Non-small Cell Lung Cancer(NSCLC)Phase 2NCT02820116
The Role of Icotinib in the Perioperative Treatment of IIIA - IIIB NSCLC Patients With EGFR Mutation
A Phase 2 study testing Icotinib in people with Non-small Cell Lung Cancer(NSCLC), run by Beijing Haidian Hospital at 1 site in China.
Trial summary
This is an open-label, multicenter, single-arm, phase II interventional clinical trial evaluating efficacy and safety of Icotinib as neoadjuvant treatment in patients with IIIA- IIIB NSCLC with activating EGFR mutation in exon 19 or 21. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-small Cell Lung Cancer(NSCLC)
- 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
- 67 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Apr 2023
- 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
- Provision of informed consent
- Pathologically confirmed non-small cell lung cancer with EGFR exon 19 deletion or exon 21 L858 mutation.
- Clinically or pathologically confirmed stage IIIA- IIIB
- Tolerable to complete resection of lung cancer
- Able to comply with the required protocol and follow-up procedures, and able to receive oral medications
- ECOG performance status 0-1.
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- Life expectancy ≥12 weeks.
- Measurable disease must be characterized according to RECIST 1.1 criteria. Measurable lesions are defined as those that can be accurately measured in at least one dimension as ≥ 10mm by spiral CT scan.
- Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥10 g/dL (may be transfused to maintain or exceed this level).
- Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); Aspartate amino transferase (AST) and alanine amino transferase (ALT) ≤ 2.5 x upper limit of normal (ULN).
- Adequate renal function: Serum creatinine ≤ 1.25 x upper limit of normal (ULN), and creatinine clearance≥ 60 ml/min.
- Measurable disease according to the preset criteria .
Who cannot join
- Patients with prior exposure to chemotherapy, irradiation or systemic anti-cancer therapy (e.g. monoclonal antibody therapy) for lung cancer.
- Known severe hypersensitivity to Icotinib or any of the excipients of this product
- Previous or current malignancies of other histologies within the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free survival of 5 years; cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix.
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within six months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
- Interstitial lung disease(ILD) or pulmonary fibrosis; impaired pulmonary function.
- Eye inflammation or eye infection not fully treated or predisposing factor of this.
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- Uncontrolled central nervous system (CNS) metastasis.
- Any serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study
- Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the subject at high risk for treatment-related complications.
- Pregnancy or breast feeding.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Haidian Hospital
Beijing, Beijing Municipality, 100080
Yuqing Huang, Doctor, +8601082693152, huangyuqing555@gmail.com
About this study
Official title: An Open-label, Multicenter，Single-arm, Phase II Clinical Study of Icotinib for IIIA - IIIB NSCLC Patients With Epidermal Growth Factor Receptor Mutation
This is an open-label, multicenter, single-arm, phase II interventional clinical trial evaluating efficacy and safety of Icotinib as neoadjuvant treatment in patients with IIIA- IIIB NSCLC with activating EGFR mutation in exon 19 or 21. Sixty-seven resectable stage IIIA- IIIB NSCLC patients with EGFR activating (19/21) mutations will be eligible to be enrolled. EGFR mutation will be prospectively tested in all the participants' biopsy samples and confirmed in surgical resected samples.
Neoadjuvant treatment phase:
Read more
Eligible patients will receive 125mg of Icotinib three times per day. Treatment will be scheduled to continue until the disease progression or unbearable toxicities appear.
Surgery treatment phase:
Tumor response will be evaluated with CT scan after 8 weeks of induction treatment. The patients with responsive disease considered to be technique resectable will undergo resection.
Post-surgery phase:
It is the discretion of the investigator whether the patient is a candidate for post-operative treatment which is considered to be in the best interest of the patients. It is recommended that patients with positive margins or residual tumor after surgery should receive radiation therapy. Patients after surgery will receive long-term follow-up -- chest CT scan，abdominal abdominal ultrasound every 3 months, brain MRI every 6 months, bone scan (ECT) every 12 months -- for up to 5 years.
- Conditions
- Non-small Cell Lung Cancer(NSCLC)
- 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 Conmana
In the neoadjuvant treatment phase, eligible patients will receive 125mg of Icotinib three times per day for 8 weeks (56 days). In the post-surgery phase, Icotinib 125mg/three tims/day taken orally for 2 years or till disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Icotinib | Experimental | Patients receive Icotinib PO TID for 8 weeks and then undergo thoracotomy. Receives: Drug: Icotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete resection rate
Measured: Complete resection rate is depended on the pathology diagnosis after surgery, an expected average of 8 weeks from enrollment.
Secondary outcomes (6)
Objective response rate(ORR, i.e., complete response [CR] + partial response [PR])
Measured: Up to 5 years
Disease control rate (CR + PR+ stable disease)
Measured: Up to 5 years
Clinical down-staging
Measured: 8 weeks
Progression free survival (PFS)
Measured: Participants after surgery will receive long-term follow-up for up to 5 years
Overall survival (OS)
Measured: Participants after surgery will receive long-term follow-up for up to 5 years
Number of Adverse Event
Measured: Within 28 days of last study dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (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 Cancer(NSCLC)Studies 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
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Haidian Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University People's Hospital, 307 Hospital of PLA, 309th Hospital of Chinese People's Liberation Army
- Responsible party
- Principal investigator, Huang Yuqing, Beijing Haidian Hospital
- Investigators
- Jun liu, doctor, Principal investigator, Peking University People Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820116
- Sponsor's protocol ID
- RIPOT1606
- Status last verified
- May 2016
- First submitted
- 22 Jun 2016
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter，Single-arm, Phase II Clinical Study of Icotinib for IIIA - IIIB NSCLC Patients With Epidermal Growth Factor Receptor Mutation
- ClinicalTrials.gov ID
- NCT02820116
- Acronym / sponsor ID
- RIPOT1606
- Conditions
- Non-small Cell Lung Cancer(NSCLC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Beijing Haidian HospitalUniversity, hospital or other
- Collaborators
- Peking University People's Hospital, 307 Hospital of PLA, 309th Hospital of Chinese People's Liberation Army
- Study start
- May 2016
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 30 Jun 2016 (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 is an open-label, multicenter, single-arm, phase II interventional clinical trial evaluating efficacy and safety of Icotinib as neoadjuvant treatment in patients with IIIA- IIIB NSCLC with activating EGFR mutation in exon 19 or 21. Sixty-seven resectable stage IIIA- IIIB NSCLC patients with EGFR activating (19/21) mutations will be eligible to be enrolled. EGFR mutation will be prospectively tested in all the participants' biopsy samples and confirmed in surgical resected samples.
Neoadjuvant treatment phase:
Eligible patients will receive 125mg of Icotinib three times per day. Treatment will be scheduled to continue until the disease progression or unbearable toxicities appear.
Surgery treatment phase:
Tumor response will be evaluated with CT scan after 8 weeks of induction treatment. The patients with responsive disease considered to be technique resectable will undergo resection.
Post-surgery phase:
It is the discretion of the investigator whether the patient is a candidate for post-operative treatment which is considered to be in the best interest of the patients. It is recommended that patients with positive margins or residual tumor after surgery should receive radiation therapy. Patients after surgery will receive long-term follow-up -- chest CT scan，abdominal abdominal ultrasound every 3 months, brain MRI every 6 months, bone scan (ECT) every 12 months -- for up to 5 years.
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 PO TID for 8 weeks and then undergo thoracotomy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Provision of informed consent
- Pathologically confirmed non-small cell lung cancer with EGFR exon 19 deletion or exon 21 L858 mutation.
- Clinically or pathologically confirmed stage IIIA- IIIB
- Tolerable to complete resection of lung cancer
- Able to comply with the required protocol and follow-up procedures, and able to receive oral medications
Key exclusion criteria (10 listed)
- Patients with prior exposure to chemotherapy, irradiation or systemic anti-cancer therapy (e.g. monoclonal antibody therapy) for lung cancer.
- Known severe hypersensitivity to Icotinib or any of the excipients of this product
- Previous or current malignancies of other histologies within the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free survival of 5 years; cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix.
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within six months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
- Interstitial lung disease(ILD) or pulmonary fibrosis; impaired pulmonary function.
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: ConmanaIn the neoadjuvant treatment phase, eligible patients will receive 125mg of Icotinib three times per day for 8 weeks (56 days). In the post-surgery phase, Icotinib 125mg/three tims/day taken orally for 2 years or till disease progression or unacceptable toxicity. | Drug | Icotinib |
Primary outcome
Complete resection rate
Time frame: Complete resection rate is depended on the pathology diagnosis after surgery, an expected average of 8 weeks from enrollment.
6 secondary outcomes
Objective response rate(ORR, i.e., complete response [CR] + partial response [PR])
Time frame: Up to 5 years
Disease control rate (CR + PR+ stable disease)
Time frame: Up to 5 years
Clinical down-staging
Time frame: 8 weeks
Progression free survival (PFS)
Time frame: Participants after surgery will receive long-term follow-up for up to 5 years
Overall survival (OS)
Time frame: Participants after surgery will receive long-term follow-up for up to 5 years
Number of Adverse Event
Time frame: Within 28 days of last study dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
- Individual participant dataSharing planned: Undecided
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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.
Jun liu, doctor principal investigator
Peking University People Hospital
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(NSCLC), run by Beijing Haidian Hospital 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 12 inclusion and 10 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 30 Jun 2016. 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 Yuqing Huang, doctor (+8601082693152, huangyuqing555@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete resection rate (time frame: Complete resection rate is depended on the pathology diagnosis after surgery, an expected average of 8 weeks from enrollment.). 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 30 Jun 2016.