Non-Small Cell Lung CancerPhase 2NCT05514314
A Multicenter Prospective Study to Assess the Effects of Adjuvant Icotinib in EGFRm Stage I NSCLC With High-risk of Disease Recurrence After Complete Resection
A Phase 2 study testing Icotinib in people with Non-Small Cell Lung Cancer, run by Wu Nan.
Trial summary
This is a multicenter single arm study, with an aim to assess the effects of adjuvant icotinib among EGFR mutant stage I lung adenocarcinoma patients, who have high-risk pathological features of recurrence. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Icotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 30 Jun 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, at least ≥ 18 years，and ≦ 80 years
- Lung adenocarcinoma.
- Stage I disease(IA or IB), based on TNM8 classification.
- There is at least one of the following high-risk factors:
- pathologically confirmed vascular invasion positive;
- pathologically confirmed lung adenocarcinoma containing solid or micropapillary or complex gland histology, with a percentage > 20%;
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- pathologically confirmed invasive tumor size > 2 cm;
- pathologically confirmed visceral pleural involvement (T2a).
- Started adjuvant therapy in this study 4-6 weeks after complete resection without any previous antitumor therapy.
- A tumour which harbours one of the 2 EGFR mutations (Ex19del, L858R) ,without KRAS mutation
- World Health Organization performance status of 0 or 1.
- Bood routine: HB > 80g/L; ANC > 1.0x109/L; PLT > 50x109/L.Blood biochemistry： ALT and AST < 2.5 times the upper limit of normal; Crea < 1.5 times the upper limit of normal.
- Good adherence to follow-up.
- During the trial and for 3 months after the trial，Participants must be using highly effective contraceptive measures.
Who cannot join
- Prior treatment with any anticancer therapy for NSCLC (including chemotherapy, radiotherapy, immunotherapy, and EGFR-TKIs).
- Local radiotherapy.
- Patients with cancers other than NSCLC (except cured cervical carcinoma in situ, cured basal cell carcinoma and bladder epithelial tumors) within 5 years prior to the start of treatment in this study.
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, angina pectoris beginning within the last 3 months, congestive heart failure, myocardial infarction occurring within 6 months prior to enrollment, severe arrhythmia requiring medication, liver, kidney or metabolic disease).
- Any clinical evidence suggestive of active interstitial lung disease.
- An eye inflammation or eye infection that is not fully controlled, or any condition that could lead to one of these eye conditions.
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- Known human immunodeficiency virus (HIV) infection.
- Known hypersensitivity to EGFR-TKI drugs or related components.
- Mixed small cell and non-small cell cancer history.
- Substance abuse, or illnesses such as psychological or psychiatric disorders that may interfere with study compliance.
- Patients with epilepsy requiring medication (e.g. steroids or anti-epileptic drugs).
- Other conditions deemed unsuitable for enrollment by the investigator.
About this study
This is a multicenter single arm study, with an aim to assess the effects of adjuvant icotinib among EGFR mutant stage I lung adenocarcinoma patients, who have high-risk pathological features of recurrence.
- 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
Within 4-6 weeks after surgery, Icotinib 125mg orally, TID was started for 2 years, or treatment was discontinued due to tumor recurrence or intolerance
| Study group | Role | What they receive |
|---|---|---|
| Icotinib | Experimental | Icotinib oral 125mg tid for 2 years Receives: Drug: Icotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-Free Survival (RFS)
RFS is defined as the time from the date of curative resection to the first documented recurrence or death due to any cause, whichever occurs first.
Measured: Up to approximately 10 years
Secondary outcomes (2)
Overall Survival (OS)
OS is defined as the time from the date of randomisation until death due to any cause.
Measured: Up to approximately 10 years
Safety and tolerability
AEs graded by CTCAE version 5.0
Measured: Up to approximately 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Jun 2025 (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.
- 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wu Nan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wu Nan, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05514314
- Sponsor's protocol ID
- BD-IC-IV96
- Status last verified
- Aug 2022
- First submitted
- 22 Aug 2022
- Last updated
- 24 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Study to Assess the Effects of Adjuvant Icotinib in EGFRm Stage I NSCLC With High-risk of Disease Recurrence After Complete Resection
- ClinicalTrials.gov ID
- NCT05514314
- Acronym / sponsor ID
- BD-IC-IV96
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Wu NanUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 24 Aug 2022 (actual)
- 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 is a multicenter single arm study, with an aim to assess the effects of adjuvant icotinib among EGFR mutant stage I lung adenocarcinoma patients, who have high-risk pathological features of recurrence.
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: IcotinibIcotinib oral 125mg tid for 2 years |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female, at least ≥ 18 years，and ≦ 80 years
- Lung adenocarcinoma.
- Stage I disease(IA or IB), based on TNM8 classification.
- There is at least one of the following high-risk factors:
- Started adjuvant therapy in this study 4-6 weeks after complete resection without any previous antitumor therapy.
Key exclusion criteria (12 listed)
- Prior treatment with any anticancer therapy for NSCLC (including chemotherapy, radiotherapy, immunotherapy, and EGFR-TKIs).
- Local radiotherapy.
- Patients with cancers other than NSCLC (except cured cervical carcinoma in situ, cured basal cell carcinoma and bladder epithelial tumors) within 5 years prior to the start of treatment in this study.
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, angina pectoris beginning within the last 3 months, congestive heart failure, myocardial infarction occurring within 6 months prior to enrollment, severe arrhythmia requiring medication, liver, kidney or metabolic disease).
- Any clinical evidence suggestive of 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 |
|---|---|---|
| IcotinibWithin 4-6 weeks after surgery, Icotinib 125mg orally, TID was started for 2 years, or treatment was discontinued due to tumor recurrence or intolerance | Drug | Icotinib |
Primary outcome
Recurrence-Free Survival (RFS)
Time frame: Up to approximately 10 years
RFS is defined as the time from the date of curative resection to the first documented recurrence or death due to any cause, whichever occurs first.
2 secondary outcomes
Overall Survival (OS)
Time frame: Up to approximately 10 years
Safety and tolerability
Time frame: Up to approximately 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Wu Nan.
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 14 inclusion and 12 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 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Recurrence-Free Survival (RFS) (time frame: Up to approximately 10 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 24 Aug 2022.