Lung CancerPhase 3ICTANNCT01996098
Icotinib Following Chemotherapy Versus Chemotherapy as Adjuvant Therapy in Stage IIA-IIIA NSCLC With EGFR Mutation
A Phase 3 study testing 6-month Icotinib and 12-month icotinib in people with Lung Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is studying icotinib following chemotherapy to see how well it works compared to chemotherapy in treating patients with resected stage IIA-IIIA NSCLC harboring EGFR mutation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- 6-month Icotinib and 12-month icotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2014to 15 Feb 2024
- 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
- Written informed consent provided.
- Aged 18-75 years.
- Had completely resected pathological confirmed stage IIA-IIIA NSCLC.
- EGFR activating mutation in exon 19 or 21.
- Had completed four cycles of platinum-based adjuvant chemotherapy.
- Able to start the investigational therapy within 4 weeks after the completion of four cycles of adjuvant chemotherapy.
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- ECOG performance status of 0-1.
- Had a life expectancy of 12 weeks or more.
- Adequate hematological function, adequate liver function and renal function.
- Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
- Female patients, except those who are postmenopausal or surgically sterilized, must have a negative pre-study serum or urine pregnancy test.
Who cannot join
- Had had previous chemotherapy besides four cycles of adjuvant chemotherapy, radiotherapy, or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
- Had a history another malignancy in the last 5 years with the exception of cured basal cell carcinoma of the skin, cured in situ carcinoma of the uterine cervix and cured epithelial carcinoma of the bladder.
- Any evidence confirmed tumor recurrence before investigational therapy.
- Known severe hypersensitivity to icotinib or any of the excipients of this product.
- Evidence of clinically active interstitial lung disease.
- Eye inflammation not fully controlled or conditions predisposing the subject to this.
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- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
- Known human immunodeficiency virus (HIV) infection.
- Pregnancy or breast-feeding women.
- Ingredients mixed with small cell lung cancer patients.
- History of neurologic or psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Phase III Trial of Chemotherapy Followed by 6-month or 12-month Icotinib Versus Chemotherapy as Adjuvant Therapy in Stage IIA-IIIA Non-small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutation
The purpose of this study is studying icotinib following chemotherapy to see how well it works compared to chemotherapy in treating patients with resected stage IIA-IIIA NSCLC harboring EGFR mutation.
Read the detailed description
Adjuvant chemotherapy is recommended for routine use in patients with fully resected stage IIA-IIIA non-small cell lung cancer (NSCLC). Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with advanced non-small cell lung cancer (NSCLC) with EGFR mutation. Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists. In the phase III ICOGEN trial, icotinib had non-inferiority efficacy to gefitinib with better safety. In phase II trial, chemotherapy followed by 6-month gefitinib as adjuvant therapy can confer longer disease-free survival compared with chemotherapy alone in patients with resected stage IIIA-N2 non-small cell lung cancer harboring EGFR mutations. This study is to studying 6-month or 12-month icotinib following chemotherapy to see how well it works compared to chemotherapy in treating patients with resected stage IIA-IIIA NSCLC harboring EGFR mutation.
- Conditions
- Lung Cancer
- Being tested
- 6-month Icotinib, 12-month icotinib
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-month IcotinibDrug
Also called BPI-2009, Conmana
125 mg three times daily (375 mg per day) by mouth for 6 months
12-month icotinibDrug
Also called BPI-2009, Conmana
125 mg three times daily (375 mg per day) by mouth for 12 months
| Study group | Role | What they receive |
|---|---|---|
| 6-month icotinib | Experimental | Icotinib 125 mg three times daily (375 mg per day) by mouth for 6 months Receives: Drug: 6-month Icotinib |
| 12-month icotinib | Experimental | Icotinib 125 mg three times daily (375 mg per day) by mouth for 12 months Receives: Drug: 12-month icotinib |
| Chemotherapy alone | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival
Disease-free survival was assessed from randomization to disease recurrence or death as a result of any cause.
Measured: 5 years after the last patient is randomized
Secondary outcomes (3)
Overall Survival
Overall survival was assessed from randomization to death as a result of any cause.
Measured: 5 years after the last patient is randomized
Number of Participants with Adverse Events
To assess if the addition of icotinib to chemotherapy is safe.
Measured: 2 years
Change from baseline in patient reported Lung Cancer Functional Assessment
Quality of life as measured by the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) questionnaire.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study start1 Jan 2014
- Primary completion31 Dec 2021
- Study completion15 Feb 2024
Why it stopped: Slow accural.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- None (open label)
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Si-Yu Wang, Sun Yat-sen University
- Investigators
- Si-Yu Wang, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996098
- Sponsor's protocol ID
- GASTO1002
- Other IDs
- wsy003
- Acronym
- ICTAN
- Status last verified
- Sep 2024
- First submitted
- 21 Nov 2013
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li N, Ou W, Cheng C, You J, Yang L, Chen FX, Liang Y, Yang Z, Wang BX, Chang ZH, Lin YB, Yang W, Xu F, Ding G, Chen XS, Hu R, Li S, Jiang H, Hu XX, Long H, Wang SY. Adjuvant icotinib for resected EGFR-mutated stage II-IIIA non-small-cell lung cancer (ICTAN, GASTO1002): a randomized comparison study. Signal Transduct Target Ther. 2025 Aug 28;10(1):273. doi: 10.1038/s41392-025-02358-w.
PubMed 40866342
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Phase III Trial of Chemotherapy Followed by 6-month or 12-month Icotinib Versus Chemotherapy as Adjuvant Therapy in Stage IIA-IIIA Non-small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutation
- ClinicalTrials.gov ID
- NCT01996098
- Acronym / sponsor ID
- ICTAN / GASTO1002
- Conditions
- Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accural.
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 27 Nov 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.
The purpose of this study is studying icotinib following chemotherapy to see how well it works compared to chemotherapy in treating patients with resected stage IIA-IIIA NSCLC harboring EGFR mutation.
Detailed description
Adjuvant chemotherapy is recommended for routine use in patients with fully resected stage IIA-IIIA non-small cell lung cancer (NSCLC). Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with advanced non-small cell lung cancer (NSCLC) with EGFR mutation. Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists. In the phase III ICOGEN trial, icotinib had non-inferiority efficacy to gefitinib with better safety. In phase II trial, chemotherapy followed by 6-month gefitinib as adjuvant therapy can confer longer disease-free survival compared with chemotherapy alone in patients with resected stage IIIA-N2 non-small cell lung cancer harboring EGFR mutations. This study is to studying 6-month or 12-month icotinib following chemotherapy to see how well it works compared to chemotherapy in treating patients with resected stage IIA-IIIA NSCLC harboring EGFR mutation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 6-month icotinib | Experimental | Drug: 6-month IcotinibIcotinib 125 mg three times daily (375 mg per day) by mouth for 6 months |
| 12-month icotinib | Experimental | Drug: 12-month icotinibIcotinib 125 mg three times daily (375 mg per day) by mouth for 12 months |
| Chemotherapy alone | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent provided.
- Aged 18-75 years.
- Had completely resected pathological confirmed stage IIA-IIIA NSCLC.
- EGFR activating mutation in exon 19 or 21.
- Had completed four cycles of platinum-based adjuvant chemotherapy.
Key exclusion criteria (11 listed)
- Had had previous chemotherapy besides four cycles of adjuvant chemotherapy, radiotherapy, or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
- Had a history another malignancy in the last 5 years with the exception of cured basal cell carcinoma of the skin, cured in situ carcinoma of the uterine cervix and cured epithelial carcinoma of the bladder.
- Any evidence confirmed tumor recurrence before investigational therapy.
- Known severe hypersensitivity to icotinib or any of the excipients of this product.
- Evidence of clinically active 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 |
|---|---|---|
| 6-month IcotinibAlso: BPI-2009, Conmana125 mg three times daily (375 mg per day) by mouth for 6 months | Drug | 6-month icotinib |
| 12-month icotinibAlso: BPI-2009, Conmana125 mg three times daily (375 mg per day) by mouth for 12 months | Drug | 12-month icotinib |
Primary outcome
Disease-Free Survival
Time frame: 5 years after the last patient is randomized
Disease-free survival was assessed from randomization to disease recurrence or death as a result of any cause.
3 secondary outcomes
Overall Survival
Time frame: 5 years after the last patient is randomized
Number of Participants with Adverse Events
Time frame: 2 years
Change from baseline in patient reported Lung Cancer Functional Assessment
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Slow accural.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Derived from this study: PubMed 40866342Li N, Ou W, Cheng C, You J, Yang L, Chen FX, Liang Y, Yang Z, Wang BX, Chang ZH, Lin YB, Yang W, Xu F, Ding G, Chen XS, Hu R, Li S, Jiang H, Hu XX, Long H, Wang SY. Adjuvant icotinib for resected EGFR-mutated stage II-IIIA non-small-cell lung cancer (ICTAN, GASTO1002): a randomized comparison study. Signal Transduct Target Ther. 2025 Aug 28;10(1):273. doi: 10.1038/s41392-025-02358-w.
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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.
Si-Yu Wang, MD principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 6-month Icotinib and 12-month icotinib in people with Lung Cancer, run by Sun Yat-sen University 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 11 inclusion and 11 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: stopped early, as of the sponsor's last update on 5 Sep 2024. 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 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?
The study was stopped early (reason given: Slow accural.). 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?
Disease-Free Survival (time frame: 5 years after the last patient is randomized). 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 NCT01996098, which also lists 1 linked publication.
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 5 Sep 2024.