ± 10% to calculate the dose of chemotherapy
Who cannot join
- Previous systemic anti-tumor therapy, including chemotherapy or targeted therapy(Including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitor, etc
- Presence of metastatic disease
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- Any unresolved chronic toxicity from previous anticancer therapy
- Received antitumor radiation therapy (except for the stage IIIA N2 patients who received adjuvant radiotherapy after surgery)
Trial locations and contacts
11 sites in 1 country.
Yuan-Kai Shi, MD contact
11 sites in 1 country
China11 sites, 11 recruiting
- Recruiting
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100000
Hui Li, MD
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100005
Gang Cheng, MD
- Recruiting
Beijing Union Medical College Hospital
Beijing, Beijing Municipality, 100005
Li Zhang, MD
- Recruiting
Cancer Hospital, Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021
Yuan-Kai Shi, MD
- Recruiting
China-japan friendship hospital in Beijing
Beijing, Beijing Municipality, 100029
De-Ruo Liu, MD
- Not yet recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Jian Li, MD
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Jun Wang, MD
- Recruiting
304 Hospital of PLA
Beijing, Beijing Municipality, 100048
Wen-Hua Xiao, MD
- Not yet recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Xiu-Yi Zhi, MD
- Not yet recruiting
People's Liberation Army General Hospital (301 Hospital)
Beijing, Beijing Municipality, 100853
Yi Hu, MD
- Recruiting
Capital Medical University, Beijing Chest Hospital
Beijing, Beijing Municipality, 101149
Shu-Cai Zhang, MD
About this study
Official title: Icotinib as an Adjuvant Therapy for Stage II-IIIA Adenocarcinoma With EGFR Mutation: A Placebo-controlled, Randomized, Double-blind, Phase III Study
The purpose of this study is to compare 3years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.
Read the detailed description
This study is designed to compare 3 years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.
Primary Outcome Measure:
Disease-free survival between Icotinib group and placebo group.
Secondary Outcome Measures:
Overall survival between Icotinib group and placebo group. Lung cancer symptoms and health-related quality of life (HRQoL) . Number of participants with adverse events.
- Being tested
- Icotinib, Placebo
- Medical subject headings
- Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcotinibDrug
Also called BPI-2009, Conmana
125 mg three times daily (375 mg per day) by mouth
PlaceboDrug
1 tablet three times daily by mouth
| Study group | Role | What they receive |
|---|---|---|
| Icotinib | Experimental | 125 mg three times daily (375 mg per day) by mouth Receives: Drug: Icotinib |
| Placebo | Active comparator | 1 tablet three times daily by mouth Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
DFS was defined as the time from the date of first dose of study medication to the date of death due to disease recurrence or disease progression.
Measured: 36 months
Secondary outcomes (3)
Overall survival
OS was assessed via calculation of the time to death due to any cause from the date of randomization. A patient was censored at the last date they were known to be alive.
Measured: 60 months
Lung cancer symptoms and health-related quality of life (HRQoL) differences
Measured: 60 months
Number of participants with adverse events
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2018 (estimated)
- Study completionJul 2021 (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 EGFR Positive 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuan-Kai Shi, MD, Principal investigator, Cancer Hospital Chinese Academy of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125240
- Sponsor's protocol ID
- BD-IC-IV-59
- Acronym
- ICWIP
- Status last verified
- Jul 2018
- First submitted
- 24 Apr 2014
- Last updated
- 16 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liu YT, Tang L, Han XH, Song ZY, Liu DR, Cheng G, Xiao WH, Zhang SC, Hu Y, Zhang L, Liu JF, Wang J, Dong GL, Shi YK. Three-year adjuvant treatment of icotinib in stage II-IIIA EGFR-mutated lung adenocarcinoma (ICWIP): a randomized, double-blind, placebo-controlled phase 3 trial. Signal Transduct Target Ther. 2026 Aug 28;11(1):354. doi: 10.1038/s41392-026-02994-w.
PubMed 42660909Liu YT, Hao XZ, Liu DR, Cheng G, Zhang SC, Xiao WH, Hu Y, Liu JF, He M, Ding CM, Zhang L, Wang J, Li H, Dong GL, Zhi XY, Li J, Shi YK. Icotinib as Adjuvant Treatment for Stage II-IIIA Lung Adenocarcinoma Patients with EGFR Mutation (ICWIP Study): Study Protocol for a Randomised Controlled Trial. Cancer Manag Res. 2020 Jun 17;12:4633-4643. doi: 10.2147/CMAR.S240275. eCollection 2020.
PubMed 32606956
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Icotinib as an Adjuvant Therapy for Stage II-IIIA Adenocarcinoma With EGFR Mutation: A Placebo-controlled, Randomized, Double-blind, Phase III Study
- ClinicalTrials.gov ID
- NCT02125240
- Acronym / sponsor ID
- ICWIP / BD-IC-IV-59
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 29 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.
The purpose of this study is to compare 3years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.
Detailed description
This study is designed to compare 3 years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.
Primary Outcome Measure:
Disease-free survival between Icotinib group and placebo group.
Secondary Outcome Measures:
Overall survival between Icotinib group and placebo group. Lung cancer symptoms and health-related quality of life (HRQoL) . Number of participants with adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Icotinib | Experimental | Drug: Icotinib125 mg three times daily (375 mg per day) by mouth |
| Placebo | Active comparator | Drug: Placebo1 tablet three times daily by mouth |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pathologically confirmed lung adenocarcinoma after surgical resection
- Stage II-IIIA disease according to 7th edition of TNM staging
- Patients must harbor sensitive EGFR gene mutation (19/21)
- Received four cycles of platinum-based adjuvant chemotherapy.There are many different kinds of chemotherapy regimens including vinorelbine, gemcitabine, docetaxel, paclitaxel, pemetrexed plus cisplatin or carboplatin.The first cycle of chemotherapy with cisplatin dose of 75 mg / m2 ± 10% or carboplatin AUC = 5 ± 10% to calculate the dose of chemotherapy
Key exclusion criteria (5 listed)
- Previous systemic anti-tumor therapy, including chemotherapy or targeted therapy(Including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitor, etc
- Presence of metastatic disease
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- Any unresolved chronic toxicity from previous anticancer therapy
- Received antitumor radiation therapy (except for the stage IIIA N2 patients who received adjuvant radiotherapy after surgery)
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: BPI-2009, Conmana125 mg three times daily (375 mg per day) by mouth | Drug | Icotinib |
| Placebo1 tablet three times daily by mouth | Drug | Placebo |
Primary outcome
Disease-free survival
Time frame: 36 months
DFS was defined as the time from the date of first dose of study medication to the date of death due to disease recurrence or disease progression.
3 secondary outcomes
Overall survival
Time frame: 60 months
Lung cancer symptoms and health-related quality of life (HRQoL) differences
Time frame: 60 months
Number of participants with adverse events
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
- Derived from this study: PubMed 42660909Liu YT, Tang L, Han XH, Song ZY, Liu DR, Cheng G, Xiao WH, Zhang SC, Hu Y, Zhang L, Liu JF, Wang J, Dong GL, Shi YK. Three-year adjuvant treatment of icotinib in stage II-IIIA EGFR-mutated lung adenocarcinoma (ICWIP): a randomized, double-blind, placebo-controlled phase 3 trial. Signal Transduct Target Ther. 2026 Aug 28;11(1):354. doi: 10.1038/s41392-026-02994-w.
- Derived from this study: PubMed 32606956Liu YT, Hao XZ, Liu DR, Cheng G, Zhang SC, Xiao WH, Hu Y, Liu JF, He M, Ding CM, Zhang L, Wang J, Li H, Dong GL, Zhi XY, Li J, Shi YK. Icotinib as Adjuvant Treatment for Stage II-IIIA Lung Adenocarcinoma Patients with EGFR Mutation (ICWIP Study): Study Protocol for a Randomised Controlled Trial. Cancer Manag Res. 2020 Jun 17;12:4633-4643. doi: 10.2147/CMAR.S240275. eCollection 2020.
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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.
Yuan-Kai Shi, MD contact
Yuan-Kai Shi, MD principal investigator
Cancer Hospital Chinese Academy of Medical Science
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Icotinib in people with EGFR Positive Non-small Cell Lung Cancer and Adenocarcinoma, run by Betta Pharmaceuticals Co., Ltd. at 11 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 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 16 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Yuan-Kai Shi, MD (010-87788293), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: 36 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 NCT02125240, 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 16 Jul 2018.