The Role of Icotinib in the Perioperative Treatment of IIIA - IIIB NSCLC Patients With EGFR Mutation
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|ClinicalTrials.gov Identifier: NCT02820116|
Recruitment Status : Recruiting
First Posted : June 30, 2016
Last Update Posted : June 30, 2016
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer(NSCLC)||Drug: Icotinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||67 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||April 2023|
Patients receive Icotinib PO TID for 8 weeks and then undergo thoracotomy.
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.
Other Name: Conmana
- Complete resection rate [ Time Frame: Complete resection rate is depended on the pathology diagnosis after surgery, an expected average of 8 weeks from enrollment. ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02820116
|Contact: Yuqing Huang, firstname.lastname@example.org|
|Contact: Jun liu, email@example.com|
|Beijing Haidian Hospital||Recruiting|
|Beijing, Beijing, China, 100080|
|Contact: Yuqing Huang, Doctor +8601082693152 firstname.lastname@example.org|
|Principal Investigator:||Jun liu, doctor||Peking University People Hospital|